Ritlecitinib for Baldness

(B7981027 Trial)

Recruiting at 17 trial locations

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Pfizer

Disqualifiers: Non-AA alopecia, Hearing loss, Malignancies, Depression, others

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: 10

Duration: 24 weeks

225 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine, ritlecitinib, for treating severe alopecia areata, a condition causing significant hair loss. The researchers aim to determine if ritlecitinib is safe and effective in promoting hair regrowth. Participants will receive either ritlecitinib at varying doses or a placebo (a pill with no active medicine) for comparison. Suitable candidates have lost at least half of their scalp hair due to alopecia areata and are either vaccinated against chickenpox or have had the infection. The study lasts six months, with regular clinic visits and phone calls to monitor 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 for alopecia areata.

Do I need to stop my current medications to join 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 well-tolerated by people with alopecia areata. In studies involving patients with significant hair loss, ritlecitinib produced positive results and remained safe for long-term use. A detailed safety review confirmed that the treatment's side effects aligned with earlier findings, revealing no new or unexpected side effects.

In a controlled study, participants taking ritlecitinib experienced no major safety issues compared to those taking a placebo (a non-active treatment). This suggests that the treatment is safe for people with alopecia areata. ^{1 2 3 4 5}

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

Most treatments for baldness, like minoxidil or finasteride, work by stimulating hair growth or blocking hormones that lead to hair loss. But Ritlecitinib works differently, targeting the JAK-STAT signaling pathway, which is involved in inflammation that can lead to hair loss. Researchers are excited about Ritlecitinib because it offers a novel approach, potentially leading to more effective results for people who haven’t responded well to existing treatments. Additionally, the treatment is available in a capsule form, making it easy to incorporate into daily routines.

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

Research has shown that ritlecitinib may help treat severe alopecia areata, a condition that causes hair loss. In earlier studies, 14% to 31% of patients experienced significant hair regrowth, with only 20% or less of their scalp still affected by hair loss. Another study found that almost one-third of patients achieved complete hair regrowth after three years of treatment. Ritlecitinib was generally well tolerated, with most people not experiencing serious side effects. This trial will evaluate different doses of ritlecitinib, with some participants receiving a higher dose and others a lower dose, to determine its effectiveness and safety. These findings suggest that ritlecitinib could be an effective option for those dealing with this condition. ^{1 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 children aged 6 to 12 with severe alopecia areata, which causes significant hair loss. Participants must have lost at least 50% of scalp hair and either had varicella (chickenpox) or been vaccinated against it. In the EU/UK, they should have tried other treatments without success.

Inclusion Criteria

I am in the EU/UK and treatments like creams, medications, or hairpieces for AA didn't work for me.

I have alopecia with over 50% scalp hair loss and no hair regrowth in the past year.

I have either been vaccinated against chickenpox or have antibodies showing I was exposed to it.

Exclusion Criteria

I have or had cancer or a disorder related to my lymphatic system.

My hair loss is not due to alopecia areata or a known congenital cause.

I have hearing loss before starting the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive ritlecitinib or placebo for 24 weeks

24 weeks

8 visits (in-person), 8 calls (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Long-term extension (optional)

Participants may opt into continuation of treatment long-term if eligibility criteria are met

What Are the Treatments Tested in This Trial?

Interventions

• Ritlecitinib

Trial Overview The study tests ritlecitinib's safety and effectiveness in treating severe alopecia areata. It compares two doses of ritlecitinib against a placebo over six months, with participants taking capsules daily at home and attending eight clinic visits while receiving phone calls from the study team.

How Is the Trial Designed?

Group I: Ritlecitinib lower dose Experimental Treatment 1 Intervention

Participants will receive 1 ritlecitinib lower dose capsule QD and 1 placebo higher dose capsule QD orally for 24 weeks.

Group II: Ritlecitinib higher dose Experimental Treatment 1 Intervention

Participants will receive 1 ritlecitinib higher dose capsule once a day (QD) and 1 placebo lower dose capsule once a day (QD) orally for 24 weeks.

Group III: Placebo Placebo Group 1 Intervention

Participants will receive 1 placebo higher dose capsule QD and 1 placebo lower dose capsule QD orally for 24 weeks.

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. thelancet.com thelancet.com/article/S0140-6736(23)00222-2/fulltext

Efficacy and safety of ritlecitinib in adults and adolescents ... In a placebo-controlled, phase 2a clinical trial, ritlecitinib was efficacious and generally well tolerated in adults with alopecia areata.

3. litfulo.com litfulo.com/get-to-know-litfulo/results-with-litfulo

Results with LITFULO® (ritlecitinib) | Safety Info View study results and before-and-after photos of actual patients with severe alopecia areata and explore the safety and effectiveness of LITFULO® medication.

4. naaf.org naaf.org/news/new-clinical-trial-data-published-for-ritlecitinib/

New Clinical Trial Data Published for Ritlecitinib Between 14% and 31% of patients in the different treatment groups reached the study endpoint, which was 20% or less scalp hair loss. In addition ...

5. healio.com healio.com/news/dermatology/20251023/complete-hair-regrowth-for-some-with-alopecia-after-3year-ritlecitinib-treatment

Complete hair regrowth for some with alopecia after 3-year ... Almost one-third of people treated for 3 years with ritlecitinib for alopecia areata achieved complete scalp hair regrowth, according to a study ...

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

Pooled Safety Data In the placebo-controlled period of clinical trials in alopecia areata, a total of 668 patients were exposed to LITFULO with 130 patients receiving LITFULO 50 ...

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

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 ...

8. skin.dermsquared.com skin.dermsquared.com/skin/article/view/3864

Updated Integrated Safety Analysis of Ritlecitinib Up to Conclusion Ritlecitinib was generally well tolerated ~5 years in patients with AA. Safety was consistent with previously reported data. Funding ...