Ritlecitinib for Alopecia Areata

(ALLEGRO-100 Trial)

Recruiting at 21 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

Trial Summary

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.

What data supports the effectiveness of the drug Ritlecitinib for treating alopecia areata?

Research shows that Ritlecitinib has demonstrated effectiveness in treating alopecia areata, as seen in the ALLEGRO phase 2b/3 study, where it helped improve hair regrowth in patients. However, some patients who did not respond well to Ritlecitinib showed improvement after switching to another treatment, brepocitinib, suggesting that while Ritlecitinib can be effective, it may not work for everyone. ^{1 2 3 4 5}

Is ritlecitinib safe for humans?

Ritlecitinib has been studied for safety in people with alopecia areata, and common mild to moderate side effects include headache, sore throat, and upper respiratory infections. It has been approved for use in the USA and Japan, indicating it has met safety standards in these countries. ^{1 3 4 6 7}

How is the drug ritlecitinib unique for treating alopecia areata?

Ritlecitinib is unique because it is an oral medication that specifically targets and inhibits certain enzymes (JAK3 and TEC family kinases) involved in the immune response that attacks hair follicles, which is different from other treatments that may not target these specific pathways. ^{1 2 4 6 7}

What is the purpose of this trial?

The purpose of the study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the treatment of alopecia areata. Alopecia areata is a disease that causes hair loss on the scalp, face, and areas of the body. Ritlecitinib is approved in many countries at a dose of 50 mg (milligram) taken by mouth once a day for the treatment of patients 12 years and older with severe alopecia areata. This study will look at both the 50 mg dose and a 100 mg dose. This study is seeking participants who: * Are 12 years of age or older * Have a diagnosis of alopecia areata * Have lost 50% or more of the hair on their scalp * Do not have any other conditions that causes hair loss * Are willing to stop all other treatments that they may be taking for alopecia areata About 550 participants will take part in in this study. Participants will be chosen by chance, like drawing names out of a hat, to receive 1 of 2 different amounts of ritlecitinib (50 mg and 100 mg) taken by mouth once daily. The 2 doses of ritlecitinib in this study will be compared to each other and also to data from previous studies. This will help to see if the 100 mg dose of ritlecitinib is safe and effective. People will be in this study for about 13 months. During the study, participants will need to visit the study site up to 9 times. Participants will undergo various tests and procedures such as: * alopecia areata assessment, * physical examinations, * hearing tests, * blood tests, * x-ray, * ECG (electrocardiogram), * photographs of the scalp and eyes. Participants will also be asked to complete questionnaires about their alopecia areata.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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 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]

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, 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]

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]

References

1. England 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. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Ritlecitinib and Brepocitinib in Alopecia Areata: Results from the Crossover Open-Label Extension of the ALLEGRO Phase 2a Trial. [2023]

3. Switzerland 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. [2023]

4. England 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. [2022]

5. United States 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. [2023]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Ritlecitinib: First Approval. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

LITFULOTM (Ritlecitinib) Capsules: A Janus Kinase 3 Inhibitor for the Treatment of Severe Alopecia Areata. [2023]