Ritlecitinib for Alopecia Areata

(ALLEGRO-100 Trial)

Recruiting at 131 trial locations

Overseen By Pfizer CT.gov Call Center

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Pfizer

Must not be taking: Antibiotics, Antivirals, Antifungals, others

Disqualifiers: Other alopecia, Severe allergies, Infections, 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: 9

Duration: 48 weeks

550 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effects of ritlecitinib, a medicine for treating alopecia areata, a condition that causes hair loss on the scalp and body. It compares two doses, 50 mg and 100 mg taken by mouth once daily, to determine if the higher dose is safe and effective. The trial seeks participants who have lost at least 50% of their scalp hair due to alopecia areata and are willing to stop other treatments. Participants will engage in the study for about 13 months, with regular check-ins for assessments and tests. As a Phase 3 trial, this study represents 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 requires participants to stop all other treatments they may be taking for alopecia areata.

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

Research has shown that ritlecitinib is generally safe for people with alopecia areata. In studies with participants aged 12 and older, the treatment proved safe for up to 24 months, with most people not experiencing serious side effects during this period.

Ritlecitinib has already received approval in several countries at a 50 mg daily dose for severe alopecia areata, providing existing safety information to support its use. The current study examines both 50 mg and 100 mg doses to compare their safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for alopecia areata?

Ritlecitinib is unique because it targets the Janus kinase (JAK) pathway, which is a different approach from most current treatments for alopecia areata, like corticosteroids or other immunosuppressants. This pathway plays a crucial role in immune system signaling, which is often overactive in conditions like alopecia areata. By specifically inhibiting this pathway, Ritlecitinib may offer more effective control of the condition with potentially fewer side effects. Researchers are excited about its potential to provide a more targeted treatment option that could lead to better hair regrowth outcomes for patients.

What is the effectiveness track record for ritlecitinib in treating alopecia areata?

Research has shown that ritlecitinib effectively treats alopecia areata, a condition causing hair loss. In studies, individuals with significant hair loss experienced noticeable hair regrowth after using ritlecitinib. Specifically, by week 12, about 31.9% of those with severe alopecia had significant hair regrowth. This medication not only promotes hair regrowth but also alleviates the emotional and social challenges associated with hair loss. Participants in this trial will receive either 50 mg or 100 mg of ritlecitinib, with the possibility of re-randomization based on response. Ritlecitinib is already approved and used in many countries for severe cases, demonstrating its effectiveness and safety. ^{6 7 8 9 10}

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 people aged 12 and older with alopecia areata, a condition causing significant hair loss. Participants must have lost at least 50% of their scalp hair and not be undergoing other treatments for the condition. Adolescents can join if local regulations allow.

Inclusion Criteria

I have lost more than half of my scalp hair without regrowth in the last 6 months.

My current hair loss started less than 10 years ago.

I have been diagnosed with alopecia areata and no other cause for my hair loss.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 50 mg or 100 mg of ritlecitinib once daily for up to 48 weeks, with re-randomization at Week 24 based on response

48 weeks

Up to 9 visits (in-person)

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 The study tests two doses of Ritlecitinib (50 mg and 100 mg) taken daily by mouth against placebos to determine safety and effectiveness in treating severe alopecia areata. The results will also be compared to previous studies.

How Is the Trial Designed?

Group I: Ritlecitinib 50 mg Experimental Treatment 2 Interventions

Randomized to Ritlecitinib 50 mg QD for 24 weeks. Depending on response status at Week 24 (ie, whether the participant has a SALT score of less than or equal to 20), the participant may be re-randomized to Ritlecitinib 50 mg QD or Ritlecitinib 100 mg QD for another 24 weeks. In addition to the active Ritlecitinib 50 mg capsule, a placebo capsule matching the Ritlecitinib 100 mg capsule will be given in order to maintain the blind.

Group II: Ritlecitinib 100 mg Experimental Treatment 2 Interventions

Randomized to Ritlecitinib 100 mg QD for 48 weeks. In addition to the active Ritlecitinib 100 mg capsule, a placebo capsule matching the Ritlecitinib 50 mg capsule will be given in order to maintain the blind.

Group III: External Placebo Active Control 1 Intervention

This group will be constructed using participant-level data at Week 24 from placebo groups of the appropriately chosen Pfizer clinical studies of Ritlecitinib in participants with alopecia areata. This data will be used for comparison between each Ritlecitinib dose and placebo at Week 24. As this arm will utilize data from other studies, no participants will be randomized to receive only placebo in this study.

Group IV: Synthetic Placebo Active Control 1 Intervention

This group will be constructed using participant-level data up to Week 36 from the placebo groups of the appropriately chosen Pfizer clinical studies of Ritlecitinib in participants with alopecia areata and a longitudinal model and extrapolation. This data will be used for comparison between Ritlecitinib 100 mg and placebo at Week 36. As this arm will utilize data from other studies, no participants will be randomized to receive only placebo in this 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

Published Research Related to This Trial

Ritlecitinib, an oral kinase inhibitor developed by Pfizer, was approved in the USA on June 23, 2023, for treating severe alopecia areata in adults and adolescents aged 12 and older.

The drug has also received approval in Japan for intractable cases of alopecia areata and is undergoing regulatory review in the EU, UK, and China, indicating its potential as a significant treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ritlecitinib: First Approval. Blair, HA.[2023]

In the ALLEGRO phase 2b/3 study involving patients aged 12 and older with at least 50% scalp hair loss, ritlecitinib demonstrated significant efficacy in improving hair regrowth compared to placebo, regardless of distinct hair loss profiles identified at baseline.

Five distinct hair loss profiles were identified, and patients receiving ritlecitinib at doses of 30 mg or 50 mg were significantly more likely to report positive changes in hair growth and satisfaction with hair regrowth at 24 weeks, indicating the treatment's effectiveness across different types of alopecia areata.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hair Loss Profiles and Ritlecitinib Efficacy in Patients with Alopecia Areata: Post Hoc Analysis of the ALLEGRO Phase 2b/3 Study. Thaçi, D., Tziotzios, C., Ito, T., et al.[2023]

In a study involving 105 adolescents with alopecia areata, ritlecitinib showed significant efficacy, with 17%-28% achieving a SALT score of ≤20 (indicating minimal scalp hair loss) at 24 weeks, and 25%-50% at 48 weeks, compared to 0% in the placebo group.

Ritlecitinib was well-tolerated, with common side effects including headache and acne, but no serious adverse events like major cardiovascular issues or infections reported, indicating a favorable safety profile for this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of ritlecitinib in adolescents with alopecia areata: Results from the ALLEGRO phase 2b/3 randomized, double-blind, placebo-controlled trial. Hordinsky, M., Hebert, AA., Gooderham, M., et al.[2023]

Ritlecitinib (LITFULOTM) is an effective treatment for severe alopecia areata, achieving a significant reduction in hair loss as measured by the Severity of Alopecia Tool (SALT) score, with 31% of participants on the 200 mg dose achieving a SALT score of ≤20 after 24 weeks.

The treatment was generally well-tolerated, with mild to moderate side effects such as headache and upper respiratory infections, indicating a favorable safety profile for patients aged 12 and older.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LITFULOTM (Ritlecitinib) Capsules: A Janus Kinase 3 Inhibitor for the Treatment of Severe Alopecia Areata. Gupta, AK., Ravi, SP., Vincent, K., et al.[2023]

In a phase 2b-3 trial involving 718 patients with alopecia areata, ritlecitinib demonstrated significant efficacy, with response rates based on the Severity of Alopecia Tool (SALT) score showing a 29.1% higher response in the 200 mg + 50 mg group compared to placebo at week 24.

Ritlecitinib was well tolerated, with adverse events reported in 82% to 86% of patients across different dosage groups, but no deaths occurred, indicating it may be a safe treatment option for patients aged 12 and older.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b-3 trial. King, B., Zhang, X., Harcha, WG., et al.[2023]

In the phase 2a ALLEGRO trial involving 142 adults with alopecia areata, both ritlecitinib and brepocitinib significantly improved patient-reported outcomes (AASIS scores) and clinician-assessed hair loss (SALT scores) after 24 weeks compared to placebo.

The study found medium-to-large correlations between patient-reported outcomes and clinician assessments, indicating that both measures are important for evaluating treatment effectiveness in alopecia areata.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing the relationships between patient-reported outcomes and clinician assessments of alopecia areata in a phase 2a randomized trial of ritlecitinib and brepocitinib. Winnette, R., Banerjee, A., Sikirica, V., et al.[2022]

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. clinicaltrials.gov clinicaltrials.gov/study/NCT07226531

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 ...

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. sciencedirect.com sciencedirect.com/science/article/pii/S0190962225024600

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 ...

5. ajmc.com ajmc.com/view/ritlecitinib-shows-significant-reduction-in-alopecia-areata-psychosocial-burden

Ritlecitinib Shows Significant Reduction in Alopecia Areata ... Ritlecitinib significantly improves hair regrowth and reduces psychosocial burdens in patients with alopecia areata, enhancing emotional ...

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

Pooled Safety Data The 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.gov pubmed.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 ...

8. 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 ...

9. academic.oup.com academic.oup.com/bjd/article/192/2/215/7829168

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.com litfulo.com/

Home Page | LITFULO® (ritlecitinib) | Safety Info LITFULO 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 ...