PF-06651600 for Alopecia Areata

(ALLEGRO-LT Trial)

Recruiting at 164 trial locations

Overseen By Pfizer CT.gov Call Center

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Pfizer

Must not be taking: JAK inhibitors

Disqualifiers: Hearing loss, Malignancies, Herpes, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 60 months

1052 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a global Phase 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 alopecia areata. Eligible patients from the prior studies B7931005 (NCT02974868) and B7981015 (NCT03732807) will have an opportunity to enroll as well as patients who have not previously participated in either of these studies. The study is open-label and all patients entering the study will receive active study drug. A sub-study of approximately 60 adult patients who are participating in the B7981032 study will be conducted at select sites in the US, Australia and Canada. The sub-study will evaluate the immune response to tetanus and meningococcal vaccines in patients who have received a minimum of 6 months of 50 mg PF-06651600.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

This trial is for adults and adolescents (12 years and older) with alopecia areata, including severe forms like totalis and universalis. It's open to new participants with significant hair loss due to alopecia that started within the last 10 years, as well as those from prior related studies. People can't join if they have certain ear conditions, a history of some cancers or herpes infections, or recent serious infections.

Inclusion Criteria

I haven't seen any new hair growth on my scalp in the last 6 months.

I am 18 or older with significant hair loss from alopecia, including total or universal types.

I am between 12 and 18 years old with more than half of my scalp hair lost due to alopecia.

Exclusion Criteria

I last took a JAK inhibitor (not PF-06651600) more than 12 weeks ago.

I have no cancer history except for treated skin cancer or cervical pre-cancer.

I haven't been hospitalized or needed IV antibiotics in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 200 mg PF-06651600 daily for 1 month, followed by 50 mg daily for 59 months

60 months

Vaccine Sub-study

Evaluation of immune response to tetanus and meningococcal vaccines in patients after a minimum of 6 months of treatment

1 month

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine
• PF-06651600
• Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine

Trial Overview The study tests PF-06651600's safety and effectiveness in treating alopecia areata. All participants will receive this drug. A sub-study evaluates immune responses to tetanus and meningococcal vaccines in patients treated with PF-06651600 for at least six months.

Participant Groups

Group I: Treatment sequence 2 Experimental Treatment 3 Interventions

Participants who previously received study intervention in either study B7931005 or B7981015 will receive 50 mg PF-06651600 tablet or capsule given QD for 59 months. Patients participating in the vaccine sub-study will receive the 2 vaccines or 1 of the 2 vaccines at the vaccine sub-study Day 1, which will occur at a scheduled study visit on or after the Month 6 visit and prior to or on the Month 56 visit of the main B7981032 study.

Group II: Treatment sequence 1 Experimental Treatment 3 Interventions

Participants who did not previously receive study intervention in either study B7931005 or B7981015 will receive 200 milligrams (mg) PF-06651600, given as four 50 mg tablets once daily (QD) for 1 month, followed by 50 mg PF-06651600 tablet or capsule given QD for 59 months. Patients participating in the vaccine sub-study will receive the 2 vaccines or one of the 2 vaccines at the vaccine sub-study Day 1, which will occur at a scheduled study visit on or after the Month 9 visit and prior to or on the Month 56 visit of the main B7981032 study.

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University