Study To Evaluate Pf-04965842 In Subjects With Moderate To Severe Atopic Dermatitis

Pfizer

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: PF-04965842; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02780167

B7451006

2015-005513-72 (EudraCT Number)

Details and patient eligibility

About

Study B7451006 is a Phase 2b POC study which is planned to assess four PF 04965842 once daily (QD) doses (10, 30, 100, 200 mg) relative to placebo over 12 weeks to characterize the efficacy and safety of PF 04965842 in subjects with moderate to severe AD. The objectives of the study are to demonstrate the efficacy of PF 04965842 by showing improvement in disease severity in patients with moderate to severe AD as measured by the Investigator's Global Assessment (IGA) and Eczema Area and Severity Index (EASI) scores, and safety to support further clinical development of PF 04965842.

Enrollment: 269 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female subjects between 18 75 years of age, inclusive, at time of informed consent.

• Must have the following atopic dermatitis criteria:

  1. 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.
  2. 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.
  3. Moderate to severe AD (affected BSA >=10 %, IGA >=3, and EASI >=12 at the screening and baseline visits).

Exclusion criteria

• History of human immunodeficiency virus (HIV) or positive HIV serology at screening,
• Infected with hepatitis B or hepatitis C viruses.
• Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
• 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 Within 12 weeks of first dose of study drug: Any studies with JAK inhibitors; Other biologics Within 8 weeks of first dose of study drug: Participation in other studies involving investigational drug(s) 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: Use of oral immune suppressants; Phototherapy (NB UVB) or broad band phototherapy; Regular use (more than 2 visits per week) of a tanning booth/parlor.

Within 1 week of first dose of study drug: Topical treatments that could affect atopic dermatitis; Herbal medications with unknown properties or known beneficial effects for AD.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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269 participants in 5 patient groups, including a placebo group

Cohort 1

Experimental group

Description:

10 mg of PF-04965842 QD

Treatment:

Drug: PF-04965842

Drug: PF-04965842

Drug: PF-04965842

Drug: PF-04965842

Cohort 2

Experimental group

Description:

30 mg of PF-04965842 QD

Treatment:

Drug: PF-04965842

Drug: PF-04965842

Drug: PF-04965842

Drug: PF-04965842

Cohort 3

Experimental group

Description:

100 mg of PF-04965842 QD

Treatment:

Drug: PF-04965842

Drug: PF-04965842

Drug: PF-04965842

Drug: PF-04965842

Cohort 4

Experimental group

Description:

200 mg of PF-04965842 QD

Treatment:

Drug: PF-04965842

Drug: PF-04965842

Drug: PF-04965842

Drug: PF-04965842

Cohort 5

Placebo Comparator group

Description:

placebo QD

Treatment:

Drug: Placebo