Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA2)

Alopecia Areata Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04797650
• Other study ID #: CP543.3002
• Secondary ID: 2021-000387-30
• Status: Completed
• Phase: Phase 3
• Start date: June 10, 2021
• Est. completion date: June 29, 2022

Study information

• Verified date: June 2023
• Source: Concert Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 517
• Est. completion date: June 29, 2022
• Est. primary completion date: June 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• CTP-543 matching placebo
Administered as tablets.
• CTP-543
Administered as tablets.

Locations

Country	Name	City	State
Canada	Kingsway Clinical Research	Etobicoke	Ontario
Canada	Medical Arts Health Research Group	Kelowna	British Columbia
Canada	North Bay Dermatology Centre	North Bay	Ontario
Canada	Centre de Recherche Dermatologique du Quebec Metropolitan	Quebec
Canada	Centre de Recherche Saint-Louis	Quebec
Canada	Care Clinic Ltd.	Red Deer	Alberta
Canada	The Centre for Dermatology	Richmond Hill	Ontario
France	Chru de Brest - Hôpital Morvan	Brest	Finestère
France	Centre Hospitalier Universitaire de Nice - Hôpital Archet 2	Nice	Alpes-maritimes
Germany	Fachklinik Bad Bentheim - Dermatologische Studienambulanz	Bad Bentheim	Niedersachsen
Germany	Clinical Research Center for Hair and Skin Science, Dept of Dermatology, Charité Universitätsmedizin Berlin	Berlin
Germany	Dermatologische Studienambulanz	Bochum	Nordrhein-Westfalen
Germany	Universitätsklinikum Erlangen Hautklinik	Erlangen
Germany	Universitätsklinikum Frankfurt Klinik Für Dermatologie, Venerologie Und Allergologie	Frankfurt am main	Hessen
Germany	Klinikum Rechts Der Isar, Technische Universität München	Munich	Bayern
Germany	University Hospital Muenster	Münster	Nordrhein-westfalen
Germany	Universitaetsklinikum Tübingen	Tübingen	Baden-württemberg
Hungary	Semmelweis Egyetem, Általános Orvostudományi Kar, Bor-, Nemikórtani És Boronkológiai Klinika	Budapest	Pest
Hungary	Bugát Pál Kórház	Gyöngyös	Heves
Hungary	Pécsi Tudományegyetem Klinikai Központ, Bor-, Nemikórtani És Onkodermatológiai Klinika	Pécs	Baranya
Hungary	Szte Áok Szent-Györgyi Albert Klinikai Központ Borgyógyászati És Allergológiai Klinika	Szeged	Csongrád-csanád
Poland	Twoja Przychodnia - Centrum Medyczne Nowa Sól	Nowa Sól	Lubuskie
Poland	Etg Siedlce	Siedlce	Mazowieckie
Poland	Etg Skierniewice	Skierniewice	Lódzkie
Poland	Twoja Przychodnia - Szczecinskie Centrum Medyczne	Szczecin
Poland	Carpe Diem Centrum Medycyny Estetycznej	Warszawa	Mazowieckie
Poland	Etg Warszawa	Warszawa	Mazowieckie
Poland	Ot.Co Clinic Klinika Osipowicz & Turkowski Sp. Z O.O.	Warszawa	Mazowieckie
Poland	Rcmed Oddzial Warszawa	Warszawa	Mazowieckie
Poland	Wromedica I. Bielicka, A. Strzalkowska S.C.	Wroclaw	Dolnoslaskie
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Del Mar	Barcelona	Cataluña
Spain	Hospital Santa Creu I Sant Pau	Barcelona	Cataluña
Spain	Hospital Universitario Reina Sofia	Córdoba
Spain	Hospital Doce de Octubre	Madrid
Spain	Hospital Universitario Infanta Leonor	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Ramón Y Cajal - Edificio Consultas Externas	Madrid
United States	MetroBoston Clinical Partners, LLC	Brighton	Massachusetts
United States	The Rector and Visitors of the University of Virginia	Charlottesville	Virginia
United States	Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan
United States	Galen Research	Chesterfield	Missouri
United States	Hamzavi Dermatology	Fort Gratiot	Michigan
United States	Johnson Dermatology	Fort Smith	Arkansas
United States	North Texas Center for Clinical Research	Frisco	Texas
United States	Elixir Research Group	Houston	Texas
United States	The Skin Wellness Center	Knoxville	Tennessee
United States	Vivida Dermatology	Las Vegas	Nevada
United States	Dermatology Research Associates	Los Angeles	California
United States	Dermatologists of Southwest Ohio	Mason	Ohio
United States	Floridian Research Institute LLC	Miami	Florida
United States	University of Miami Hospital	Miami	Florida
United States	Columbia University Medical Center - Department of Dermatology	New York	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Alliance Dermatology & Mohs Center	Phoenix	Arizona
United States	Oregon Medical Research	Portland	Oregon
United States	University of Rochester	Rochester	New York
United States	Velocity Clinical Research/Gateway	Salt Lake City	Utah
United States	Velocity Clinical Research/Swinyer-Woseth Dermatology	Salt Lake City	Utah
United States	Progressive Clinical Research	San Antonio	Texas
United States	Jordan Valley Dermatology Center	South Jordan	Utah
United States	The Dermatology Group P.C.	Verona	New Jersey
United States	Velocity Clinical Research - Providence	Warwick	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Concert Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Hungary,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Score =20 at 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).	Week 24
Secondary	Percentage of Responders on the Hair Satisfaction Participants Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24	SPRO is a questionnaire answered by the participant and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment. The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied. Responders were defined as participants with responses of "satisfied" or "very satisfied".	Weeks 12, 16, 20, and 24
Secondary	Percentage of Participants Achieving an Absolute SALT Score of =20 at Weeks 4, 8, 12, 16, and 20	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).	Weeks 4, 8, 12, 16, and 20
Secondary	Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 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). Relative change (percent change) to baseline is calculated as: 100 x ([post-baseline SALT score - baseline SALT score]/baseline SALT score).	Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary	Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20, and 24	The CGI-I is a questionnaire that asks the clinician to evaluate the improvement or worsening of the participant's alopecia areata as compared to the start of the study on a 7-point scale. Responses range from 1 (very much worse) to 7 (very much improved). Responders were defined as participants with responses of 6 (much improved) or 7 (very much improved).	Weeks 12, 16, 20, and 24
Secondary	Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24	The PGI-I is a self-administered questionnaire that asks the participant to evaluate the improvement or worsening of their alopecia areata as compared to the start of the study on a 7-point scale. Responses range from 1 (very much worse) to 7 (very much improved). Responders were defined as participants with responses of 6 (much improved) or 7 (very much improved).	Weeks 12, 16, 20, and 24
Secondary	Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24	The CGI-S is a questionnaire that asks the clinician to evaluate the symptom severity of the participant's alopecia areata at the time of assessment. The symptom severity was rated on a scale ranging from 1 to 7, where 1=normal, no hair loss; 2=borderline hair loss; 3=mild hair loss; 4=moderate hair loss; 5=marked hair loss; 6=severe hair loss; 7=among the most extreme hair loss. Higher scores indicate more hair loss. A negative change from baseline indicates less hair loss.	Baseline, Weeks 12, 16, 20, and 24
Secondary	Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24	The PGI-S is a self-administered questionnaire that asks the participant to evaluate the symptom severity of their alopecia areata at the time of assessment. Symptom severity was rated on a scale ranging from 1 to 7, where 1= normal, no hair loss; 2= borderline hair loss; 3= mild hair loss; 4= moderate hair loss; 5= marked hair loss; 6= severe hair loss; 7= among the most extreme hair loss. Higher scores indicate more hair loss. A negative change from baseline indicates less hair loss.	Baseline, Weeks 12, 16, 20, and 24
Secondary	Percentage of Participants Achieving at Least a 75% and 90% Relative Reduction in SALT Score From Baseline at Weeks 12 and 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). Percentage of participants achieving at least a 75% and 90% relative reduction in SALT score from baseline at Weeks 12 and 24 are reported.	Baseline, Weeks 12, and 24
Secondary	Change in the Brigham Eyebrow Tool for Alopecia (BETA) Scores From Baseline at Weeks 12 and 24	BETA is a clinician-rated scale that assesses the total eyebrow hair present. The BETA score is calculated based on hair density and surface area of each individual eyebrow of the participant, ranging from 0 to 3, where 0= no eyebrow, 1= minimal eyebrow, 2= moderate eyebrow, and 3= normal eyebrow. The BETA score is the sum of the right and left eyebrow scores, ranging from 0 to 6. Higher scores indicate less hair loss of eyebrows. A positive change from baseline indicates less hair loss of eyebrows.	Baseline, Weeks 12, and 24
Secondary	Change in the Brigham Eyelash Tool for Alopecia (BELA) Scores From Baseline at Weeks 12 and 24	BELA is a clinician-rated scale that assesses the total eyelash hair present. The BELA is calculated based on distribution and grade values, ranging from 0 (no eyelashes) to 3 (full eyelashes). The BELA score is the sum of the individual scores for the left and right eyes, ranging from 0 to 6. Higher scores indicate less hair loss of eyelashes. A positive change from baseline indicates less hair loss of eyelashes.	Baseline, Weeks 12, and 24
Secondary	Change in the SPRO Scale From Baseline at Weeks 12, 16, 20, and 24	SPRO is a questionnaire answered by the participant and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment. The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied. Higher scores indicate the greater hair dissatisfaction. A negative change from baseline indicate the greater hair satisfaction.	Baseline, Weeks 12, 16, 20 and 24
Secondary	Percentage of Participants Achieving a =2-point Change From Baseline in the SPRO Scale at Weeks 12, 16, 20, and 24	SPRO is a questionnaire answered by the participants and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment. The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied.	Weeks 12, 16, 20, and 24
Secondary	Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24	The QPRO questionnaire provides additional details on key attributes of hair and helps provide context to the SPRO response. The individual items of QPRO are: Satisfied thickness hair coverage; Satisfied evenness hair coverage; How satisfied with your eyebrows; How satisfied with your eyelashes, scored on a scale ranging from 1 to 5 where 1=very satisfied, 2=satisfied, 3=neither satisfied nor dissatisfied, 4=dissatisfied, 5=very dissatisfied. Higher scores indicate the greater dissatisfaction on hair quality. A negative change from baseline indicate the greater satisfaction on hair quality.	Baseline, Weeks 12, 16, 20, and 24
Secondary	Change in the Anxiety and Depression Scale Scores of the Hospital Anxiety and Depression Scale (HADS) From Baseline at Week 24	HADS is questionnaire designed to assess anxiety and depression symptoms which is completed by participants. The questionnaire is comprised of two separate scales with a total of 14 items: A 7-item scale related to anxiety and 7-item scale related to depression. Each item within both scales is scored using a 4-point scale, ranging from 0 to 3 and the total scores in each scale can range from 0 to 21. Separate scores were created for anxiety and depression. A score between 0-7 is considered normal, 8-10 is mild, 11-14 is moderate, and >14 is severe anxiety or depression. Higher scores indicate greater severity. A negative change from baseline indicates less severity.	Baseline and Week 24
Secondary	Percentage of Participants Achieving an Absolute SALT Score of =10 at Week 24	SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).	Week 24