--- title: Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA2) nct_id: NCT04797650 overall_status: COMPLETED phase: PHASE3 sponsor: Concert Pharmaceuticals study_type: INTERVENTIONAL primary_condition: Alopecia Areata countries: United States, Canada, France, Germany, Hungary, Poland, Spain canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04797650.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04797650" ct_last_update_post_date: 2023-07-03 last_seen_at: "2026-05-12T06:04:14.185Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA2) **Official Title:** A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata **NCT ID:** [NCT04797650](https://clinicaltrials.gov/study/NCT04797650) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 517 - **Lead Sponsor:** Concert Pharmaceuticals - **Conditions:** Alopecia Areata - **Start Date:** 2021-06-10 - **Completion Date:** 2022-06-29 - **CT.gov Last Update:** 2023-07-03 ## Brief Summary This study evaluates the safety and effectiveness of an investigational study drug (called CTP-543) in adults (18 years and older) who have 50% or greater scalp hair loss. ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 65 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * Clinical presentation compatible with alopecia areata with a current episode lasting at least 6 months and not exceeding 10 years at the time of Screening. Total disease duration greater than 10 years is permitted. * At least 50% scalp hair loss, as defined by a Severity of Alopecia Tool (SALT) score ≥50, at Screening and Baseline. * Willing to comply with the study visits and requirements of the study protocol. Exclusion Criteria: * Treatment with other medications or agents within 1 month of Baseline or during the study that may affect hair regrowth or immune response. * Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or other scalp condition that may interfere with the SALT assessment, or untreated actinic keratosis anywhere on the body at Screening and/or Baseline. * Treatment with systemic immunosuppressive medications within 3 months of Screening or during the study, or biologics within 6 months of Screening or during the study. * Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug. * Clinically significant medical condition, psychiatric disease, or social condition, as determined by the Investigator, that may unfavorably alter the risk-benefit of study participation, adversely affect study compliance, or confound interpretation of study results. ``` ## Arms - **Placebo** (PLACEBO_COMPARATOR) — Participants received CTP-543 matched placebo tablets, orally, twice daily (BID) for up to 24 weeks. - **CTP-543 8 mg BID** (EXPERIMENTAL) — Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks. - **CTP-543 12 mg BID** (EXPERIMENTAL) — Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks. ## Interventions - **CTP-543 matching placebo** (DRUG) — Administered as tablets. - **CTP-543** (DRUG) — Administered as tablets. ## Primary Outcomes - **Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Score ≤20 at Week 24** _(time frame: Week 24)_ — SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss). ## Secondary Outcomes - **Percentage of Responders on the Hair Satisfaction Participants Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24** _(time frame: Weeks 12, 16, 20, and 24)_ - **Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20** _(time frame: Weeks 4, 8, 12, 16, and 20)_ - **Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24** _(time frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24)_ - **Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20, and 24** _(time frame: Weeks 12, 16, 20, and 24)_ - **Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24** _(time frame: Weeks 12, 16, 20, and 24)_ - **Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24** _(time frame: Baseline, Weeks 12, 16, 20, and 24)_ - **Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24** _(time frame: Baseline, Weeks 12, 16, 20, and 24)_ - **Percentage of Participants Achieving at Least a 75% and 90% Relative Reduction in SALT Score From Baseline at Weeks 12 and 24** _(time frame: Baseline, Weeks 12, and 24)_ - **Change in the Brigham Eyebrow Tool for Alopecia (BETA) Scores From Baseline at Weeks 12 and 24** _(time frame: Baseline, Weeks 12, and 24)_ - **Change in the Brigham Eyelash Tool for Alopecia (BELA) Scores From Baseline at Weeks 12 and 24** _(time frame: Baseline, Weeks 12, and 24)_ - **Change in the SPRO Scale From Baseline at Weeks 12, 16, 20, and 24** _(time frame: Baseline, Weeks 12, 16, 20 and 24)_ - **Percentage of Participants Achieving a ≥2-point Change From Baseline in the SPRO Scale at Weeks 12, 16, 20, and 24** _(time frame: Weeks 12, 16, 20, and 24)_ - **Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24** _(time frame: Baseline, Weeks 12, 16, 20, and 24)_ - **Change in the Anxiety and Depression Scale Scores of the Hospital Anxiety and Depression Scale (HADS) From Baseline at Week 24** _(time frame: Baseline and Week 24)_ - **Percentage of Participants Achieving an Absolute SALT Score of ≤10 at Week 24** _(time frame: Week 24)_ ## Locations (63) - Alliance Dermatology & Mohs Center, Phoenix, Arizona, United States - Johnson Dermatology, Fort Smith, Arkansas, United States - Dermatology Research Associates, Los Angeles, California, United States - University of Miami Hospital, Miami, Florida, United States - Floridian Research Institute LLC, Miami, Florida, United States - MetroBoston Clinical Partners, LLC, Brighton, Massachusetts, United States - Clinical Research Institute of Michigan, LLC, Chesterfield, Michigan, United States - Hamzavi Dermatology, Fort Gratiot, Michigan, United States - Galen Research, Chesterfield, Missouri, United States - Vivida Dermatology, Las Vegas, Nevada, United States - The Dermatology Group P.C., Verona, New Jersey, United States - Icahn School of Medicine at Mount Sinai, New York, New York, United States - Columbia University Medical Center - Department of Dermatology, New York, New York, United States - University of Rochester, Rochester, New York, United States - Dermatologists of Southwest Ohio, Mason, Ohio, United States - Oregon Medical Research, Portland, Oregon, United States - Velocity Clinical Research - Providence, Warwick, Rhode Island, United States - The Skin Wellness Center, Knoxville, Tennessee, United States - North Texas Center for Clinical Research, Frisco, Texas, United States - Elixir Research Group, Houston, Texas, United States - Progressive Clinical Research, San Antonio, Texas, United States - Velocity Clinical Research/Gateway, Salt Lake City, Utah, United States - Velocity Clinical Research/Swinyer-Woseth Dermatology, Salt Lake City, Utah, United States - Jordan Valley Dermatology Center, South Jordan, Utah, United States - The Rector and Visitors of the University of Virginia, Charlottesville, Virginia, United States - Care Clinic Ltd., Red Deer, Alberta, Canada - Medical Arts Health Research Group, Kelowna, British Columbia, Canada - Kingsway Clinical Research, Etobicoke, Ontario, Canada - North Bay Dermatology Centre, North Bay, Ontario, Canada - The Centre for Dermatology, Richmond Hill, Ontario, Canada - Centre de Recherche Saint-Louis, Québec, Canada - Centre de Recherche Dermatologique du Quebec Metropolitan, Québec, Canada - Centre Hospitalier Universitaire de Nice - Hôpital Archet 2, Nice, Alpes-maritimes, France - Chru de Brest - Hôpital Morvan, Brest, Finestère, France - Universitaetsklinikum Tübingen, Tübingen, Baden-Wurttemberg, Germany - Klinikum Rechts Der Isar, Technische Universität München, Munich, Bavaria, Germany - Universitätsklinikum Frankfurt Klinik Für Dermatologie, Venerologie Und Allergologie, Frankfurt am Main, Hesse, Germany - Fachklinik Bad Bentheim - Dermatologische Studienambulanz, Bad Bentheim, Lower Saxony, Germany - Dermatologische Studienambulanz, Bochum, North Rhine-Westphalia, Germany - University Hospital Muenster, Münster, North Rhine-Westphalia, Germany - Clinical Research Center for Hair and Skin Science, Dept of Dermatology, Charité Universitätsmedizin Berlin, Berlin, Germany - Universitätsklinikum Erlangen Hautklinik, Erlangen, Germany - Pécsi Tudományegyetem Klinikai Központ, Bőr-, Nemikórtani És Onkodermatológiai Klinika, Pécs, Baranya, Hungary - Szte Áok Szent-Györgyi Albert Klinikai Központ Bőrgyógyászati És Allergológiai Klinika, Szeged, Csongrád-csanád, Hungary - Bugát Pál Kórház, Gyöngyös, Heves County, Hungary - Semmelweis Egyetem, Általános Orvostudományi Kar, Bőr-, Nemikórtani És Bőronkológiai Klinika, Budapest, Pest County, Hungary - Wromedica I. Bielicka, A. Strzalkowska S.C., Wroclaw, Lower Silesian Voivodeship, Poland - Twoja Przychodnia - Centrum Medyczne Nowa Sól, Nowa Sól, Lubusz Voivodeship, Poland - Etg Siedlce, Siedlce, Masovian Voivodeship, Poland - Ot.Co Clinic Klinika Osipowicz & Turkowski Sp. Z O.O., Warsaw, Masovian Voivodeship, Poland - Rcmed Oddzial Warszawa, Warsaw, Masovian Voivodeship, Poland - Carpe Diem Centrum Medycyny Estetycznej, Warsaw, Masovian Voivodeship, Poland - Etg Warszawa, Warsaw, Masovian Voivodeship, Poland - Twoja Przychodnia - Szczecinskie Centrum Medyczne, Szczecin, Poland - Etg Skierniewice, Skierniewice, Łódź Voivodeship, Poland - Hospital Del Mar, Barcelona, Catalonia, Spain - Hospital Santa Creu I Sant Pau, Barcelona, Catalonia, Spain - Hospital Clinic de Barcelona, Barcelona, Spain - Hospital Universitario Reina Sofia, Córdoba, Spain - Hospital Universitario Ramón Y Cajal - Edificio Consultas Externas, Madrid, Spain - Hospital Doce de Octubre, Madrid, Spain - Hospital Universitario La Paz, Madrid, Spain - Hospital Universitario Infanta Leonor, Madrid, Spain ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `locations.metroboston clinical partners, llc|brighton|massachusetts|united states` — added _(2026-05-12)_ - `locations.clinical research institute of michigan, llc|chesterfield|michigan|united states` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.alliance dermatology & mohs center|phoenix|arizona|united states` — added _(2026-05-12)_ - `locations.johnson dermatology|fort smith|arkansas|united states` — added _(2026-05-12)_ - `locations.dermatology research associates|los angeles|california|united states` — added _(2026-05-12)_ - `locations.university of miami hospital|miami|florida|united states` — added _(2026-05-12)_ - `locations.floridian research institute llc|miami|florida|united states` — added _(2026-05-12)_ - `locations.hamzavi dermatology|fort gratiot|michigan|united states` — added _(2026-05-12)_ - `locations.galen research|chesterfield|missouri|united states` — added _(2026-05-12)_ - `locations.vivida dermatology|las vegas|nevada|united states` — added _(2026-05-12)_ - `locations.the dermatology group p.c.|verona|new jersey|united states` — added _(2026-05-12)_ - `locations.icahn school of medicine at mount sinai|new york|new york|united states` — added _(2026-05-12)_ - `locations.columbia university medical center - department of dermatology|new york|new york|united states` — added _(2026-05-12)_ - `locations.university of rochester|rochester|new york|united states` — added _(2026-05-12)_ - `locations.dermatologists of southwest ohio|mason|ohio|united states` — added _(2026-05-12)_ - `locations.oregon medical research|portland|oregon|united states` — added _(2026-05-12)_ - `locations.velocity clinical research - providence|warwick|rhode island|united states` — added _(2026-05-12)_ - `locations.the skin wellness center|knoxville|tennessee|united states` — added _(2026-05-12)_ - `locations.north texas center for clinical research|frisco|texas|united states` — added _(2026-05-12)_ - `locations.elixir research group|houston|texas|united states` — added _(2026-05-12)_ - `locations.progressive clinical research|san antonio|texas|united states` — added _(2026-05-12)_ - `locations.velocity clinical research/gateway|salt lake city|utah|united states` — added _(2026-05-12)_ - `locations.velocity clinical research/swinyer-woseth dermatology|salt lake city|utah|united states` — added _(2026-05-12)_ - `locations.jordan valley dermatology center|south jordan|utah|united states` — added _(2026-05-12)_ - `locations.the rector and visitors of the university of virginia|charlottesville|virginia|united states` — added _(2026-05-12)_ - `locations.care clinic ltd.|red deer|alberta|canada` — added _(2026-05-12)_ - `locations.medical arts health research group|kelowna|british columbia|canada` — added _(2026-05-12)_ - `locations.kingsway clinical research|etobicoke|ontario|canada` — added _(2026-05-12)_ - `locations.north bay dermatology centre|north bay|ontario|canada` — added _(2026-05-12)_ - `locations.the centre for dermatology|richmond hill|ontario|canada` — added _(2026-05-12)_ - `locations.centre de recherche saint-louis|québec||canada` — added _(2026-05-12)_ - `locations.centre de recherche dermatologique du quebec metropolitan|québec||canada` — added _(2026-05-12)_ - `locations.centre hospitalier universitaire de nice - hôpital archet 2|nice|alpes-maritimes|france` — added _(2026-05-12)_ - `locations.chru de brest - hôpital morvan|brest|finestère|france` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT04797650.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT04797650* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*