An Open-Label Subpopulation Study to Evaluate Efficacy and Safety of Baricitinib in Participants with Alopecia Areata that Self-Identify as Black or African American in Race

Study type: Clinical Trials Posting date: 05/24/2023 Last updated: 01/29/2024 Status: Active/Fully Enrolled Phase: Phase 3 Country: United States Eligibility:

18yrs to ≤60 years for males (≤70 years of age for females); self-identify as either Black or African American in race; have severe or very severe alopecia areata

Drug: Baricitinib Administration: Oral Sponsor: Eli Lilly and Company ClinicalTrials.gov link: Click here Location: Multiple locations

Description:

This study is testing an oral drug called baricitinib (also known as the “study drug”) in people with severe alopecia areata. In this ongoing study, baricitinib therapy was demonstrated to be an efficacious therapy compared with placebo for treatment of severe alopecia areata. The purpose of the open-label subpopulation study is to ensure adequate representation of Black or African American patients, as well as further examine the effectiveness of baricitinib therapy in achieving hair regrowth in Black or African American patients with severe alopecia areata.

You may qualify to participate in this study if you:*

Are at least 18 years and ≤60 years for males (≤70 years of age for females)
Self-identify as either Black or African American in race
Have severe or very severe AA, as determined by all of the following
- Current AA episode of more than 6 months’ duration and hair loss encompassing ≥50% of the scalp
- No spontaneous improvement over the past 6 months
- Current episode of severe or very severe AA of less than 8 years

*There are additional requirements as determined by a screening process.

This subpopulation study is open-label which means that all participants will receive study drug. All participants will take the study drug once a day for 52 weeks. In total, you will be involved in the study for up to 61 weeks (1 year and 9 weeks).

If you qualify and choose to participate in this study, you will NOT be charged for:

The study drug
Study doctor visits
Laboratory work, tests, and procedures that are needed for the study

You may also be eligible for reimbursement of some costs, such as travel or transportation, depending on your location. Study staff can provide more details about costs and reimbursement for this study.

This study is taking place at locations throughout the United States.

Alabama

University of Alabama at Birmingham
Birmingham, Alabama, 35233
(205) 502-9960

California

California Dermatology & Clinical Research Institute
Encinitas, California, 92024
Contact: Ashley Johnson (ajohnson@cdcrinstitute.com)
Phone: (760) 203-3836

Dermatology Research Associates
Los Angeles, California, 90045
Contact: Jackie O’Dell (jodell@drsofen.com)
Phone: (310) 337-7171

Stanford University School of Medicine – Department of Dermatology
Redwood City, California 94603.
Contact: Niki Ai Saruwatari (nikis@stanford.edu)
Phone: (808) 485-7496
Alternate contact: Lila Perrone (perronel@stanford.edu or (415) 713-1370)
Alternate contact: Kiana Yekrang (kyekrang@stanford.edu or (650) 497-4058)

Connecticut

Yale Center for Clinical Investigation, Church Street Research Unit
New Haven, CT 06520
Phone: (475) 255-8031

Florida

ForCare Clinical Research
Tampa, Florida, 33613
Contact: Beth DeLuca (e.deluca@cenexel.com)
Phone: (813) 264-2155

University of Miami Hospital
Miami, Florida, 33125
Phone: (305) 243-8205

Kentucky

Dermatology Specialists Research (DS Research) – Kentucky
Louisville, Kentucky, 40241
Phone: (502) 459-2869

Maryland

Callender Dermatology & Cosmetic Center
Glenn Dale, Maryland, 20169
Phone: (301) 249-0970

Massachusetts

Brigham & Women’s Hospital
Boston, Massachusetts, 02115
Phone: (617) 970-4351

Minnesota

University of Minnesota Medical School
Minneapolis, MN 55455
Contact: Jamie Nugent (speck007@umn.edu) or Maria Hordinsky (hordi001@umn.edu)
Phone: (612) 625-2624

New Hampshire

ActivMed Practices & Research – LLC
Portsmouth, New Hampshire, 03801
Contact: Sarah O’Connor (sarah.oconnor@activmedresearch.com)
Phone: (603) 319-8863

Ohio

Ohio State University Dermatology East
Gahanna, Ohio, 43230
Phone: (614) 984-6814

Oregon

Northwest Dermatology Institute
Portland, Oregon, 97210
Contact: Joana Fragata
Phone (503) 223-1933

Pennsylvania

Dermatology & Skin Surgery Center
Exton, Pennsylvania, 19341
Phone: (610) 529-2589

Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania 19104
Contact: Mollie Diehl (mollie.diehl@pennmedicine.upenn.edu)
Phone: (215) 662-2737

South Carolina

Medical University of South Carolina – Charleston – Jonathan Lucas Street
Charleston, South Carolina, 29425
Contact: Alyson Winter (wintera@musc.edu)
Phone: (843) 876-3209

Texas

Center for Clinical Studies – Houston – Binz Street
Houston, Texas, 77004
Contact: Crystal Bruner (info@ccstexas.com)
Phone: (281) 343-3300

Austin Institute for Clinical Research – Pflugerville
Pflugerville, Texas 78660
Contact: Xiomara Duarte (xduarte@atxresearch.com)
Phone: (512) 279-2545

Center for Clinical Studies – Clear Lake
Webster, Texas 77598
Contact: Crystal Bruner (info@ccstexas.com)
Phone: (281) 343-3300