PF-06651600 for Alopecia Areata

(ALLEGRO-LT Trial)

Not currently recruiting at 199 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, PF-06651600, for people with alopecia areata, a condition that causes hair loss. The goal is to determine the safety and effectiveness of this treatment for those affected. Participants who have lost at least 25% of their hair due to alopecia areata and haven't experienced regrowth in the last six months may qualify. Additionally, a sub-study examines how the treatment affects immune responses to certain vaccines. As a Phase 3 trial, this study is the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have taken other Janus kinase (JAK) inhibitors, you must have stopped them at least 12 weeks before the screening visit.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that PF-06651600, also known as ritlecitinib, is generally safe for people with alopecia areata. Studies have found that most patients can use it long-term without serious issues.

In one study, people with significant hair loss saw good results from this treatment. They mostly experienced mild to moderate side effects, such as headaches and colds, which are common with many treatments.

Additionally, earlier research did not find any major safety problems, suggesting the treatment is safe for most people. However, discussing any potential risks with a doctor is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for alopecia areata?

Researchers are excited about PF-06651600 for alopecia areata because it targets the JAK-STAT signaling pathway, which plays a critical role in the immune response that leads to hair loss. Unlike current treatments like corticosteroids or minoxidil, which often provide limited results, PF-06651600 offers a novel mechanism of action by directly interfering with the immune process responsible for attacking hair follicles. Additionally, this treatment is administered orally with a straightforward daily regimen, potentially offering a more convenient option compared to other therapies that might require topical application or injections.

What evidence suggests that PF-06651600 might be an effective treatment for alopecia areata?

Research shows that PF-06651600, also known as ritlecitinib, may help treat alopecia areata, a condition that causes hair loss. In earlier studies, people with significant scalp hair loss who took ritlecitinib experienced noticeable hair regrowth. One study found that this treatment remained effective for 48 weeks, suggesting lasting benefits. Additionally, the treatment proved safe for long-term use. Participants in this trial will receive PF-06651600, and evidence suggests that ritlecitinib could be a good option for those dealing with alopecia areata. ^{3 4 6 7 8}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39846397/

Long-term safety and efficacy of ritlecitinib in adults ... In patients with AA and ≥25% scalp hair loss, ritlecitinib demonstrated clinical efficacy and had an acceptable safety profile with long-term treatment.

2. jaad.org jaad.org/article/S0190-9622(22)01297-X/fulltext

33183 Efficacy of the oral JAK3/TEC inhibitor ritlecitinib (PF ... Conclusion: Ritlecitinib demonstrated sustained efficacy over 48 weeks in patients with AA with ≥50% scalp hair loss. Article metrics. Related Articles.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03732807

PF-06651600 for the Treatment of Alopecia Areata 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 ...

4. pfizer.com pfizer.com/news/press-release/press-release-detail/pfizer_presents_positive_phase_2_data_in_alopecia_areata_during_late_breaker_session_at_the_27th_european_academy_of_dermatology_and_venereology_eadv_congress

Pfizer Presents Positive Phase 2 Data in Alopecia Areata ... This Phase 2a, randomized, double-blind, multicenter study evaluates the efficacy, safety, and tolerability of PF-06651600 and PF-06700841 compared to placebo.

5. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2023/215830Orig1s000MultidisciplineR.pdf

215830Orig1s000 MULTI-DISCIPLINE REVIEW Summary ... The applicant provided substantial evidence of effectiveness for ritlecitinib 50 mg in the treatment of severe alopecia areata. This was ...

6. litfulo.pfizerpro.com litfulo.pfizerpro.com/safety/pooled-safety-data

Pooled Safety Data Placebo-controlled safety study of ritlecitinib (PF-06651600) in adults with alopecia areata. ClinicalTrials.gov identifier: NCT04517864. Updated December ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04517864

Study Details | NCT04517864 | PLACEBO-CONTROLLED ... Also called a data safety and monitoring board, or DSMB. Early Phase 1 ... SAFETY OF RITLECITINIB (PF-06651600) IN ADULT PARTICIPANTS WITH ALOPECIA AREATA.

8. jaad.org jaad.org/article/S0190-9622(22)01507-9/fulltext

33182 Safety of the oral JAK3/TEC inhibitor ritlecitinib (PF ... 33182 Safety of the oral JAK3/TEC inhibitor ritlecitinib (PF-06651600) in patients with alopecia areata: Results from the ALLEGRO phase 2b/3, randomized, double ...