A PHASE 2B RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL, MULTICENTER, DOSE-RANGING, STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-04965842 IN SUBJECTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS.

Phase 1

Active, not recruiting

• Conditions: ATOPIC DERMATITIS; MedDRA version: 19.0Level: SOCClassification code 10021428Term: Immune system disordersSystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2015-005513-72-DE
• Lead Sponsor: Pfizer Inc, 235 East 42nd Street, New York, NY 10017

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-29
• Last Update Posted: 2017-12-11

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

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 between 18-75 years of age, inclusive, at time of informed consent.
3. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
4. Male subjects able to father children and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception (per Section 4.4.2) throughout the study and for at least 28 days after the last dose of assigned treatment.
Female subjects who are not of childbearing potential (eg, 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; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the post-menopausal state.
5. Must have the following atopic dermatitis criteria:
a. Have a 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 (Hanifin and Rajka criteria of AD refer to Appendix 2) at the Screening visit.
b. Have inadequate response to treatment with topical medications given for at least 4 weeks, or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks) within 12 months of the first dose of study drug.
c. Moderate to severe AD (affected BSA >=10 %, IGA >=3, and EASI >=12 at the screening and baseline visits).
6. 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.
7. 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. Subject must be willing to stay on a stable regimen during the duration of the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

(For more and complete information please refer to Protocol section 4.2)
1. Severe acute or chronic medical or psychiatric condition or laboratory abnormality.
...
4. Have received any of the following treatment regiments specified in the timeframes outlined below:
• Within 6 months of first dose of study drug: Any cell-depleting agents including but not limited to rituximab.
• Within 12 weeks of first dose of study drug: A) Any studies with JAK inhibitors. B) Other biologics: within 12 weeks of first dose of study drug or 5 half-lives (if known), whichever is longer.
• Within 8 weeks of first dose of study drug: Participation in other studies involving investigational drug(s) within 8 weeks of first dose of study drug or within 5 half-lives (if known), whichever is longer.
• Within 6 weeks of first dose of study drug: Have been vaccinated with live or attenuated live vaccine.
• Within 4 weeks of first dose of study drug: A) Use of oral immune suppressants within 4 weeks of first dose of study drug or within 5 half-lives (if known), whichever is longer. B) Phototherapy (NB-UVB) or broad band phototherapy. C) Regular use (more than 2 visits per week) of a tanning booth/parlor.
• Within 1 week of first dose of study drug: A) Topical treatments that could affect atopic dermatitis. Note: Corticosteroid inhalers and intranasal sprays are allowed for stable asthma patients. B) Herbal medications with unknown properties or known beneficial effects for AD.
...
17. History of human immunodeficiency virus (HIV) or positive HIV serology at screening,
18. Infected with hepatitis B or hepatitis C viruses.
19. Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) as defined by the following:
a. A positive QuantiFERON®-TB Gold (QFT-G) In-Tube test or positive Mantoux/Purified Protein Derivative (PPD) tuberculin skin test performed at or within the 12 weeks prior to Day 1 is exclusionary; a negative test is required for eligibility. It is recommended that subjects with a history of Bacille Calmette Guérin (BCG) vaccination be tested with the QFT-G test since the Mantoux/PPD tuberculin skin test may be positive due to vaccination. See Section 7.3.5 for requirements for Mantoux/PPD tuberculin skin testing. A QFT-G or Mantoux/PPD tuberculin skin test is not required if the subject has previously received a documented adequate course of therapy for either latent or active TB infection or is currently receiving a documented adequate treatment for latent TB infection;
b. A history of either untreated or inadequately treated latent or active TB infection;
c. If a subject has previously received an adequate course of therapy for either latent (9 months of isoniazid in a locale where rates of primary multi-drug TB resistance are <5% or an acceptable alternative regimen) or active (acceptable multi-drug regimen) TB infection, neither a QFT-G test nor a Mantoux/PPD tuberculin skin test is needed, but a chest radiograph(s) (per local standard/guidelines) must be obtained if not performed within 12 weeks prior to Day 1. To be considered eligible for the study, the radiograph(s) must be negative for active tuberculosis infection as determined by a qualified radiologist. Documentation of adequate treatment for TB and negative chest radiograph(s) results must be obtained prior to Day 1. If the current incidence rates of multi-drug resistant TB infection in the locale are unavailable, an adequate treat

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified