Study evaluating PF 04965842 in adolescents with moderate to severe atopic dermatitis on background medicated topical therapy
- Conditions
- Moderate to severe atopic dermatitisMedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2018-003804-37-IT
- Lead Sponsor
- PFIZER INC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 285
1. Participant must be 12 to<18 years of age, inclusive, at the time of signing the informed consent.
Type of Participant and Disease Characteristics
2. Participants who meet the following AD criteria:
• Clinical diagnosis of chronic moderate to severe AD (also known as atopic eczema) for at least 1 year prior to Day 1 and has confirmed AD at the screening and baseline visits according to Hanafin and Rajka criteria for AD.
• Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with medicated topical therapy for AD for at least 4 weeks or who have required systemic therapies for control of their disease.
NOTE: Medicated topical therapy is defined as a topical product that contains an active pharmaceutical ingredient indicated for the treatment of AD (irrespective of whether it is an over-the-counter [OTC] or prescribed product).
• Moderate to severe AD (affected BSA greater than or equal 10%, IGA greater than or equal 3, EASI greater than or equal16, Peak Pruritus NRS greater than or equal 4 at the baseline visit).
3. During the last 7 days prior to Day 1, for the treatment of AD, the subject must have used only non-medicated topical therapy (ie, emollient) at least twice daily, without other active ingredients indicated to treat AD, or other additives which could affect AD (eg, hyaluronic acid, urea, ceramide or filaggrin degradation products), with response to treatment remaining inadequate at baseline. The participant must also be willing and able to comply with standardized background topical therapy, as per protocol guidelines, throughout the remainder of the
study.
4. Must agree to avoid prolonged exposure to the sun and not to use tanning booths, sun lamps or other ultraviolet light sources during the study.
5. If receiving concomitant medications for any reason other than AD, must be on a stable regimen, which is defined as not starting a new drug or changing dosage within 7 days or 5 half lives (whichever is longer) prior to Day 1 and through the duration of the study.
6. Body weight >=40 kg. The body weight threshold may be revised after interim PK data from adolescents in study B7451012 have been evaluated by the E DMC. Study sites will be notified of the revised body weight threshold, if applicable.
7. Male or Female
Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
a. Male participants: No contraceptive measures required.
b. Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
• Is not a woman of childbearing potential (WOCBP)
OR
• Is a WOCBP (all female participants, regardless of whether or not they have experienced/reported menarche, are considered WOCBP unless they are permanently sterile or confirmed infertile). A WOCBP who is sexually active must use a contraceptive method that is highly effective, with a failure rate of <1%, as described in Appendix 4 during the intervention period and for at least 28 days after the last dose of study intervention. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
(…)
For full list of Principal Exclusion Criteria, please refer to Protocol.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adult
Medical Conditions
1. Other acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or study intervention administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
2. Any psychiatric condition including recent or active suicidal ideation or behavior that meets any of the criteria listed in the study protocol.
3. A current or past medical history of conditions associated with thrombocytopenia, coagulopathy or platelet dysfunction.
4. Currently have active forms of other inflammatory skin diseases, ie, not AD or have evidence of skin conditions at the time of Day 1 that would interfere with evaluation of AD or response to treatment.
5. Have a history of any lymphoproliferative disorder such as Epstein Barr virus (EBV)-related lymphoproliferative disorder, history of lymphoma, leukemia, or signs or symptoms suggestive of current lymphatic or lymphoid disease.
6. Infection History as indicated in the study protocol.
7. Have a history of alcohol or substance abuse within 6 months prior to Day 1 that in the opinion of the investigator will preclude participation in the study.
8. Have a known immunodeficiency disorder or a first degree relative with a hereditary immunodeficiency.
9. Have any malignancies or have a history of malignancies with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ.
10. Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) as evidenced by any of the listed in the protocol.
Prior/Concomitant Therapy
11. Require treatment with prohibited concomitant medication(s) or have received a prohibited concomitant medication within the specified time frame prior to the first dose of study medication.
12. Receiving anti coagulants or medications known to cause thrombocytopenia, (unless considered safe to stop and washout for the duration of the study).
13. Vaccinated or exposed to a live or attenuated vaccine within the 6 weeks prior to the first dose of study intervention, or is expected to be vaccinated or to have household exposure to these vaccines during
treatment or during the 6 weeks following discontinuation of study intervention.
14. Participants without documented evidence of having received at least one dose of the varicella vaccine in countries where the vaccine is approved and standard of care or those who do not have evidence of
prior exposure to varicella zoster virus (VZV) based on serological testing (ie, varicella zoster virus immunoglobulin G antibody [VZV IgG Ab]) at screening.
15. Participants who have received prior treatment with any JAK inhibitors.
16. Have received any of the following treatment regimens specified in the timeframes outlined below:
Within 1 year of first dose of study intervention:
• As indicated in the protocol
Within 12 weeks of first dose of study intervention:
• As indicated in the protocol
Within 4 weeks of first dose of study intervention:
• As indicated in the protocol
Within 1 week of first dose of study intervention:
• As indicated in the protocol
Prior/Concurrent Clinical Study Experience
17. Participation in other studies involving investigational drug(s) within 8 weeks or within 5 half lives (if known) whichever is longer, prior to study entry and/or durin
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method