PF-06651600 for the Treatment of Alopecia Areata (ALLEGRO-2b/3)

Pfizer

Status and phase: Completed; Phase 3; Phase 2

Conditions: Alopecia Areata

Treatments: Drug: PF-06651600 Induction Dose; Drug: PF-06651600 Maintenance Dose #3; Drug: PF-06651600 Maintenance Dose #1; Drug: PF-06651600 Maintenance Dose #2; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03732807

B7981015

2018-001714-14 (EudraCT Number)

ALLEGRO 2B/3 (Other Identifier)

Details and patient eligibility

About

This is a global Phase 2b/3 study to evaluate the safety and effectiveness of an investigational study drug (called PF-06651600) in adults and adolescents (12 years and older) who have 50% or greater scalp hair loss. The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). This is a dose-ranging study, investigating 5 different dosing regimens. It will be double-blinded, meaning that the sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.

Enrollment: 718 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of alopecia areata with no other cause of hair loss
• ≥50% hair loss of the scalp, including alopecia totalis and alopecia universalis, without evidence of terminal hair regrowth within 6 months
• Current episode of hair loss ≤10 years

Exclusion criteria

• Other types of alopecia or other diseases that can cause hair loss
• Other scalp diseases that could interfere with assessment of hair loss/regrowth
• Subjects with shaved heads must not enter the study until hair has grown back & is considered stable by the investigator
• Any previous use of any Janus kinase (JAK) inhibitor

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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718 participants in 7 patient groups

Sequence A

Experimental group

Description:

Induction dose given once daily (QD) for 4 weeks followed by maintenance dose #1 given QD for 44 weeks

Treatment:

Drug: PF-06651600 Induction Dose

Drug: PF-06651600 Maintenance Dose #1

Sequence B

Experimental group

Description:

Induction dose given QD for 4 weeks followed by maintenance dose #2 given QD for 44 weeks

Treatment:

Drug: PF-06651600 Induction Dose

Drug: PF-06651600 Maintenance Dose #2

Sequence C

Experimental group

Description:

Maintenance dose #1 given QD for 48 weeks

Treatment:

Drug: PF-06651600 Maintenance Dose #1

Sequence D

Experimental group

Description:

Maintenance dose #2 given QD for 48 weeks

Treatment:

Drug: PF-06651600 Maintenance Dose #2

Sequence E

Experimental group

Description:

Maintenance dose #3 given QD for 48 weeks

Treatment:

Drug: PF-06651600 Maintenance Dose #3

Sequence F

Experimental group

Description:

Placebo given QD for 24 weeks followed by induction dose given QD for 4 weeks then maintenance dose #1 given QD for 20 weeks

Treatment:

Drug: PF-06651600 Induction Dose

Drug: PF-06651600 Maintenance Dose #1

Drug: Placebo

Sequence G

Experimental group

Description:

Placebo given QD for 24 weeks followed by maintenance dose #1 given QD for 24 weeks

Treatment:

Drug: PF-06651600 Maintenance Dose #1

Drug: Placebo