What is the mechanism of action of this treatment?

Janus kinase (JAK) inhibitors, such as tofacitinib and the investigational drug CTP-543, work by interfering with the JAK-STAT signaling pathway, which is involved in the immune response that attacks hair follicles in Alopecia Areata. By inhibiting this pathway, JAK inhibitors can reduce inflammation and prevent the immune system from targeting hair follicles, promoting hair regrowth. Other common treatments include topical corticosteroids, which reduce local inflammation, and immunotherapy agents like diphenylcyclopropenone (DPCP), which modulate the immune response. Understanding these mechanisms is crucial for patients, as it helps them make informed decisions about their treatment options and manage expectations regarding efficacy and potential side effects.

What side effects are associated with this type of intervention?

Janus kinase (JAK) inhibitors, such as tofacitinib and baricitinib, used for treating alopecia areata can cause side effects including increased risk of infections, elevated liver enzymes, and changes in blood counts. Other common treatments for alopecia areata include corticosteroids, which can lead to skin thinning and systemic effects if used long-term; minoxidil, which may cause scalp irritation and unwanted facial hair growth; and immunosuppressants like methotrexate and cyclosporine, which require close monitoring due to potential liver toxicity, bone marrow suppression, and increased risk of infections.

What prior FDA approvals exist?

As of now, the FDA has approved baricitinib, a Janus kinase (JAK) inhibitor, for the treatment of alopecia areata. Baricitinib works by inhibiting the activity of specific enzymes involved in the inflammatory process that contributes to hair loss in alopecia areata. Other JAK inhibitors, such as tofacitinib and ruxolitinib, have shown promise in clinical trials but are not yet FDA-approved specifically for alopecia areata. These treatments represent a significant advancement in managing this condition, offering new hope for patients with moderate to severe forms of alopecia areata.

What other types of research exist?

Promising alternatives to CTP-543 for Alopecia Areata include: <ol> <li>Tofacitinib 2% ointment: Shown to improve hair regrowth in both adults and children, particularly those refractory to corticosteroids.</li> <li></li> </ol> Dupilumab: A phase 2 trial indicated potential benefits, with 33% of patients achieving at least 30% improvement in the SALT score after 48 weeks. Further studies are needed to confirm efficacy.

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JAK Inhibitor

CTP-543 for Alopecia Areata

Phase 2 & 3

Waitlist Available

Research Sponsored by Concert Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis

Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of CTP-543 aren't listed here, common ones may include reactions at the pill intake site, gastrointestinal symptoms like nausea or diarrhea, headaches, fatigue or allergic reactions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2022 Phase 3 trial • 706 Patients • NCT04518995

12%

Headache

Acne

Blood creatine phosphokinase (increased)

COVID-19

Nasopharyngitis

Upper respiratory tract infection

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

CTP-543 8 mg BID

CTP-543 12 mg BID

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CTP-543Experimental Treatment1 Intervention

Patients who previously completed a qualifying CTP-543 clinical trial

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CTP-543

2021

Completed Phase 3

~2520

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Janus kinase (JAK) inhibitors, such as tofacitinib and the investigational drug CTP-543, work by interfering with the JAK-STAT signaling pathway, which is involved in the immune response that attacks hair follicles in Alopecia Areata. By inhibiting this pathway, JAK inhibitors can reduce inflammation and prevent the immune system from targeting hair follicles, promoting hair regrowth. Other common treatments include topical corticosteroids, which reduce local inflammation, and immunotherapy agents like diphenylcyclopropenone (DPCP), which modulate the immune response. Understanding these mechanisms is crucial for patients, as it helps them make informed decisions about their treatment options and manage expectations regarding efficacy and potential side effects.

Case Report: Successful Treatment of Alopecia Universalis With Tofacitinib and Increased Cytokine Levels: Normal Therapeutic Reaction or Danger Signal?