Ritlecitinib for Vitiligo

(Tranquillo Trial)

Recruiting at 142 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: Psychiatric conditions, Skin disorders, Infections, 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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

581 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a medication called ritlecitinib, which is taken as oral capsules. It aims to help adults and adolescents who have non-segmental vitiligo, a condition that causes skin to lose its color. The medication works by managing the immune system to stop the skin from losing its color.

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

You can continue taking your current medications as long as they are not for vitiligo and your regimen is stable, meaning no new drugs or dosage changes within 7 days or 5 half-lives before the trial starts. You must stop all other treatments for vitiligo during the trial.

Will I have to stop taking my current medications?

The trial requires that you stop all treatments for vitiligo, but you can continue taking other medications as long as you stay on a stable regimen (no changes in dosage or new medications) during the study.

What data supports the idea that Ritlecitinib for Vitiligo is an effective drug?

The available research does not provide specific data on the effectiveness of Ritlecitinib for Vitiligo. Instead, it highlights other treatments like ruxolitinib cream, tofacitinib, and baricitinib, which have shown positive results in repigmenting skin affected by vitiligo. These treatments are part of a group of drugs known as JAK inhibitors, which have been effective in treating vitiligo by helping the skin regain its color. ^{1 2 3 4 5}

What data supports the effectiveness of the drug Ritlecitinib for treating vitiligo?

Research on similar drugs, like ruxolitinib and tofacitinib, which are also JAK inhibitors, shows they can help repigment skin in vitiligo patients. This suggests that Ritlecitinib, being a JAK inhibitor, might also be effective for vitiligo. ^{1 2 3 4 5}

What safety data is available for Ritlecitinib?

Ritlecitinib, also known as LITFULO, has been evaluated for safety in clinical trials for alopecia areata. In a phase 2b-3 study, common mild to moderate adverse effects included headache, nasopharyngitis, and upper respiratory tract infection. This data is relevant as Ritlecitinib is also being developed for vitiligo. ^{1 6 7 8 9}

Is Ritlecitinib safe for humans?

Ritlecitinib has been tested in humans for conditions like alopecia areata, and common mild to moderate side effects include headache, sore throat, and upper respiratory infections. ^{1 6 7 8 9}

Is the drug Ritlecitinib a promising treatment for vitiligo?

Ritlecitinib is a promising drug because it is being developed for vitiligo and has already shown success in treating similar conditions like alopecia areata. It works by preventing the immune system from attacking the body's own cells, which is helpful in conditions like vitiligo where the immune system attacks skin cells. ^{1 3 6 7 9}

How is the drug Ritlecitinib unique for treating vitiligo?

Ritlecitinib is unique because it is an oral medication that works by inhibiting specific enzymes (Janus kinase 3 and tyrosine kinase) involved in the immune response, which may help prevent the immune system from attacking skin cells, potentially aiding in repigmentation for vitiligo patients. ^{1 3 6 7 9}

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

Adults and adolescents with vitiligo, both active (with at least one active lesion) and stable (no signs of disease progression), can join this study. Participants must have a certain amount of facial involvement and overall body surface area affected by vitiligo. Those under 18 may join in some regions if approved. People with skin conditions that could affect the trial or severe psychiatric issues, recent infections requiring hospitalization, or other health risks are excluded.

Inclusion Criteria

My vitiligo is either not changing or slowly getting worse.

I am 18 years or older, or between 12 and 17 with special approval outside the US.

I have trichrome lesions.

Exclusion Criteria

You have a medical or psychiatric condition that could make participating in the study potentially harmful for you or make you unsuitable for the study.

I have vitiligo or another skin condition.

I have been hospitalized or treated for a serious infection recently.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ritlecitinib or placebo for 52 weeks to assess efficacy, safety, and tolerability

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo
• Ritlecitinib

Trial Overview The trial is testing Ritlecitinib oral capsules for treating vitiligo over a period of 52 weeks against a placebo (a pill without any medication). The goal is to see if Ritlecitinib helps restore skin color in patients with either active spots where pigment is lost or stable conditions where there hasn't been any change.

Participant Groups

Group I: Ritlecitinib 50 mg Experimental Treatment 1 Intervention

Ritlecitinib 50 mg QD (ritilecitinib 50 mg QD arm; approximately 400 participants)

Group II: Placebo Placebo Group 1 Intervention

Placebo (placebo arm; approximately 200 participants)

Ritlecitinib is already approved in European Union, United States for the following indications:

Approved in European Union as Litfulo for:

• Severe alopecia areata

Approved in United States as Litfulo for:

• Severe alopecia areata

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 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]

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]

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]

In a preliminary study involving four patients with progressing vitiligo, treatment with oral baricitinib for 12 weeks resulted in significant re-pigmentation without major side effects, indicating its efficacy and safety.

In laboratory tests, baricitinib enhanced tyrosinase activity and melanin production in damaged melanocytes, suggesting a mechanism of action that could help restore pigmentation in vitiligo patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baricitinib is Effective in Treating Progressing Vitiligo in vivo and in vitro. Dong, J., Huang, X., Ma, LP., et al.[2022]

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 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 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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Baseline Levels of Circulating Inflammatory Biomarkers Stratify Patients with Vitiligo Who Significantly Repigment after Treatment with Ruxolitinib Cream. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Low-dose tofacitinib with 308-nm excimer therapy successfully induced repigmentation in patients with refractory vitiligo. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Topical Tofacitinib: A Janus Kinase Inhibitor for the Treatment of Vitiligo in an Adolescent Patient. [2021]

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

Review of Ruxolitinib for Treatment of Non-Segmental Vitiligo. [2023]

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

Baricitinib is Effective in Treating Progressing Vitiligo in vivo and in vitro. [2022]

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

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

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

Ritlecitinib: First Approval. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Ruxolitinib cream for treatment of vitiligo: a randomised, controlled, phase 2 trial. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. [2023]