A Phase 2b, multicenter, randomized, double-blind, vehicle controlled, parallel group dose ranging study to assess efficacy, safety, tolerability and pharmacokinetics of PF-06700841 cream in participants with mild or moderate atopic dermatitis

Phase 1

• Conditions: Atopic Dermatitis (AD); MedDRA version: 20.0 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2018-003050-24-PL
• Lead Sponsor: Pfizer Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-10
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 280

Inclusion Criteria

1. Female and Male participants between the ages of 18 and 75 years at the start of the study
1.a. Males participants between the ages 12 and 75, after 1st IRC review of unblinded data.
2. Have a clinical diagnosis of atopic dermatitis for at least 3 months
3. Have an Investigator’s Global Assessment (IGA) score of 2 (mild) or 3 (moderate)
4. Have an Eczema Area and Severity Index (EASI) total score of greater than or equal to 3 to less than or equal to 21
5. Have Peak Pruritus - Numerical Rating Scale (PP-NRS) of Grade greater than or equal to 2, at Day 1.

See section 5.1 of the Protocol for a full list of Inclusion Criteria
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 235
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

1. Other dermatological diseases (psoriasis) and infections that would interfere with evaluation of atopic dermatitis or response to treatment
2. Any history or recent psychiatric condition including recent or active suicidal ideation or behaviour
3. A history (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster
4. A history of skin infection requiring hospitalization, parenteral antimicrobial or antifungals therapy
5. Infected with Mycobacterium tuberculosis (TB)
6. Infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C viruses.

See section 5.2 of the Protocol for a full list of Exclusion Criteria

Study & Design

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