Alopecia Areata Clinical Trial
— BRAVE-AA1Official title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Operationally Seamless, Adaptive Phase 2/3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Severe or Very Severe Alopecia Areata
| Verified date | May 2024 |
| Source | Eli Lilly and Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study is designed to select up to two doses of baricitinib (referred to as low dose and high dose) and assess their efficacy and safety for the treatment of severe or very severe alopecia areata. An additional subpopulation of 60 participants in the US will enroll in the open-label addenda.
| Status | Active, not recruiting |
| Enrollment | 824 |
| Est. completion date | January 26, 2025 |
| Est. primary completion date | February 2, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility | Inclusion Criteria: - Are at least 18 years and =60 years for males (=70 years of age for females) at the time of informed consent. - Must self-identify as either Black or African American in race in the open label addenda. - 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, as measured by SALT Alopecia Areata Investigator Global Assessment (AA-IGA) of 3 or 4) at screening and baseline. - No spontaneous improvement over the past 6 months. - Current episode of severe or very severe AA of less than 8 years. - Male or nonpregnant, nonbreastfeeding female participants. Exclusion Criteria: - Primarily "diffuse" type of AA. - Are currently experiencing other forms of alopecia or any other concomitant conditions that would interfere with evaluations of the effect of study medication on AA. - Previously treated with an oral Janus kinase (JAK) inhibitor and had an inadequate response (for example, absence of significant terminal hair growth after at least 12 weeks of treatment). |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Hamamatsu University Hospital | Hamamatsu | Shizuoka |
| Japan | Kurume University Hospital | Kurume | Fukuoka |
| Japan | Osaka City University Hospital | Osaka | |
| Japan | Tokyo Medical University Hospital | Shinjuku-ku | Tokyo |
| Korea, Republic of | Pusan National University Hospital | Busan | Pusan-Kwangyokshi |
| Korea, Republic of | Chungnam National University Hospital | Daejeon | Taejon-Kwangyokshi |
| Korea, Republic of | Chung-Ang University Hospital | Dongjak-gu | Seoul-teukbyeolsi [Seoul] |
| Korea, Republic of | Inha University Hospital | Incheon | Incheon-gwangyeoksi [Incheon] |
| Korea, Republic of | Jeonbuk National University Hospital | Jeonju-si | Jeonrabugdo |
| Korea, Republic of | Kyungpook National University Hospital | Jung-gu | Taegu-Kwangyokshi |
| Korea, Republic of | Seoul National University Bundang Hospital | Seongnam | Kyonggi-do |
| Korea, Republic of | Konkuk University Medical Center | Seoul | Seoul-teukbyeolsi [Seoul] |
| Korea, Republic of | Kyung-Hee University Hospital at Gangdong | Seoul | Seoul-teukbyeolsi [Seoul] |
| Korea, Republic of | Seoul National University Hospital | Seoul | Seoul-teukbyeolsi [Seoul] |
| Korea, Republic of | The Catholic University of Korea, Eunpyeong St. Mary's Hospital | Seoul | Seoul-teukbyeolsi [Seoul] |
| Mexico | Derma Norte del Bajío | Aguascalientes | |
| Mexico | Instituto de Investigaciones Aplicadas a la Neurociencia A.C | Durango | |
| Mexico | Centro de Atención en Enfermedades Inflamatorias CATEI | Guadalajara | Jalisco |
| Mexico | Clinica de Investigacion en Reumatologia y Obesidad S. C. | Guadalajara | Jalisco |
| Mexico | B&B Investigaciones Medicas, SC | Mazatlan | Sinaloa |
| Mexico | RM Pharma Specialists | Mexico City | Distrito Federal |
| Mexico | Centro Regiomontano de Investigacion | Monterrey | Nuevo Leon |
| Mexico | Hospital Universitario Dr. Jose Eleuterio Gonzalez | Monterrey | Nuevo León |
| Puerto Rico | Ponce Medical School Foundation Inc. | Ponce | |
| Puerto Rico | GCM Medical Group, PSC- Hato Rey Site | San Juan | |
| United States | Bellaire Dermatology Associates | Bellaire | Texas |
| United States | ActivMed Practices and Research | Beverly | Massachusetts |
| United States | University of Alabama at Birmingham | Birmingham | Alabama |
| United States | Brigham and Women's Hospital | Boston | Massachusetts |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | Montefiore Medical Center | Bronx | New York |
| United States | Medical University of South Carolina | Charleston | South Carolina |
| United States | Northwestern University | Chicago | Illinois |
| United States | Clarkston Skin Research | Clarkston | Michigan |
| United States | Cleveland Clinic | Cleveland | Ohio |
| United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
| United States | Ohio State University | Columbus | Ohio |
| United States | Modern Research Associates | Dallas | Texas |
| United States | California Dermatology & Clinical Research Institute | Encinitas | California |
| United States | The Pennsylvania Centre for Dermatology, LLC | Exton | Pennsylvania |
| United States | Johnson Dermatology | Fort Smith | Arkansas |
| United States | Callender Center For Clinical Research | Glenn Dale | Maryland |
| United States | Penn State Univ. Milton S. Hershey Medical Center | Hershey | Pennsylvania |
| United States | Center for Clinical Studies | Houston | Texas |
| United States | Tilda Research | Irvine | California |
| United States | University of California, Irvine | Irvine | California |
| United States | Solutions Through Advanced Research | Jacksonville | Florida |
| United States | Dermatology Research Associates | Los Angeles | California |
| United States | DS Research | Louisville | Kentucky |
| United States | Skin Care Physicians of Georgia | Macon | Georgia |
| United States | University of Miami Miller School of Medicine | Miami | Florida |
| United States | M Health Fairview University of Minnesota Medical Center - East Bank | Minneapolis | Minnesota |
| United States | Coastal Clinical Research, Inc | Mobile | Alabama |
| United States | University of Utah | Murray | Utah |
| United States | Yale University School of Medicine | New Haven | Connecticut |
| United States | Medaphase Inc | Newnan | Georgia |
| United States | Park Avenue Dermatology | Orange Park | Florida |
| United States | Austin Institute for Clinical Research | Pflugerville | Texas |
| United States | Penn Medicine: University of Pennsylvania Health System | Philadelphia | Pennsylvania |
| United States | UPMC Clinical Trials | Pittsburgh | Pennsylvania |
| United States | Dermatology Associates of Plymouth Meeting | Plymouth Meeting | Pennsylvania |
| United States | Northwest Dermatology Institute | Portland | Oregon |
| United States | Oregon Health and Science University | Portland | Oregon |
| United States | Oregon Medical Research Center | Portland | Oregon |
| United States | ActivMed Practices & Research, Inc. | Portsmouth | New Hampshire |
| United States | Stanford Medicine Outpatient Center | Redwood City | California |
| United States | University of Rochester School of Medicine | Rochester | New York |
| United States | University of California Davis Health | Sacramento | California |
| United States | Dermatology Clinical Research Center of San Antonio | San Antonio | Texas |
| United States | Texas Dermatology and Laser Specialists | San Antonio | Texas |
| United States | University Clinical Trials | San Diego | California |
| United States | Mosaic Dermatology | Santa Monica | California |
| United States | Dermatology Associates of Seattle | Seattle | Washington |
| United States | ForCare Clinical Research | Tampa | Florida |
| United States | Center for Clinical Studies, LTD.LLP | Webster | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company | Incyte Corporation |
United States, Japan, Korea, Republic of, Mexico, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants Achieving Severity of Alopecia Tool (SALT) = 20 | Percentage of Participants Achieving SALT = 20 | Week 36 | |
| Secondary | Percentage of Participants Achieving 50% Improvement of SALT (SALT50) | Percentage of participants achieving SALT50 | Week 12 | |
| Secondary | Percent Change from Baseline in SALT Score | Percent change from baseline in SALT score | Baseline, Week 36 | |
| Secondary | Time for Participants to Achieve SALT = 20 | Time for Participants to Achieve SALT = 20 | Baseline through Week 36 | |
| Secondary | Percentage of Participants Achieving Clinician Reported Outcome (ClinRO) Measure for EyeBrow (EB) Hair Loss 0 or 1 with =2-point improvement from Baseline (Among Participants with ClinRO Measure for EB Hair Loss =2 at Baseline) | Percentage of participants achieving ClinRO measure for EB hair loss 0 or 1 with =2-point improvement from Baseline (among participants with ClinRO measure for EB hair loss =2 at baseline) | Week 36 | |
| Secondary | Percentage of Participants Achieving ClinRO Measure for Eye Lash (EL) Hair Loss 0 or 1 with =2-point improvement from Baseline (Among Participants with ClinRO Measure for EL Hair Loss =2 at Baseline) | Percentage of participants achieving ClinRO measure for EL hair loss 0 or 1 with =2-point improvement from Baseline (among participants with ClinRO measure for EL hair loss =2 at baseline) | Week 36 | |
| Secondary | Percentage of Participants Achieving PRO Measure for EB 0 or 1 with =2-point improvement from Baseline (Among Participants with Patient Reported Outcome (PRO) Measure for EB =2 at Baseline) | Percentage of participants achieving PRO measure for EB 0 or 1 with =2-point improvement from Baseline (among participants with PRO measure for EB =2 at baseline) | Week 36 | |
| Secondary | Percentage of Participants Achieving PRO Measure for EL 0 or 1 with =2-point improvement from Baseline (Among Participants with PRO Measure EL =2 at Baseline) | Percentage of participants achieving PRO measure for EL 0 or 1 with =2-point improvement from Baseline (among participants with PRO measure EL =2 at baseline) | Week 36 | |
| Secondary | Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score | Mean Change From Baseline in HADS Anxiety Score | Week 36 | |
| Secondary | Mean Change From Baseline in HADS Depression Score | Mean Change From Baseline in HADS Depression Score | Week 36 |
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