Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Subjects With Alopecia Areata

Pfizer

Status and phase: Completed; Phase 2

Conditions: Alopecia Areata

Treatments: Drug: PF-06700841; Drug: Placebo; Drug: PF-06651600

Study type: Interventional

Funder types: Industry

Identifiers

NCT02974868

ALLEGRO (Other Identifier)

2016-004048-13 (EudraCT Number)

B7931005

Details and patient eligibility

About

This is a Phase 2a, randomized, double blind, parallel group, multicenter study with an extension period. The study will have a maximum duration of approximately 113 weeks. This includes an up to 5 weeks Screening Period, a 24 week Treatment Period, a 4 week Drug Holiday (#1), an up to 12 month Single Blind (investigator open, sponsor open and subject blind) Extension Period, a 4 week drug holiday (#2), a 6 month Cross Over Open Label Extension Period and a 4 week Follow up Period.

Enrollment: 142 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 moderate to severe alopecia areata:

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 2 week of first dose of study drug: Topical treatments that could affect AA; Herbal medications with unknown properties or known beneficial effects for AA.

Trial design

142 participants in 3 patient groups, including a placebo group

Cohort 1

Experimental group

Description:

PF-06651600

Treatment:

Drug: PF-06651600

Cohort 2

Experimental group

Description:

PF-06700841

Treatment:

Drug: PF-06700841

Cohort placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Placebo