Safety and Efficacy of Oral Etrasimod in Adult Participants With Moderate-to-Severe Alopecia Areata
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| ClinicalTrials.gov Identifier: NCT04556734 |
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Recruitment Status :
Recruiting
First Posted : September 21, 2020
Last Update Posted : March 16, 2022
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Sponsor:
Arena Pharmaceuticals
Information provided by (Responsible Party):
Arena Pharmaceuticals
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Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of etrasimod monotherapy (2 milligrams [mg] and 3 mg) in participants with moderate-to-severe alopecia areata (AA).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alopecia Areata | Drug: Etrasimod Drug: Placebo | Phase 2 |
| Study Type : | Interventional |
| Estimated Enrollment : | 78 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Double-Blind, Placebo-Controlled |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 24-Week Study, With a 28-Week Open-Label Extension, to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Alopecia Areata |
| Actual Study Start Date : | August 31, 2020 |
| Estimated Primary Completion Date : | May 2023 |
| Estimated Study Completion Date : | October 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Alopecia areata
| Arm | Intervention/treatment |
|---|---|
| Experimental: Etrasimod 2 mg |
Drug: Etrasimod
Etrasimod 2 mg tablet by mouth, once daily
Other Name: APD334 |
| Experimental: Etrasimod 3 mg |
Drug: Etrasimod
Etrasimod 3 mg (1 mg and 2 mg tablets) by mouth, once daily
Other Name: APD334 |
| Placebo Comparator: Placebo |
Drug: Placebo
Etrasimod matching placebo tablet by mouth, once daily |
Primary Outcome Measures :
- Percent Change From Baseline in Severity of Alopecia Tool (SALT) [ Time Frame: Baseline to Week 24 ]
Secondary Outcome Measures :
- Change From Baseline in SALT [ Time Frame: Baseline to Week 24 ]
- Proportion of Participants Achieving ≥30% Improvement From Baseline in SALT [ Time Frame: Baseline to Week 24 ]
- Proportion of Participants Achieving ≥50% Improvement From Baseline in SALT [ Time Frame: Baseline to Week 24 ]
- Proportion of Participants Achieving ≥75% Improvement From Baseline in SALT [ Time Frame: Baseline to Week 24 ]
- Number and Severity of Adverse Events (Double-Blind Treatment Period and Open-Label Extension Period) [ Time Frame: Up to approximately 56 weeks (24-weeks of Double-Blind Treatment Period, 28-weeks of Open-Label Extension Period, and 4-weeks of Safety Follow-Up Period) ]Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Men or women between ≥18 and ≤70 years of age at the time of informed consent
- Moderate-to-severe alopecia areata as assessed by a SALT score of ≥25 and <95 at Screening and Day 1/Baseline.
- Current episode of hair loss for ≥6 months but <5 years
- Stable disease condition (no significant growth of hair) in the last 6 months as assessed by the Investigator
- Willing to keep the same hair style and color (eg, hair products, process, and timing for hair appointments) for the duration of the study
Key Exclusion Criteria:
- History of male or female pattern hair loss >Hamilton stage III or >Ludwig stage II
- Other types of alopecia (eg, cicatricial/scarring alopecia [including central centrifugal cicatricial alopecia], traction alopecia, or telogen effluvium) or other diseases that could cause hair loss
- Active scalp inflammation, scalp infection, scalp psoriasis, or any other scalp condition that may interfere with the SALT assessment
- Previous use of Janus kinase (JAK) inhibitor (oral or topical), including participation in clinical studies of JAK inhibitors
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04556734
Contacts
| Contact: Arena CT.gov Administrator | +1 855-218-9153 | ct.gov@arenapharm.com |
Locations
Show 29 study locations
Sponsors and Collaborators
Arena Pharmaceuticals
Investigators
| Study Director: | Arena CT.gov Administrator | Arena Pharmaceuticals |
| Responsible Party: | Arena Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT04556734 |
| Other Study ID Numbers: |
APD334-205 |
| First Posted: | September 21, 2020 Key Record Dates |
| Last Update Posted: | March 16, 2022 |
| Last Verified: | March 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Arena Pharmaceuticals:
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T-cell-mediated autoimmune skin disorder Alopecia areata Alopecia |
APD334 Etrasimod Hair loss |
Additional relevant MeSH terms:
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Alopecia Alopecia Areata Hypotrichosis |
Hair Diseases Skin Diseases Pathological Conditions, Anatomical |