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Trial record 2 of 5 for:    Recruiting Studies | Interventional Studies | Alopecia Areata | United States | Adult | Phase 2 | Industry

Safety and Efficacy of Oral Etrasimod in Adult Participants With Moderate-to-Severe Alopecia Areata

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04556734
Recruitment Status : Recruiting
First Posted : September 21, 2020
Last Update Posted : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
Arena Pharmaceuticals

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of etrasimod monotherapy (2 milligrams [mg]) in participants with moderate-to-severe alopecia areata.

Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: Etrasimod Drug: Placebo Phase 2

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Study Type : Interventional
Estimated Enrollment : 36 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 : December 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Etrasimod 2 mg Drug: Etrasimod
Etrasimod 2 mg tablet by mouth, once daily
Other Name: APD334

Placebo Comparator: Placebo Drug: Placebo
Etrasimod 2 mg matching placebo tablet by mouth, once daily




Primary Outcome Measures :
  1. Percent Change From Baseline in Severity of Alopecia Tool (SALT) [ Time Frame: Baseline to Week 24 ]

Secondary Outcome Measures :
  1. Change From Baseline in SALT [ Time Frame: Baseline to Week 24 ]
  2. Proportion of Participants Achieving a 30% Improvement From Baseline in SALT (SALT30) [ Time Frame: Baseline to Week 24 ]
  3. Proportion of Participants Achieving a 50% Improvement From Baseline in SALT (SALT50) [ Time Frame: Baseline to Week 24 ]
  4. Proportion of Participants Achieving a 75% Improvement From Baseline in SALT (SALT75) [ Time Frame: Baseline to Week 24 ]
  5. 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 (AA) as assessed by a SALT score of ≥50
  • Current episode of hair loss for ≥6 months but <8 years
  • Stable disease condition (ie, no significant growth or loss 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 an oral Janus kinase (JAK) inhibitor, 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
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Contact: Arena CT.gov Administrator +1 855-218-9153 ct.gov@arenapharm.com

Locations
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United States, Oregon
NW Dermatology Institute Recruiting
Portland, Oregon, United States, 97210
United States, Tennessee
International Clinical Research - Tennessee LLC Recruiting
Murfreesboro, Tennessee, United States, 37130
United States, Washington
Dermatology Specialists of Spokane Recruiting
Spokane, Washington, United States, 99202
Canada, Quebec
Innovaderm Research Inc. Recruiting
Montreal, Quebec, Canada, H2X 2V1
Sponsors and Collaborators
Arena Pharmaceuticals
Investigators
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Study Director: Arena CT.gov Administrator Arena Pharmaceuticals
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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: September 21, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arena Pharmaceuticals:
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