| Internal medicine |
1 |
•Too severe atopic dermatitis defined as the sum of scores is 80 and above by SCORAD index.
•A history of liver disease; allergy to montelukast or cross-reacting medication; use of phenobarbital, phenytoin or rifampicin.
•Patients on systemic steroids, immune-suppression or Korean herbal medicine during the previous 6 weeks. |
| 2 |
•Had investigational product permanently discontinued at any time during a previous baricitinib study.
•Had temporary investigational product interruption continue at the final study visit of a previous baricitinib study and, in the opinion of the investigator, this poses an unacceptable risk for the participant's participation in the study |
| 3 |
•Are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus), or a history of erythrodermic, refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections.
•A history of eczema herpeticum within 12 months, and/or a history of 2 or more episodes of eczema herpeticum in the past.
•Participants who are currently experiencing a skin infection that requires treatment, or is currently being treated, with topical or systemic antibiotics.
•Have any serious illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g., unstable chronic asthma).
•Have been treated with the following therapies:
◦Monoclonal antibody for less than 5 half-lives prior to randomization.
◦Received prior treatment with any oral Janus kinase (JAK) inhibitor less than 4 weeks prior to randomization.
◦Received any parenteral corticosteroids administered by intramuscular or intravenous (IV) injection within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study.
◦Have had an intra-articular corticosteroid injection within 6 weeks prior to planned randomization.
•Have high blood pressure characterized by a repeated systolic blood pressure >160 millimeters of mercury (mm Hg) or diastolic blood pressure >100 mm Hg.
•Have had major surgery within the past eight weeks or are planning major surgery during the study.
•Have experienced any of the following within 12 weeks of screening: venous thromboembolic event (VTE), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.
•Have a history of recurrent (≥2) VTE or are considered at high risk of VTE as deemed by the investigator.
•Have a history or presence of cardiovascular, respiratory, hepatic, chronic liver disease gastrointestinal, endocrine, hematological, neurological, lymphoproliferative disease or neuropsychiatric disorders or any other serious and/or unstable illness.
•Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection including herpes zoster, tuberculosis.
•Have specific laboratory abnormalities.
•Have received certain treatments that are contraindicated.
•Pregnant or breastfeeding. |
| 4 |
•Are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus), or a history of erythrodermic, refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections.
•A history of eczema herpeticum within 12 months, and/or a history of 2 or more episode of eczema herpeticum in the past.
•Participants who are currently experiencing a skin infection that requires treatment, or is currently being treated, with topical or systemic antibiotics.
•Have any serious illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g., unstable chronic asthma).
•Have been treated with the following therapies:
◦Monoclonal antibody for less than 5 half-lives prior to randomization.
◦Received prior treatment with any oral Janus kinase (JAK) inhibitor.
◦Received any parenteral corticosteroids administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study.
◦Have had an intra-articular corticosteroid injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization.
•Have high blood pressure characterized by a repeated systolic blood pressure >160 millimeters of mercury (mm Hg) or diastolic blood pressure >100 mm Hg.
•Have had major surgery within the past eight weeks or are planning major surgery during the study.
•Have experienced any of the following within 12 weeks of screening: venous thromboembolic event (VTE), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.
•Have a history of recurrent (≥ 2) VTE or are considered at high risk of VTE as deemed by the investigator.
•Have a history or presence of cardiovascular, respiratory, hepatic, chronic liver disease gastrointestinal, endocrine, hematological, neurological, lymphoproliferative disease or neuropsychiatric disorders or any other serious and/or unstable illness.
•Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection including herpes zoster, tuberculosis.
•Have specific laboratory abnormalities.
•Have received certain treatments that are contraindicated.
•Pregnant or breastfeeding. |
| 5 |
•Prior exposure to any Janus kinase (JAK) inhibitor
•Unable or unwilling to discontinue current AD treatments prior to the study
•Requirement of prohibited medications during the study
•Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions
•Female subject who is pregnant, breastfeeding, or considering pregnancy during the study |
| 6 |
•Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
•Currently have active forms of other inflammatory skin diseases, ie, not atopic dermatitis.
•Have evidence of skin conditions (eg, psoriasis, seborrheic dermatitis, Lupus) at the time of Day 0 that would interfere with evaluation of atopic dermatitis or response to treatment. |
| 7 |
•Discontinued from treatment (or rescue treatment period, if applicable) early in a qualifying Phase 3 study OR triggered discontinuation criteria at any point during the qualifying Phase 3 study OR meets exclusion criteria of the qualifying Phase 3 study.
•Ongoing adverse event in the qualifying Phase 3 study which in the opinion of the investigator, or sponsor, is an ongoing safety concern OR the subject is currently triggering safety monitoring criteria in the qualifying Phase 3 study.
•Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study. |
| 8 |
•Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
•Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
•Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
•Other active nonAD inflammatory skin diseases or conditions affecting skin
•Prior treatment with JAK inhibitors
•Previous treatment with dupilumab
•Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study |
| 9 |
• If you have other skin diseases or systemic diseases other than atopic dermatitis, they are excluded from the study.
• Exclude patients who have been orally administered steroids and immunosuppressive agents up to one week before the subject interview (dermatologic agents are irrelevant).
• Pregnant women who are breastfeeding or who do not have adequate contraception are excluded.
• Excludes those who have clinically significant liver disease or LFT elevated more than twice the reference value.
• Those who have participated in other clinical trials within one month before the start of the study are excluded.
• Exclude individuals with irritable allergies to study-related drugs.
• Exclude those who have digestive disorders after having a disease that may affect the absorption of the drug or surgery associated therewith.
• Mentally retarded Excludes those who do not understand the agreement or are unable to follow the study due to emotional intellectual problems.
• Exclude those who are deemed inappropriate by other clinical trial personnel. |
| Dermatologic agents |
10 |
•Those who have a history of hypersensitivity or clinically significant hypersensitivity reactions to generic drugs (aspirin, antibiotics, etc.)
•Those who have clinically significant liver, kidney, respiratory, endocrine, neurologic diseases or hematologic diseases, mental diseases, especially hemorrhagic diseases (hemophilia, von Willebrand disease, etc.), cardiovascular diseases (coronary artery disease, Congestive heart failure, arrhythmia, cerebrovascular disease, etc.) or who have a history of those diseases
•Those who had clinical symptoms suspected of acute infectious disease within 2 weeks before the scheduled date of the first administration, or whose temperature measured by the screening test (eardrum) was 38.0 ° C or higher
•Those who have taken any prescription drugs, herbal medicines, crude drugs within 2 weeks before the scheduled date of administration of the medicines for clinical trials , or over-the-counter medicines or vitamin preparations within 1 week.
•Those who have a history of substance abuse, or positive urine screening tests (cannabinoid, opiates, amphetamine, cocaine, barbiturate, benzodiazepine)
•Those who have a history of smoking within 3 months (However, if they quit smoking three months before the first scheduled medication, they are eligible for selection)
•Those who have been found to be positive in serological tests (HBs antigen, hepatitis C virus antibody and HIV antibody)
•Those who drink continuously (above 21 units / week, 1 unit = 10 g of pure alcohol)
•Those who have been taking medicines by participating in other clinical trials or bioequivalence studies within 3 months prior to the date of first dosing
•Those who have been bleeding, blood drawings or blood donation of 400mL or more within 8 weeks before the scheduled date of administration of the drug for clinical trials
•Those who have vital signs measured at sitting position after the break for more than 3 minutes,
◦Low blood pressure (systolic blood pressure <90 mmHg, diastolic blood pressure <50 mmHg)
◦High blood pressure (systolic blood pressure greater than 150 mmHg, diastolic blood pressure greater than 100 mmHg)
•Test subjects who are deemed unsuitable for participating in clinical trials due to clinical laboratory tests, ECG results, or other reasons |
| 11 |
•Who has skin diseases other than atopic dermatitis or scar in the affected area which can affect the study, determined by the study investigators.
•Who has clinically significant medical history or diseases involving liver, kidney, neurological system, psychical disorder that can affect study results.
•Who has used systemic steroids, antibiotics, immunosuppressants, or received photochemical therapy within 28 days before study drug administration.
•Who has used topical steroids, immunosuppressants or antibiotics to treat atopic dermatitis within 14 days before study drug administration.
•Who has used or is expected to inevitably use prohibited concomitant medications during the study.
•Women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives.
•Who has dosed other study medications within 30 days before screening.
•Who is determined ineligible for study participation by investigators for any other reasons. |
| 12 |
•Who has skin diseases other than atopic dermatitis or scar in the affected area which can affect the study, determined by the study investigators.
•Who has clinically significant medical history or diseases involving liver, kidney, neurological system, psychical disorder that can affect study results.
•Who has used systemic steroids, antibiotics, immunosuppressants, or received phototherapy within 28 days before study drug administration.
•Who has used topical steroids, topical calcineurin inhibitors or antibiotics to treat atopic dermatitis within 14 days before study drug administration.
•Who has used or is expected to inevitably use prohibited concomitant medications during the study.
•Women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives.
•Who has dosed other study medications within 30 days before screening.
•Who is determined ineligible for study participation by investigators for any other reasons. |
| 13 |
•Who has skin diseases other than atopic dermatitis or scar in the affected area which can affect the study, determined by the study investigators.
•Who has clinically significant medical history or diseases involving liver, kidney, neurological system, psychial disorder that can affect study results.
•Who has used systemic steroids, antibiotics, immunosuppressants, or received photochemical therapy within 28 days before study drug administration.
•Who has used topical steroids, immunosuppressants or antibiotics to treat atopic dermatitis within 14 days before study drug administration.
•Who has used or is expected to inevitably use prohibited concomitant medications during the study.
•Women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives.
•Who has dosed other study medications within 30 days before screening.
•Who is determined ineligible for study participation by investigators for any other reasons. |
| 14 |
•Participants have oozing in the lesion
•Users of following medications prior to trial periods
① Oral steroids, immunosuppressants and antibiotics within 4 weeks prior to this trial
② Topical steroids, immunosuppressants and antibiotics within 2 weeks prior to this trial
③ Light therapy within 2 weeks prior to this trial
④ Other medications thought to be inappropriate by researchers
•Participants have severe burn or wide wound
•Participants have oozing or ulcer in the lesion
•Allergic reactions to Angelica gigas, Siebold et Zuccarini, sesame oil and lard
•Participants have skin disease except atopic dermatitis
•Participants have severe renal function disease (sCr > 2.0 mg/dL)
•Participants have severe liver function disease (ALT, AST, ALP ≥ 2.5 × normal limits)
•Participants have uncontrolled chronic diseases
•Pregnancy, lactation
•Participation in another clinical trial within one month of enrolment
•Underlying disease or history of severe disease, abnormal state (paralysis; mental retardation other emotional or mental problems; diseases that can affect the absorption of drugs; no enough time to participate in this trial; visual disturbance and hearing impairment; inability to understand written consent or engage in this study)
•Judgment by experts that the potential subject's participation is inappropriate. |
| 15 |
•Those who have serious skin diseases other than atopic dermatitis
•The subjects were clinically diagnosed with bacterial viruses or fungi, If you have salty atopic dermatitis
•Persons with intractable chronic diseases such as hypertension, chronic active hepatitis, diabetes mellitus
•Pregnant or lactating women or those who are pregnant during the clinical trial
•Those who received oral steroids or oral antibiotics, systemic photochemotherapy and other immunosuppressive agents within 4 weeks of the start of the study
•Persons with liver function or renal impairment
•Those with a history of substance abuse
•The person who showed hypersensitivity to the raw material preparation of CP001
•Those who participated as subjects in other clinical studies within 60 days of the start of the test |
| 16 |
Unknown |
| 17 |
• Concurrent skin diseases (infections)
• Immunocompromised
• Recently received phototherapy or systemic therapy |
| injections |
18 |
Unknown |
| 19 |
•Subjects who have systemic infection at the baseline visit
•Subjects who have asthma at the baseline visit
•Treatment with oral corticosteroids, oral antibiotics, whole body photochemotherapy, immunosuppressive drug within 4 weeks before the baseline visit
•Treatment with topical steroids, antibiotics within 2 weeks before the baseline visit
•Subjects who already took or need to take the medicine which is prohibited to take during the clinical study.
•Pregnant, breast-feeding women or women who plan to become pregnant during this study. (Females of Childbearing Potential must have a negative urine pregnancy test at Screening and Baseline)
•Subjects who currently participate in other clinical trial or participated in other clinical trial within 30 days
•Creatinine value ≥ 2 Upper limit of the normal range at screening test
•AST/ALT value ≥ 2 Upper limit of the normal range at screening test
•Any other condition which the investigator judges would make patient unsuitable for study participation |
| 20 |
•Patients under the age of 13 year.
•Patients who are unable to agree on their own (emergency patients, patients with mental disability, patients with limited capacity to consent due to stroke or delirium caused by diabetes).
•Patients with severe disease whose expected survival duration is less than 3 months.
•Pregnancy or planned pregnancy within 1 year
•Skin condition not appropriate for blood sampling and transfusion
•The standardized clinical severity scoring system for atopic dermatitis (SCORAD) values <25 (Mild atopic dermatitis) |
| 21 |
•Subjects with medical history or surgery/procedure history
•Subjects with diseases at the time of participation in this study (systemic infection, other serious skin disorders, pigmentation or extensive scarring in atopic dermatitis symptom region)
•Subjects who need prohibited medication during clinical period
•Pregnant, breast-feeding women or women who plan to become pregnant during this study
•Subjects who currently participate in other clinical trial or participated in other clinical trial within 4 weeks
•Any other condition which the investigator judges would make patient unsuitable for study participation |
| 22 |
•Active dermatologic conditions that may confound the diagnosis of AD.
•Use of tanning beds or phototherapy within 6 weeks prior to randomisation.
•Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to randomisation.
•Treatment with TCS and/or TCI within 2 weeks prior to randomisation.
•Active skin infection within 1 week prior to randomisation.
•Clinically significant infection within 4 weeks prior to randomisation.
•A helminth parasitic infection within 6 months prior to the date informed consent is obtained.
•Tuberculosis requiring treatment within the 12 months prior to screening.
•Known primary immunodeficiency disorder.
•Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥2.0 times the ULN (upper limit of normal) at screening.
•Positive hepatitis B surface antigen, hepatitis B surface antibody, hepatitis B core antibody or hepatitis C virus antibody serology at screening.
•History of anaphylaxis following any biologic therapy. |
| 23 |
•Patients who, during their participation in a previous dupilumab clinical trial, developed a serious adverse event (SAE) deemed related to dupilumab*, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient.
•Patients who, during their participation in a previous dupilumab clinical trial, developed an AE that was deemed related to dupilumab* and led to study treatment discontinuation, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient.
•Conditions in the previous dupilumab study consistent with protocol-defined criteria for permanent study drug discontinuation, if deemed related to dupilumab* or led to investigator - or sponsor-initiated withdrawal of patient from the study (eg, non-compliance, inability to complete study assessments, etc.).
*Note for exclusion criteria # 1, 2, and 3: In studies that are still blinded, conditions deemed related to the study treatment will be considered related to dupilumab.
•Treatment with an investigational drug, other than dupilumab, within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit
•Pregnant or breastfeeding women, or planning to become pregnant or breastfeed during the patient's participation in this study |
| 24 |
•Participation in a prior Dupilumab clinical trial;
•Important side effects of topical medication (e.g. intolerance to treatment, hypersensitivity reactions, significant skin atrophy, systemic effects), as assessed by the investigator or treating physician;
•Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, was likely to require such treatment(s) during the first 2 weeks of study treatment:
1.Immunosuppressive/immunomodulating drugs (e.g, systemic steroids, cyclosporine, mycophenolate-mofetil, Janus kinase inhibitors, interferon-gamma [IFN-γ], azathioprine, methotrexate, etc.);
2.Phototherapy for AD;
•Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit;
•History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening;
•Positive hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody at the screening visit;
•Active or acute infection requiring systemic treatment within 2 weeks before baseline visit;
•Known or suspected history of immunosuppression;
•Pregnant or breastfeeding women, or planning to become pregnant or breastfeed during the participant's participation in this study. |
| 25 |
•Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
•Prior treatment with JAK inhibitors
•Other active nonAD inflammatory skin diseases or conditions affecting skin
•Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
•Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception |
| 26 |
•Participation in a prior Dupilumab clinical study.
•Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit;
•Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment:
◦Immunosuppressive/ immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
◦Phototherapy for AD
•Regular use (more than 2 visits per week) of a tanning booth/ parlor within 4 weeks of the screening visit;
•Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit;
•History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening;
•Positive with hepatitis B surface antigen (HBsAg) or hepatitis C antibody at the screening visit;
•Active chronic or acute infection requiring systemic treatment within 2 weeks before the baseline visit;
•Known or suspected history of immunosuppression;
•Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study;
•Women unwilling to use adequate birth control, if of reproductive potential and sexually active.
Note: The information listed above is not intended to contain all considerations relevant to a participant's potential participation in this clinical trial therefore not all inclusion/ exclusion criteria are listed. |
| 27 |
•Active dermatologic conditions, which might confound the diagnosis of AD or would interfere with the assessment of treatment, such as scabies, seborrheic dermatitis, cutaneous lymphoma, ichthyosis, psoriasis, allergic contact dermatitis, or irritant contact dermatitis.
•History of a clinically significant infection within 28 days prior to day 1 that, in the opinion of the investigator or medical monitor, might compromise the safety of the subject in the study, interfere with evaluation of the investigational product, or reduce the subject's ability to participate in the study. Clinically significant infections are defined as either of the following: 1) a systemic infection; or 2) a serious skin infection requiring parenteral antibiotic, antiviral, or antifungal medication.
•Diagnosis of a helminth parasitic infection within 6 months prior to screening that had not been treated with or had failed to respond to standard of care therapy.
•Documented medical history of chronic alcohol or drug abuse within 12 months prior to screening.
•History of anaphylaxis following any biologic therapy.
•Evidence of active liver disease at screening, including jaundice or aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase greater than twice the upper limit of normal (ULN).
•Diagnosis and/or treatment of tuberculosis within the 12 months prior to screening.
•Positive hepatitis B surface antigen or hepatitis C antibody serology. Subjects with a history of hepatitis B vaccination without a history of hepatitis B are allowed to enroll in the study.
•Positive human immunodeficiency virus (HIV) test at screening or the subject is taking antiretroviral medications, as determined by medical history, prior medications, and/or the subject's verbal report.
•Other Medical Conditions>
•History of malignancy, except for basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy ≥ 12 months prior to screening or other malignancies treated with apparent success with curative therapy ≥ 5 years prior to screening.
•History or evidence of severe depression, schizophrenia, previous suicide attempts, or suicidal ideation.
Prior/Concomitant Therapy:
•Subjects who are unwilling to abstain from the use of TCS, TCI, prescription moisturizers, or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin from screening through week 16 (applies only to Part A subjects)
•Subjects who have had side effects of topical medications including intolerance to treatment, hypersensitivity reactions, significant skin atrophy, or systemic effects as assessed by the investigator or by the subject's treating physician (applies only to Part B subjects)
•More than or equal to 30% of the total lesional surface is located on areas of thin skin that cannot be safely treated with medium or higher potency TCS (eg, face, neck, intertriginous areas, areas of skin atrophy) (applies only to Part B subjects)
•Receipt of any approved biologic agent (eg, dupilumab) within 4 months prior to screening
•Have used immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, interferon (IFN)-gamma, Janus kinase inhibitors, azathioprine, methotrexate) within 4 weeks prior to screening, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment.
•Have had phototherapy for AD in the 2 months prior to day 1, and subjects unwilling to avoid phototherapy during the first 16 weeks of the study
•If on allergen-specific immunotherapy, subjects must be on a maintenance dose and schedule for ≥ 28 days prior to screening. Allergen-specific immunotherapy is defined as SC immunotherapy to aeroallergens and/o venom (Hymenoptera) as well as sublingual immunotherapy to aeroallergens
•Vaccination with a live or attenuated vaccine within 28 days prior to day 1. Receipt of inactive/killed vaccinations (eg, inactive influenza) is allowed, provided the vaccinations are not administered within 7 days before or after any study visit. Note that receipt of the Th2 cytokine inhibitor suplatast within 15 days prior to screening is allowed.
•Major surgery within 8 weeks prior to screening or planned inpatient surgery or hospitalization during the study period
•Currently receiving treatment in another investigational device or drug study, or less than 6 months since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
Other Exclusions:
•Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 14 weeks after the last dose of investigational product. (Females of childbearing potential should only be enrolled in the study after a negative highly sensitive serum pregnancy test).
•Female subjects of childbearing potential who are sexually active with unsterilized male partners unwilling to use 1 highly effective method of contraception during treatment and for an additional 14 weeks after the last dose of investigational product. Cessation of contraception after this point must be discussed with a responsible physician. Females of childbearing potential are defined as those who are not surgically sterile (ie, had bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause). A highly effective method of contraception is defined as one that resulted in a low failure rate (ie, < 1% per year) when used consistently and correctly. Refer to Appendix 5 for additional contraceptive information.
•Male subjects with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 14 weeks after the last dose of investigational product. Refer to Appendix 5 for additional contraceptive information.
•Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 14 weeks after the last dose of investigational product.
•Male subjects unwilling to abstain from donating sperm during treatment and for an additional 14 weeks after the last dose of investigational product.
•Subject has known sensitivity to any of the products or components to be administered during dosing.
•History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion. |
| 28 |
• Patients with uncontrolled comorbidities such as moderate infections, bleeding
• HBV, HCV, HIV and VDRL positive
• In hypertensive patients whose blood pressure is not controlled to 140 mmHg or DBP 90 mmHg in spite of the administration of antihypertensive agents during screening
• An uncontrolled diabetic patient with an HbA1c value of 8.0 or greater as measured at screening
• Screening requires the use of a second-line modulator or systemic steroid with high-dose inhaled steroids, or an uncontrolled asthma patient
• Patients with skin autoimmune diseases including psoriasis and systemic autoimmune diseases (such as lupus erythematosus, rheumatoid arthritis, and severe workouts)
• Within 4 weeks prior to screening, patients with systemic corticosteroids, systemic immunosuppressants / immune response modifiers, high-frequency topical corticosteroids (WHO Groups I-III), local immunomodulators and biological agents
• Patients with a dose of corticosteroids (WHO Group IV, V), systemic photochemotherapy and systemic antibiotics within 2 weeks before screening
• Patients with antihistamine dosage for oral or injections within 1 week prior to participation in the trial
• Concomitant contraindications Patient who has been treated with medication during the test period
• Pregnant or lactating women
• Women who are not willing to use appropriate contraception during the trial
• Patients participating in other clinical trials or participating in other clinical trials within the past 30 days
• Patients who were judged to be inappropriate by other researchers |
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