140 Participants Needed

Ritlecitinib for Alopecia Areata

(B7981028 Trial)

Recruiting at 3 trial locations
Age: < 18
Sex: Any
Trial Phase: Phase 3
Sponsor: Pfizer
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the long-term safety and effects of ritlecitinib, a new treatment for severe alopecia areata, a condition that causes significant hair loss. Participants will take a ritlecitinib capsule once daily at home to determine its effectiveness in addressing hair loss over a period of up to three years. The trial is open to individuals who have previously participated in specific Pfizer studies for alopecia areata and have lost at least half of their scalp hair due to the condition. Regular clinic visits and phone check-ins will monitor participants' progress. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that ritlecitinib is likely to be safe for humans?

Research has shown that ritlecitinib is generally safe for people with alopecia areata, a condition that causes hair loss. In studies, most patients did not experience serious side effects. A combined safety review found that ritlecitinib is safe for use for up to 24 months in individuals aged 12 and older.

Ritlecitinib has already received FDA approval for treating severe alopecia areata in people aged 12 and up, indicating that the drug's safety has been thoroughly evaluated. While any treatment can have side effects, evidence so far suggests that ritlecitinib is a safe option for managing alopecia areata.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for alopecia areata, which often involve corticosteroids or immunosuppressants, Ritlecitinib is a promising new option because it targets specific pathways involved in the autoimmune process. Ritlecitinib is a Janus kinase (JAK) inhibitor, which means it works by blocking certain enzymes that contribute to inflammation and immune responses that attack hair follicles. This targeted mechanism could potentially offer a more effective and precise approach to treating alopecia, minimizing the broader side effects associated with traditional immunosuppressive therapies. Researchers are excited about Ritlecitinib because it represents a more focused strategy that could improve hair regrowth and quality of life for patients.

What evidence suggests that ritlecitinib might be an effective treatment for alopecia areata?

Research has shown that ritlecitinib offers promising results for people with alopecia areata, a condition that causes hair loss. In studies, patients who lost at least 25% of their scalp hair experienced significant regrowth with ritlecitinib over time. By week 12 of treatment, about 31.9% of patients with severe hair loss noticed a substantial improvement. In this trial, participants will receive either a higher dose or a lower dose of ritlecitinib. Ritlecitinib not only promotes hair regrowth but also reduces the emotional stress associated with alopecia areata. The treatment has proven to be both effective and safe for long-term use.678910

Who Is on the Research Team?

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for children with severe alopecia areata who have finished a previous Pfizer study (B7981027 or B7981031). They should have significant hair loss and must have had varicella vaccination or immunity. The trial involves taking ritlecitinib, an oral medication, daily for up to 3 years.

Inclusion Criteria

I have alopecia areata and finished studies B7981027 or B7981031.
I have lost more than half of my scalp hair due to alopecia areata.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ritlecitinib (higher or lower dose) or placebo for up to 3 years

36 months
17 visits (in-person), monthly calls (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Ritlecitinib
Trial Overview Ritlecitinib's long-term safety and effectiveness in treating severe alopecia areata are being tested. Participants will either continue their previous dose from the earlier study or start on a new dose. They'll visit the clinic 17 times and receive monthly calls over three years.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Ritlecitinib lower doseExperimental Treatment1 Intervention
Group II: Ritlecitinib higher doseExperimental Treatment1 Intervention

Find a Clinic Near You

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 profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.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.
Utilization and Effectiveness of Ritlecitinib in a Real-World ...The objective of the current study is to evaluate patient characteristics, treatment patterns and related clinical outcomes of patients who ...
Results with LITFULO® (ritlecitinib) | Safety InfoView study results and before-and-after photos of actual patients with severe alopecia areata and explore the safety and effectiveness of LITFULO® medication.
Real-world efficacy of ritlecitinib in treating alopecia areata ...By week 12, the SALT50 response rates were 61.9% in the mild-moderate group versus 31.9% in the severe group (P = .005), while the SALT80 response rates were ...
Ritlecitinib Shows Significant Reduction in Alopecia Areata ...Ritlecitinib significantly improves hair regrowth and reduces psychosocial burdens in patients with alopecia areata, enhancing emotional ...
Pooled Safety DataThe ALLEGRO-2a Study was a randomized, double-blind, placebo-controlled study that evaluated the safety and tolerability of LITFULO in adults 18 to ≤50 years of ...
7.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38263353/
Integrated Safety Analysis of Ritlecitinib, an Oral JAK3/TEC ...Conclusions: Ritlecitinib is well tolerated with an acceptable safety profile up to 24 months in patients aged ≥ 12 years with AA (video ...
Study Details | NCT04517864 | PLACEBO-CONTROLLED ...This is a global Phase 2a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of ritlecitinib in adults aged 18 to ...
integrated analysis of the ALLEGRO phase IIb/III and long ...Around 8 out of 10 people were satisfied with their hair growth after 2 years, and the safety of ritlecitinib was as expected from the studies ...
10.litfulo.comlitfulo.com/
Home Page | LITFULO® (ritlecitinib) | Safety InfoLITFULO is the first and only FDA-approved, once-daily pill for adults, teens, and tweens ages 12+ with severe alopecia areata. Watch full video. In just under ...
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