Deucravacitinib for Alopecia Areata

No longer recruiting at 48 trial locations

Overseen By BMS Study Connect Contact Center www.BMSStudyConnect.com

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Bristol-Myers Squibb

Disqualifiers: Diffuse alopecia, Traction alopecia, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

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 new medication, deucravacitinib, to determine its effectiveness for alopecia areata, a condition causing hair loss. Researchers aim to assess the treatment's efficacy and safety compared to a placebo (a pill with no active ingredient). Participants will receive one of two doses of deucravacitinib or start with a placebo and then switch to the medication. Suitable candidates have experienced alopecia areata for at least six months, with hair loss affecting over half of their scalp. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

Is there any evidence suggesting that deucravacitinib is likely to be safe for humans?

Research has shown that deucravacitinib is being tested for safety in treating alopecia areata, but specific safety information for this condition remains limited. Deucravacitinib, also known as Sotyktu™, is already approved for moderate to severe plaque psoriasis, providing some insight into its safety in humans. Long-term studies in psoriasis treatment have demonstrated that the drug remains effective for up to two years with ongoing use, though detailed safety results for alopecia areata are not yet available.

This treatment is currently in Phase 2 trials, where researchers continue to assess how well people tolerate the drug and identify potential side effects. Generally, reaching this stage indicates that earlier studies have shown enough promise for the treatment to be considered reasonably safe for further testing. Prospective trial participants should know that safety is a primary focus at this stage, and the study team will closely monitor any side effects. ^{1 2 3 4 5}

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

Deucravacitinib is unique because it targets alopecia areata differently from existing treatments like corticosteroids or immunosuppressants. Most treatments for alopecia areata work by broadly suppressing the immune system. However, deucravacitinib specifically inhibits the TYK2 enzyme, which plays a crucial role in the immune pathways involved in the condition. This targeted approach has the potential to offer more effective results with fewer side effects, making researchers hopeful for its impact on patients' lives.

What evidence suggests that deucravacitinib might be an effective treatment for alopecia areata?

Research shows that deucravacitinib may help treat alopecia areata, a condition characterized by patchy hair loss. In this trial, participants will initially receive either deucravacitinib at different doses or a placebo, followed by deucravacitinib. In one case, a patient with alopecia universalis, a severe form of the condition, experienced rapid hair regrowth after starting deucravacitinib. This suggests the medication might aid in hair regrowth. Additionally, long-term studies on deucravacitinib for other conditions, such as plaque psoriasis, have demonstrated its effectiveness for up to two years. These findings indicate that deucravacitinib could benefit people with alopecia areata, but further research is necessary to confirm this. ^{1 2 4 6 7}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for adults with Alopecia Areata who've had the condition for at least 6 months, with current hair loss affecting over half their scalp and stable for the past 6 months. They should have a SALT score of at least 50, indicating significant hair loss. Those with other types of hair loss or skin conditions that could affect scalp assessment can't participate.

Inclusion Criteria

You have a high score for scalp hair loss, and if you have complete scalp hair loss, you may still be included.

My current scalp hair loss has lasted at least 6 months but not more than 8 years, and hasn't improved significantly in the last 6 months.

You have a SALT score of at least 50, which measures the amount of scalp hair loss. If you have complete scalp hair loss (SALT score of 100), with or without body hair loss, you can still participate.

Exclusion Criteria

I do not have skin conditions on my scalp that could affect hair loss evaluation.

You have a lot of tattoos on your scalp that could make it hard for the doctor to measure your skin condition accurately.

I have a type of hair loss such as diffuse AA or traction alopecia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Placebo-Controlled Treatment

Participants receive either deucravacitinib or placebo to evaluate efficacy and safety

24 weeks

Regular visits for monitoring and assessments

Active Treatment

Participants receive active treatment with deucravacitinib to further assess safety and efficacy

28 weeks

Regular visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Deucravacitinib
• Placebo

Trial Overview The study is testing Deucravacitinib's effectiveness compared to a placebo in improving symptoms by Week 24. Participants will be randomly assigned to receive either Deucravacitinib or a placebo, allowing researchers to measure the drug's true impact on Alopecia Areata.

How Is the Trial Designed?

Group I: Deucravacitinib Dose 2 Experimental Treatment 2 Interventions

Group II: Deucravacitinib Dose 1 Experimental Treatment 2 Interventions

Group III: Placebo, followed by Deucravacitinib Dose 1 or Dose 2. Placebo Group 2 Interventions

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

Approved in United States as Sotyktu for:

• Moderate to severe plaque psoriasis

Approved in European Union as Sotyktu for:

• Moderate to severe plaque psoriasis

Approved in Canada as Sotyktu for:

• Moderate to severe plaque psoriasis

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Published Research Related to This Trial

In a long-term study involving two patients with alopecia areata, oral ruxolitinib led to sustained, near-complete hair regrowth over a year without any significant side effects.

The results suggest that ruxolitinib is a safe and effective treatment option for individuals with alopecia who do not respond to other therapies, warranting its consideration in community dermatology settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two cases of alopecia areata treated with ruxolitinib: a discussion of ideal dosing and laboratory monitoring. Vandiver, A., Girardi, N., Alhariri, J., et al.[2021]

Baricitinib, a JAK inhibitor, is the first approved treatment for severe alopecia areata, showing significant hair regrowth in scalp, eyebrows, and eyelashes over 36 weeks in two phase 3 clinical trials.

The drug was generally well tolerated, with common side effects including infections and headaches, indicating it is a promising option for patients suffering from this challenging condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baricitinib: A Review in Severe Alopecia Areata. Fung, S., Shirley, M.[2023]

In the phase 2a ALLEGRO trial involving 142 adults with alopecia areata, both ritlecitinib and brepocitinib significantly improved patient-reported outcomes (AASIS scores) and clinician-assessed hair loss (SALT scores) after 24 weeks compared to placebo.

The study found medium-to-large correlations between patient-reported outcomes and clinician assessments, indicating that both measures are important for evaluating treatment effectiveness in alopecia areata.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing the relationships between patient-reported outcomes and clinician assessments of alopecia areata in a phase 2a randomized trial of ritlecitinib and brepocitinib. Winnette, R., Banerjee, A., Sikirica, V., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05556265

NCT05556265 | A Study to Evaluate Efficacy and Safety of ... The purpose of this study is to evaluate the efficacy of deucravacitinib versus placebo at Week 24 and safety and tolerability of deucravacitinib versus placebo ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/65/NCT05556265/Prot_SAP_000.pdf

A Multi-center, Randomized, Double-blind, Placebo- ... Deucravacitinib will be compared to placebo to evaluate the efficacy of deucravacitinib versus placebo for the treatment of alopecia areata.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10687936/

Rapid hair regrowth in an alopecia universalis patient with ... We report the first case of successful rapid hair regrowth after starting deucravacitinib, which should prompt further inquiry into the use of TYK2 inhibitors.

4. news.bms.com news.bms.com/news/details/2022/Bristol-Myers-Squibb-Announces-New-Sotyktu-deucravacitinib-Long-Term-Data-Showing-Clinical-Efficacy-Maintained-for-Up-to-Two-Years-with-Continuous-Treatment-in-Moderate-to-Severe-Plaque-Psoriasis/default.aspx

Bristol Myers Squibb Announces New Sotyktu™ ... “These new long-term results showing durable efficacy through up to two years of continuous treatment further support the use of once-daily ...

5. mdpi.com mdpi.com/1422-0067/26/19/9447

Review of Promising Off-Label Use of Deucravacitinib The efficacy and safety of JAK inhibitors for alopecia areata: A systematic review and meta-analysis of prospective studies. Front. Pharmacol. 2022, 13 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12454744/

Evaluating Current and Emergent JAK Inhibitors for ... However, data for safety outcomes in patients with AA are very limited. A recent retrospective chart review consisting of 36 children and ...

7. naaf.org naaf.org/studies/a-study-to-evaluate-efficacy-and-safety-of-deucravacitinib-in-participants-with-alopecia-areata/

A Study to Evaluate Efficacy and Safety of Deucravacitinib ... This study is testing an oral investigational drug called deucravacitinib (also known as the “study drug”) in people with alopecia areata.