Alopecia AreataPhase 3THRIVE-AA1NCT04518995
Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA1)
A Phase 3 study testing CTP-543 in people with Alopecia Areata, run by Concert Pharmaceuticals at 72 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- CTP-543
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 706 participants
- Where
- 72 sitesin 5 countries
- Study dates
- 23 Nov 2020to 19 Apr 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
72 sites in 5 countries.
72 sites in 5 countries
United States47 sites
Kern Research, Inc.
Bakersfield, California, 93301
Bellaire Dermatology Associates
Bellaire, Texas, 77401
Bexley Dermatology Research
Bexley, Ohio, 43209
Total Skin and Beauty Dermatology Center
Birmingham, Alabama, 35205
Massachusetts General Hospital - Clinic
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Colorado Center for Dermatology and Skin Surgery
Centennial, Colorado, 80111
Clinical Research Center of the Carolinas
Charleston, South Carolina, 29407
Darst Dermatology
Charlotte, North Carolina, 28277
Dermatology Specialists of Charlotte
Charlotte, North Carolina, 28277
Denova Research
Chicago, Illinois, 60611
Northwestern Memorial Hospital, Department of Dermatology
Chicago, Illinois, 60611
Clarkston Skin Research
Clarkston, Michigan, 48346
Dermatology Treatment and Research Center
Dallas, Texas, 75230
Colorado Medical Research Center
Denver, Colorado, 80210
California Dermatology & Clinical Research Institute
Encinitas, California, 92024
Palmetto Clinical Trial Services
Fountain Inn, South Carolina, 29644
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Skin Laser and Surgery Specialists of NJ
Hackensack, New Jersey, 07601
Austin Institute for Clinical Research, Inc.
Houston, Texas, 77056
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
UC Irvine Dermatology Clinical Research Center
Irvine, California, 92697
Clinical Investigation Specialists, Inc.
Kenosha, Wisconsin, 53144
DS Research
Louisville, Kentucky, 40241
University of Minnesota Department of Dermatology
Minneapolis, Minnesota, 55455
DS Research
New Albany, Indiana, 47150
Yale University, Church Street Research Unit
New Haven, Connecticut, 06519
Sadick Research Group
New York, New York, 10075
Quest Dermatology Research
Northridge, California, 91324
Kaiser Permanente
Oakland, California, 94611
Qualmedica Research LLC
Owensboro, Kentucky, 42301
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, 78660
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168
Dermatology Associates Of Plymouth Meeting
Plymouth Meeting, Pennsylvania, 19462
Northwest Dermatology Institute
Portland, Oregon, 97210
Rhode Island Hospital
Providence, Rhode Island, 02903
West End Dermatology Associates
Richmond, Virginia, 23233
Kaiser Permanente South Sacramento
Sacramento, California, 95823
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229
Kaiser Permanente
San Francisco, California, 94118
Lenus Research & Medical Group, LLC
Sweetwater, Florida, 33172
Clinical Research Trials of Florida, Inc.
Tampa, Florida, 33607
Forward Clinical Trials Inc.
Tampa, Florida, 33624
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, 74136
PEAK Research
Upper Saint Clair, Pennsylvania, 15241
Wake Forest University Health Sciences, Department of Dermatology
Winston-Salem, North Carolina, 27157
Canada14 sites
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario, L4M 7G1
Dermatology Research Institute
Calgary, Alberta, T1Y 0B4
Kirk Barber Research
Calgary, Alberta, T2G 1B1
Guelph Dermatology Research
Guelph, Ontario, N1L 0B7
Dr Wei Jing Loo Medicine Professional Corporation
London, Ontario, N6H 5L5
Lynderm Research Inc.
Markham, Ontario, L3P 1X3
Innovaderm Research Inc. - Clinic
Montreal, Quebec, H2X 2V1
Dr. S. K. Siddha Medicine Professional Corporation
Newmarket, Ontario, L3Y 5G8
The Centre for Clinical Trials
Oakville, Ontario, L6J 7W5
JRB Research Inc.
Ottawa, Ontario, K1H 7X3
Enverus Medical Research
Surrey, British Columbia, V3V 0C6
Research Toronto
Toronto, Ontario, M4W 2N4
K. Papp Clinical Research Inc.
Waterloo, Ontario, N2J 1C4
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, R3M 3Z4
France5 sites
Hôpital Saint-André - Chu de Bordeaux
Bordeaux, New Aquitaine, 33075
Hôpital Saint-Louis - Gh de La Rochelle
La Rochelle, New Aquitaine, 17000
Hôpital La Timone-Dermatologie
Marseille, 13385
Hôpital Hotel Dieu - Chu de Nantes
Nantes, Pays de la Loire Region, 44093
Hôpital Saint Louis, Centre de Santé Sabouraud
Paris, 75010
Poland4 sites
Vita Longa Sp.Zo.O
Katowice, 40-748
SGD S.C.
Krakow, 31-147
My Clinic
Warsaw, 00-144
Royalderm Agnieszka Nawrocka
Warsaw, 02-962
Spain2 sites
Hospital Clínico Y Provincial de Barcelona
Barcelona, 8036
H. U. Ramón y Cajal
Madrid, 28034
About this study
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 (THRIVE-AA1)
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.
- Conditions
- Alopecia Areata
- Being tested
- CTP-543 matching placebo, CTP-543
- Keywords
- Alopecia, Hair loss, Hair disease, CTP-543
- Medical subject headings
- Alopecia Areata, Alopecia, Hair Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTP-543 matching placeboDrug
Administered as tablets.
CTP-543Drug
Administered as tablets.
CTP-543Drug
Administered as tablets.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | Participants received CTP-543 matched placebo tablets, orally, twice daily (BID) for up to 24 weeks. Receives: Drug: CTP-543 matching placebo |
| CTP-543 8 mg BID | Experimental | Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks. Receives: Drug: CTP-543 |
| CTP-543 12 mg BID | Placebo comparator | Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks. Receives: Drug: CTP-543 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Score of ≤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).
Measured: Week 24
Secondary outcomes (15)
Percentage of Responders on the Hair Satisfaction Patient 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".
Measured: Weeks 12, 16, 20, and 24
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).
Measured: Weeks 4, 8, 12, 16, and 20
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline, Weeks 12, and 24
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, 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.
Measured: Baseline, Weeks 12, and 24
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.
Measured: Baseline, Weeks 12, and 24
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
HADS is a 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.
Measured: Baseline and Week 24
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 in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start23 Nov 2020
- Primary completion19 Apr 2022
- Study completion19 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 706 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concert Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518995
- Sponsor's protocol ID
- CP543.3001
- Other IDs
- 2020-002704-40
- Acronym
- THRIVE-AA1
- Status last verified
- Apr 2023
- First submitted
- 16 Aug 2020
- Last updated
- 3 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
King B, Senna MM, Mesinkovska NA, Lynde C, Zirwas M, Maari C, Prajapati VH, Sapra S, Brzewski P, Osman L, Hanna S, Wiseman MC, Hamilton C, Cassella J. Efficacy and safety of deuruxolitinib, an oral selective Janus kinase inhibitor, in adults with alopecia areata: Results from the Phase 3 randomized, controlled trial (THRIVE-AA1). J Am Acad Dermatol. 2024 Nov;91(5):880-888. doi: 10.1016/j.jaad.2024.06.097. Epub 2024 Jul 23.
PubMed 39053611
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 (THRIVE-AA1)
- ClinicalTrials.gov ID
- NCT04518995
- Acronym / sponsor ID
- THRIVE-AA1 / CP543.3001
- Conditions
- Alopecia Areata
- Keywords
- Alopecia, Hair loss, Hair disease, CTP-543
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 706 participants (actual)
- Lead sponsor
- Concert PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 19 Apr 2022 (actual)
- Study completion
- 19 Apr 2022 (actual)
- First posted
- 19 Aug 2020 (actual)
- Results
- Posted 3 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Drug: CTP-543 matching placeboParticipants received CTP-543 matched placebo tablets, orally, twice daily (BID) for up to 24 weeks. |
| CTP-543 8 mg BID | Experimental | Drug: CTP-543Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks. |
| CTP-543 12 mg BID | Placebo comparator | Drug: CTP-543Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTP-543 matching placeboAdministered as tablets. | Drug | Placebo |
| CTP-543Administered as tablets. | Drug | CTP-543 8 mg BID |
| CTP-543Administered as tablets. | Drug | CTP-543 12 mg BID |
Primary outcome
Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Score of ≤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).
15 secondary outcomes
Percentage of Responders on the Hair Satisfaction Patient 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39053611King B, Senna MM, Mesinkovska NA, Lynde C, Zirwas M, Maari C, Prajapati VH, Sapra S, Brzewski P, Osman L, Hanna S, Wiseman MC, Hamilton C, Cassella J. Efficacy and safety of deuruxolitinib, an oral selective Janus kinase inhibitor, in adults with alopecia areata: Results from the Phase 3 randomized, controlled trial (THRIVE-AA1). J Am Acad Dermatol. 2024 Nov;91(5):880-888. doi: 10.1016/j.jaad.2024.06.097. Epub 2024 Jul 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
72 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CTP-543 in people with Alopecia Areata, run by Concert Pharmaceuticals at 72 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in United States, Canada, France, Poland, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Score of ≤20 at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04518995, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.