Clinical trial NCT04797650: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alopecia Areata
Keywords: Alopecia
Hair loss
Hair disease
CTP-543
Lead sponsor: Concert Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2021-03-15
Enrollment: 517
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 criteria: 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.

Primary outcomes:
measure: Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Score ≤20 at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Responders on the Hair Satisfaction Participants Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24
timeFrame: Weeks 12, 16, 20, and 24
measure: Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20
timeFrame: Weeks 4, 8, 12, 16, and 20
measure: Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20, and 24
timeFrame: Weeks 12, 16, 20, and 24
measure: Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24
timeFrame: Weeks 12, 16, 20, and 24
measure: Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24
timeFrame: Baseline, Weeks 12, 16, 20, and 24
measure: Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24
timeFrame: Baseline, Weeks 12, 16, 20, and 24
measure: Percentage of Participants Achieving at Least a 75% and 90% Relative Reduction in SALT Score From Baseline at Weeks 12 and 24
timeFrame: Baseline, Weeks 12, and 24
measure: Change in the Brigham Eyebrow Tool for Alopecia (BETA) Scores From Baseline at Weeks 12 and 24
timeFrame: Baseline, Weeks 12, and 24
measure: Change in the Brigham Eyelash Tool for Alopecia (BELA) Scores From Baseline at Weeks 12 and 24
timeFrame: Baseline, Weeks 12, and 24
measure: Change in the SPRO Scale From Baseline at Weeks 12, 16, 20, and 24
timeFrame: Baseline, Weeks 12, 16, 20 and 24
measure: Percentage of Participants Achieving a ≥2-point Change From Baseline in the SPRO Scale at Weeks 12, 16, 20, and 24
timeFrame: Weeks 12, 16, 20, and 24
measure: Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24
timeFrame: Baseline, Weeks 12, 16, 20, and 24
measure: Change in the Anxiety and Depression Scale Scores of the Hospital Anxiety and Depression Scale (HADS) From Baseline at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants Achieving an Absolute SALT Score of ≤10 at Week 24
timeFrame: Week 24
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Alliance Dermatology & Mohs Center
state: Arizona
city: Fort Smith
country: United States
facility: Johnson Dermatology
state: Arkansas
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: Miami
country: United States
facility: Floridian Research Institute LLC
state: Florida
city: Brighton
country: United States
facility: MetroBoston Clinical Partners, LLC
state: Massachusetts
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Chesterfield
country: United States
facility: Galen Research
state: Missouri
city: Las Vegas
country: United States
facility: Vivida Dermatology
state: Nevada
city: Verona
country: United States
facility: The Dermatology Group P.C.
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University Medical Center - Department of Dermatology
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Mason
country: United States
facility: Dermatologists of Southwest Ohio
state: Ohio
city: Portland
country: United States
facility: Oregon Medical Research
state: Oregon
city: Warwick
country: United States
facility: Velocity Clinical Research - Providence
state: Rhode Island
city: Knoxville
country: United States
facility: The Skin Wellness Center
state: Tennessee
city: Frisco
country: United States
facility: North Texas Center for Clinical Research
state: Texas
city: Houston
country: United States
facility: Elixir Research Group
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Salt Lake City
country: United States
facility: Velocity Clinical Research/Gateway
state: Utah
city: Salt Lake City
country: United States
facility: Velocity Clinical Research/Swinyer-Woseth Dermatology
state: Utah
city: South Jordan
country: United States
facility: Jordan Valley Dermatology Center
state: Utah
city: Charlottesville
country: United States
facility: The Rector and Visitors of the University of Virginia
state: Virginia
city: Red Deer
country: Canada
facility: Care Clinic Ltd.
state: Alberta
city: Kelowna
country: Canada
facility: Medical Arts Health Research Group
state: British Columbia
city: Etobicoke
country: Canada
facility: Kingsway Clinical Research
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatology Centre
state: Ontario
city: Richmond Hill
country: Canada
facility: The Centre for Dermatology
state: Ontario
city: Quebec
country: Canada
facility: Centre de Recherche Saint-Louis
city: Quebec
country: Canada
facility: Centre de Recherche Dermatologique du Quebec Metropolitan
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice - Hôpital Archet 2
state: Alpes-maritimes
city: Brest
country: France
facility: Chru de Brest - Hôpital Morvan
state: Finestère
city: Tübingen
country: Germany
facility: Universitaetsklinikum Tübingen
state: Baden-württemberg
city: Munich
country: Germany
facility: Klinikum Rechts Der Isar, Technische Universität München
state: Bayern
city: Frankfurt am main
country: Germany
facility: Universitätsklinikum Frankfurt Klinik Für Dermatologie, Venerologie Und Allergologie
state: Hessen
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim - Dermatologische Studienambulanz
state: Niedersachsen
city: Bochum
country: Germany
facility: Dermatologische Studienambulanz
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: University Hospital Muenster
state: Nordrhein-westfalen
city: Berlin
country: Germany
facility: Clinical Research Center for Hair and Skin Science, Dept of Dermatology, Charité Universitätsmedizin Berlin
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen Hautklinik
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem Klinikai Központ, Bőr-, Nemikórtani És Onkodermatológiai Klinika
state: Baranya
city: Szeged
country: Hungary
facility: Szte Áok Szent-Györgyi Albert Klinikai Központ Bőrgyógyászati És Allergológiai Klinika
state: Csongrád-csanád
city: Gyöngyös
country: Hungary
facility: Bugát Pál Kórház
state: Heves
city: Budapest
country: Hungary
facility: Semmelweis Egyetem, Általános Orvostudományi Kar, Bőr-, Nemikórtani És Bőronkológiai Klinika
state: Pest
city: Wrocław
country: Poland
facility: Wromedica I. Bielicka, A. Strzalkowska S.C.
state: Dolnośląskie
city: Nowa Sól
country: Poland
facility: Twoja Przychodnia - Centrum Medyczne Nowa Sól
state: Lubuskie
city: Siedlce
country: Poland
facility: Etg Siedlce
state: Mazowieckie
city: Warszawa
country: Poland
facility: Ot.Co Clinic Klinika Osipowicz & Turkowski Sp. Z O.O.
state: Mazowieckie
city: Warszawa
country: Poland
facility: Rcmed Oddzial Warszawa
state: Mazowieckie
city: Warszawa
country: Poland
facility: Carpe Diem Centrum Medycyny Estetycznej
state: Mazowieckie
city: Warszawa
country: Poland
facility: Etg Warszawa
state: Mazowieckie
city: Szczecin
country: Poland
facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne
city: Skierniewice
country: Poland
facility: Etg Skierniewice
state: Łódzkie
city: Barcelona
country: Spain
facility: Hospital Del Mar
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Santa Creu I Sant Pau
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Madrid
country: Spain
facility: Hospital Universitario Ramón Y Cajal - Edificio Consultas Externas
city: Madrid
country: Spain
facility: Hospital Doce de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
Study officials:
References: