CTP-543 for Alopecia Areata

Recruiting at 94 trial locations

Overseen By Colleen E. Hamilton, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Concert Pharmaceuticals

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

1000 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing CTP-543, a medication that may help people regrow hair by stopping the immune system from attacking hair follicles. It focuses on adults with chronic, moderate to severe alopecia areata. CTP-543 has shown promise in treating this condition.

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.

How is the drug CTP-543 different from other treatments for alopecia areata?

CTP-543 is unique because it is a Janus kinase (JAK) inhibitor, which targets specific pathways involved in the autoimmune response that causes hair loss in alopecia areata. This mechanism of action is different from traditional treatments like steroids or minoxidil, which do not specifically target the immune system. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: CTP-543 Experimental Treatment 1 Intervention

Patients who previously completed a qualifying CTP-543 clinical trial

Who Is Running the Clinical Trial?

Concert Pharmaceuticals

Lead Sponsor

Trials

35

Recruited

4,400+

References

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

Altered T cell subpopulations and serum anti-TYRP2 and tyrosinase antibodies in the acute and chronic phase of alopecia areata in the C3H/HeJ mouse model. [2022]

2. Italy pubmed.ncbi.nlm.nih.gov

Single nucleotide polymorphisms in the promoter regions of Foxp3 and ICOSLG genes are associated with Alopecia areata. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Topical SCD-153, a 4-methyl itaconate prodrug, for the treatment of alopecia areata. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

ULBP3: a marker for alopecia areata incognita. [2017]

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

Treatment of alopecia areata: "What is new on the horizon?". [2011]