A Study to Determine the Efficacy and Safety of PF-04965842 & Dupilumab in Adult Patients with Atopic Dermatitis
- Conditions
- Moderate to severe atopic dermatitis (AD)MedDRA version: 20.0Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2018-002573-21-AT
- Lead Sponsor
- Pfizer Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 700
1. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
2. Male or female subjects aged 18 years or older at the time of informed consent.
3. Meet all the following atopic dermatitis criteria:
• Clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 1 year prior to Day 1 and has confirmed atopic dermatitis at the screening and baseline visits according to Hanifin and Rajka criteria for AD17 (see Appendix 2).
• 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 body surface area (BSA) = 10%, IGA = 3, EASI = 16, and Pruritus NRS severity score = 4 on the day of the baseline visit).
4. 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) without other active ingredients indicated to treat AD, or other additives which could affect AD (eg, hyaluronic acid, urea, ceramide or filaggrin degradation products) at least twice daily, with response to treatment remaining inadequate at baseline. The subject must also be willing and able to comply with standardized background topical therapy, as per protocol guidelines (Section 5.8.1), throughout the remainder of the study.
5. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
6. Female subjects who are of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:
a. Female subjects of childbearing potential must have a confirmed negative pregnancy test prior to randomization;
b. Female subjects of childbearing potential must agree to use a highly effective method of contraception (as per Section 4.4.1) for the duration of the active treatment period and for at least 28 days after the last dose of investigational product.
NOTE: Sexual abstinence, defined as completely and persistently refraining from all heterosexual intercourse (including during the entire period of risk associated with study treatments) may obviate the need for contraception ONLY if this is the preferred and usual lifestyle of the subject.
7. Female subjects of non childbearing potential must meet at least 1 of the following criteria:
• Have undergone a documented hysterectomy and/or bilateral oophorectomy;
• Have medically confirmed ovarian failure; or
• Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.
All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.
8. 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.
9. If receiving concomitant medications
1. 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.
2. Any psychiatric condition including recent or active suicidal ideation or behavior that meets any of the following criteria:
• Suicidal ideation associated with actual intent and a method or plan in the past year: Yes” answers on items 4 or 5 of the Columbia suicide severity rating scale (C SSRS) (Appendix 15);
• Previous history of suicidal behaviors in the past 5 years: Yes” answer (for events that occurred in the past 5 years) to any of the suicidal behavior items of the C-SSRS;
• Any lifetime history of serious or recurrent suicidal behavior;
• Clinically significant depression: patient health questionnaire – 8 items (PHQ 8) total score = 15 (Appendix 16);
• The presence of any current major psychiatric disorder that is not explicitly permitted in the inclusion/exclusion criteria;
• In the opinion of the investigator or Pfizer (or designee) exclusion is required.
3. A current or past medical history of conditions associated with thrombocytopenia, coagulopathy or platelet dysfunction.
4. Receiving anti coagulants or medications known to cause thrombocytopenia, (unless considered safe to stop and washout for the duration of the study).
5. Currently have active forms of other inflammatory skin diseases, ie, not AD or have evidence of skin conditions (eg, psoriasis, seborrheic dermatitis, Lupus) at the time of Day 1 that would interfere with evaluation of atopic dermatitis or response to treatment.
6. Vaccinated or exposed to a live or attenuated vaccine within the 6 weeks prior to the first dose of investigational product, or is expected to be vaccinated or to have household exposure to these vaccines during treatment or during the 6 weeks following discontinuation of investigational product.
7. Subjects who have received prior treatment with any JAK inhibitors.
8. Previous treatment with dupilumab and/or a history of hypersensitivity, intolerance, adverse event, or allergic reaction associated with prior exposure to dupilumab’s excipients.
9. 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 during study participation.
NOTE: Any investigational or experimental therapy taken or procedure performed for AD, psoriasis, psoriatic arthritis or rheumatoid arthritis in the previous 1 year should be discussed with the Pfizer Medical Monitor (or designee). Subjects cannot participate in studies of other investigational or experimental therapies or procedures at any time during their participation in this study.
10. Have received any treatment regimens specified in the timeframes outlined in the protocol (secton 4.2)
11. 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.
12. Infection history (please refer to protocol section 4.2)
13. Have a history of alcohol or substance abuse within 6 months prior to Day 1 t
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