CTP-543 for Alopecia Areata

Not currently recruiting at 94 trial locations

Overseen By Colleen E. Hamilton, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Sun Pharmaceutical Industries, Inc.

Disqualifiers: Scalp inflammation, Psoriasis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called CTP-543, a potential new drug, to determine its safety and effectiveness in promoting hair regrowth for individuals with long-term, moderate to severe alopecia areata, a condition causing hair loss. The study aims to assess the long-term effectiveness of CTP-543. Suitable participants have already completed treatment in a previous CTP-543 study and do not have scalp conditions, such as psoriasis, that require treatment. As a Phase 2 trial, this research measures CTP-543's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that CTP-543 is likely to be safe for humans?

Studies have shown that CTP-543 is generally well tolerated in people with moderate to severe alopecia areata, a condition that causes hair loss. Research indicates that both doses of CTP-543 have a promising safety record, as most participants did not experience serious side effects. Although some individuals might have mild reactions, the treatment is considered safe enough for continued testing in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

CTP-543 is unique because it targets alopecia areata in a different way than most existing treatments. While traditional options often focus on suppressing the immune system broadly, CTP-543 is a Janus kinase (JAK) inhibitor, which specifically interferes with the JAK pathways involved in the autoimmune attack on hair follicles. This targeted approach may offer more effective results with potentially fewer side effects. Researchers are excited about CTP-543 because it holds the promise of regrowing hair by directly addressing the underlying cause of the condition.

What evidence suggests that CTP-543 might be an effective treatment for alopecia areata?

Research has shown that CTP-543 effectively treats alopecia areata, a condition causing hair loss. Studies have found that many patients with moderate to severe hair loss experienced noticeable hair regrowth after using CTP-543. Specifically, after 24 weeks of treatment, many patients had less than 20% hair loss on their scalp. This result indicates that CTP-543 can significantly improve hair regrowth and increase patient satisfaction. Overall, the evidence supports optimism about the treatment's potential to help those with significant hair loss due to alopecia areata. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with moderate to severe alopecia areata who have already completed 24 weeks of treatment in a prior CTP-543 study. Participants should not have donated blood recently, must not have active scalp conditions needing topical treatments, and females should not be nursing, pregnant or planning pregnancy during the study and for a month after.

Inclusion Criteria

Have completed 24 weeks of treatment in a previous qualifying CTP-543 clinical trial

Exclusion Criteria

I have scalp conditions like psoriasis needing topical treatment, significant scalp trauma, or untreated actinic keratosis.

I agree to give blood for the study and 30 days after my last dose.

I am not pregnant, nursing, or planning to become pregnant during the study and for 30 days after.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label extension

Participants continue to receive CTP-543 to evaluate long-term safety and efficacy

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CTP-543

Trial Overview The trial is testing the long-term safety and effectiveness of a drug called CTP-543 for treating hair loss caused by alopecia areata. It's an extension study, meaning it continues from previous research on the same medication.

How Is the Trial Designed?

Group I: CTP-543 Experimental Treatment 1 Intervention

Patients who previously completed a qualifying CTP-543 clinical trial

Who Is Running the Clinical Trial?

Sun Pharmaceutical Industries, Inc.

Lead Sponsor

Concert Pharmaceuticals

Lead Sponsor

Trials

35

Recruited

4,400+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03137381

Study to Evaluate the Safety and Efficacy of CTP-543 in ... This study will evaluate the safety and efficacy of CTP-543 on hair loss in adults with chronic, moderate to severe alopecia areata. This is a double-blind, ...

2. jaad.org jaad.org/article/S0190-9622%2822%2900537-0/fulltext

Phase 2 randomized, dose-ranging trial of CTP-543, a ... The results of treatment with CTP-543 suggest that this is an effective treatment for patients with ≥50% scalp hair loss. Alopecia areata (AA), ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12539349/

PMC - PubMed Central In conclusion, deuruxolitinib shows promising efficacy in treating moderate to severe AA, leading to significant improvements in hair regrowth and patient- ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0190962224025507

Original article Efficacy and safety of deuruxolitinib, an oral ... Significant proportions of adult patients with alopecia areata and ≥50% scalp hair loss achieved ≤20% scalp hair loss during 24 weeks of treatment with ...

5. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2024/217900Orig1s000MultidisciplineR.pdf

217900Orig1s000 MULTI-DISCIPLINE REVIEW Summary ... To establish the effectiveness of deuruxolitinib (CTP-543) for the treatment of AA, the Applicant submitted data from two adequate and well-.

6. jaad.org jaad.org/article/S0190-9622(23)01699-7/fulltext

42736 Safety Assessments in the Multinational Phase 3 ... Both doses of CTP-543 were generally well tolerated. The overall safety profile of CTP-543 in patients with moderate to severe alopecia areata is encouraging.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04518995

NCT04518995 | Study to Evaluate the Efficacy and Safety ... This study evaluates the safety and effectiveness of an investigational study drug (called CTP-543) in adults (18 years and older) who have 50% or greater scalp ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0190962222005370

Phase 2 randomized, dose-ranging trial of CTP-543, a ... The primary objective of this phase 2 trial was to assess the safety and efficacy of a range of doses of CTP-543 in adult patients with moderate-to-severe AA.