Ritlecitinib for Vitiligo

(Tranquillo LTE Trial)

Recruiting at 94 trial locations

Overseen By Pfizer CT.gov Call Center

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Pfizer

Disqualifiers: Suicidal ideation, Lab abnormalities, 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: 52 weeks

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and effectiveness of ritlecitinib for individuals with non-segmental vitiligo, a skin condition that causes white patches. The research will assess whether repigmentation (return of skin color) remains stable, improves, or persists with different doses of ritlecitinib (a new potential drug) or a placebo (a pill with no active medicine). Participants who completed a previous 52-week study with ritlecitinib or placebo and have the condition may qualify. The trial involves taking capsules at home and attending study visits to monitor results. 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.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether 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 this trial's treatments are likely to be safe?

Research has shown that ritlecitinib is generally safe for people with non-segmental vitiligo. Specifically, studies found that patients who took ritlecitinib for 48 weeks experienced safety and effectiveness, with most not having serious side effects. Additionally, ritlecitinib 50 mg has already received approval for treating severe Alopecia Areata, a condition similar to vitiligo, in several countries, including the US, EU, and Japan. This approval indicates that the drug's safety is well-documented for conditions with similar immune system issues. ^{1 2 3 4 5}

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

Ritlecitinib is unique because it targets the Janus kinase 3 (JAK3) enzyme, which plays a crucial role in the immune system's signaling pathways. This is different from the standard treatments for vitiligo, like corticosteroids or calcineurin inhibitors, which primarily focus on reducing inflammation. By specifically inhibiting JAK3, ritlecitinib could potentially offer a more targeted approach, minimizing the immune system's attack on skin pigment cells. Researchers are excited about ritlecitinib because this targeted action may lead to more effective repigmentation with possibly fewer side effects compared to conventional therapies.

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

Research shows that ritlecitinib effectively treats non-segmental vitiligo. Studies have found that ritlecitinib aids in repigmentation, restoring color to the white patches of skin caused by vitiligo. Over 48 weeks, patients taking ritlecitinib experienced noticeable improvements, and the treatment was well-tolerated. In this trial, participants will receive either Ritlecitinib 50 mg, Ritlecitinib 100 mg, or a placebo. Ritlecitinib blocks certain enzymes that cause the immune system to attack skin pigment cells. This drug is already approved for treating severe alopecia areata, another condition where the immune system attacks the body. ^{1 2 5 6 7}

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 who have non-segmental vitiligo and participated in the previous study B7981040 for 52 weeks. They must start this study within 30 days after their last visit in the prior study.

Inclusion Criteria

I must start Study B7981041 within 30 days after completing week 52 of Study B7981040.

Participants who met the eligibility criteria and completed 52 weeks of study intervention for stable or active nonsegmental vitiligo in Study B7981040

Exclusion Criteria

Participant met the parent study (Study 7981040) discontinuation criteria or discontinued the parent study for any safety-related event

I do not have any active suicidal thoughts or behaviors, or any lab results that could make the study risky for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ritlecitinib 50 mg or 100 mg or placebo daily for up to 52 weeks

52 weeks

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

• Placebo
• Ritlecitinib
• Ritlecitinib 100 mg

Trial Overview The safety and effectiveness of Ritlecitinib, an oral medication, are being tested to see if it can maintain or improve skin repigmentation in patients with non-segmental vitiligo over a period of 52 weeks compared to a placebo.

How Is the Trial Designed?

Group I: Arm 2 Experimental Treatment 3 Interventions

Participants who previously received 1 placebo 50 mg capsule QD orally from BL to Week 52 in Study B7981040 Ritlecitinib 50 mg or Ritlecitinib 100 mg or Placebo will be assigned

Group II: Arm 1 Experimental Treatment 3 Interventions

Participants who previously received 1 ritlecitinib 50 mg capsule QD orally from BL to Week 52 in Study B7981040. Ritlecitinib 50 mg or Ritlecitinib 100 mg or Placebo will be assigned.

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

Topical ruxolitinib cream has been shown to significantly improve vitiligo symptoms, with 58% of patients achieving a 50% improvement in Vitiligo Area Scoring Index (VASI) after 52 weeks of treatment, making it an effective option for repigmentation.

The treatment has a favorable safety profile, with only mild adverse effects reported, such as erythema and pruritus, and it offers significant clinical improvements compared to traditional therapies, which may have more severe side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of Ruxolitinib for Treatment of Non-Segmental Vitiligo. Hwang, JR., Driscoll, MS.[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]

Ritlecitinib, an oral Janus kinase inhibitor, is being developed for multiple conditions including alopecia areata and rheumatoid arthritis, with data from 12 clinical trials involving healthy participants and patients collected between 2014 and 2021.

The development of a population pharmacokinetic model for ritlecitinib involved three iterations, leading to a final model that effectively addressed clinical drug development questions and informed the product label, indicating its potential efficacy and safety in various conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. Wojciechowski, J., S Purohit, V., Huh, Y., 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]

Topical tofacitinib, a Janus kinase (JAK) inhibitor, was used in combination with phototherapy for 9 months to treat an adolescent patient with long-standing and treatment-resistant vitiligo.

The treatment resulted in near complete repigmentation of the skin, suggesting that JAK inhibitors may be a promising therapy for vitiligo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical Tofacitinib: A Janus Kinase Inhibitor for the Treatment of Vitiligo in an Adolescent Patient. Berbert Ferreira, S., Berbert Ferreira, R., Neves Neto, AC., et al.[2021]

In a phase 2 trial involving patients with vitiligo, those using 1.5% ruxolitinib cream showed a significant improvement in facial Vitiligo Area Scoring Index scores, with a mean improvement of 79.9% at week 24 compared to only 1.1% in those who did not respond.

Proteomic analysis revealed distinct inflammatory biomarker profiles between patients who achieved at least a 50% improvement and those who did not, suggesting that these biomarkers could help identify which patients are more likely to benefit from ruxolitinib treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baseline Levels of Circulating Inflammatory Biomarkers Stratify Patients with Vitiligo Who Significantly Repigment after Treatment with Ruxolitinib Cream. Howell, MD., Kuo, FI., Rumberger, B., et al.[2023]

Combining low-dose tofacitinib with 308-nm excimer laser treatment shows promise as an effective therapy for patients with nonsegmental vitiligo who have not responded to standard treatments.

This combination therapy could offer a new option for patients struggling with vitiligo, potentially improving their skin condition when other therapies have failed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose tofacitinib with 308-nm excimer therapy successfully induced repigmentation in patients with refractory vitiligo. Fang, WC., Lin, SY., Huang, SM., et al.[2022]

In a phase 2 study involving 157 adults with vitiligo, ruxolitinib cream demonstrated significant efficacy, with 45% of patients using the 1.5% twice daily dose achieving at least a 50% improvement in facial vitiligo area by week 24, compared to only 3% in the control group.

The treatment was well tolerated, with most adverse events being mild to moderate, suggesting that ruxolitinib cream could be a safe and effective option for repigmentation in vitiligo patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ruxolitinib cream for treatment of vitiligo: a randomised, controlled, phase 2 trial. Rosmarin, D., Pandya, AG., Lebwohl, M., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36370907/

Efficacy and safety of oral ritlecitinib for the treatment ... Conclusions: Oral ritlecitinib was effective and well tolerated over 48 weeks in patients with active nonsegmental vitiligo. Keywords: JAK inhibitor; JAK/STAT ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0190962222029899

Efficacy and safety of oral ritlecitinib for the treatment ... Oral ritlecitinib was effective and well tolerated over 48 weeks in patients with active nonsegmental vitiligo.

3. jaad.org jaad.org/article/S0190-9622(22)01501-8/fulltext

33304 Ritlecitinib (PF-06651600), an oral JAK3/TEC ... Ritlecitinib 50 mg for up to 48 weeks, with or without a loading dose during the DR, showed efficacy in patients with active nonsegmental vitiligo and either ...

4. academic.oup.com academic.oup.com/bjd/article-abstract/188/Supplement_1/ljac106.004/6989781

Ritlecitinib (PF-06651600), an oral JAK3/TEC inhibitor, shows ... Ritlecitinib was generally safe with similar efficacy in vitiligo patients with lighter or darker FST. Issue Section: Abstracts.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05583526

A 52-Week Study of Ritlecitinib Oral Capsules in Adults ... A Phase 3 randomized, double-blind, 52-week placebo-controlled, multi center study investigating the efficacy, safety, and tolerability of ritlecitinib in ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06163326

NCT06163326 | A 52-Week Study to Learn About the ... This study is to evaluate how safe and effective ritlecitinib is in participants with non-segmental vitiligo (NSV).

7. pfizer.com pfizer.com/sites/default/files/plsr-studies/B7981019%20Plain%20Language%20Study%20Results%20Summary%20(PLSRS)%20Phase%202-4_0.pdf

Clinical Study Results Based on these results, the researchers have decided that the results are not likely the result of chance. Ritlecitinib may help to improve non ...