Alopecia AreataPhase 2NCT03811912

Efficacy and Tolerability Study of Two Dose Regimens of CTP-543 in Adults With Alopecia Areata

A Phase 2 study testing CTP-543 in people with Alopecia Areata, run by Concert Pharmaceuticals at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the efficacy and tolerability of once-daily versus twice-daily dosing of CTP-543, in adult patients with chronic, moderate to severe alopecia areata. 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: 57 participants
Where: 10 sitesUnited States
Study dates: 21 Mar 2019to 21 Nov 2019
Phase: Phase 2
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

Definitive diagnosis of 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.
Clinical lab results within the normal range

Who cannot join

Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis on the scalp.
Treatment with systemic immunosuppressive medications or biologics.
Vaccination with herpes zoster vaccine or any live virus within 6 weeks of screening or during the study

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Investigative Site
Boston, Massachusetts, 02114
Investigative Site
Boston, Massachusetts, 02115
Investigative Site
Boynton Beach, Florida, 33472
Investigative Site
Fridley, Minnesota, 55432
Investigative Site
Irvine, California, 92697
Investigative Site
New Haven, Connecticut, 06519
Investigative Site
Portland, Oregon, 97210
Investigative Site
Portsmouth, New Hampshire, 03801
Investigative Site
San Francisco, California, 94118
Investigative Site
Winston-Salem, North Carolina, 27104

Other trials in United States

About this study

Official title: A Randomized Parallel-Group Study to Evaluate the Efficacy and Tolerability of Two Dosing Regimens of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

This study will evaluate the efficacy and tolerability of once-daily versus twice-daily dosing of CTP-543, in adult patients with chronic, moderate to severe alopecia areata.

Conditions: Alopecia Areata
Being tested: CTP-543, CTP-543 Matching Placebo
Medical subject headings: Alopecia Areata

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CTP-543Drug
CTP-543 administered as 8 mg tablet.
CTP-543 Matching PlaceboDrug
Administered as tablets to aid treatment masking.

Study groups in NCT03811912
Study group	Role	What they receive
CTP-543 8 mg BID	Experimental	Participants received 1 x 8 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, twice daily (BID) for 24 weeks. Receives: Drug: CTP-543; Drug: CTP-543 Matching Placebo
CTP-543 16 mg QD	Experimental	Participants received 16 mg (2 x 8 mg) CTP-543 tablets, once daily (QD) and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 24 weeks. Receives: Drug: CTP-543; Drug: CTP-543 Matching Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Relative Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24
The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Relative change (percent change) to baseline is calculated as: 100 x ([baseline SALT score - follow-up SALT score]/baseline SALT score).
Measured: Baseline, Week 24

Secondary outcomes (4)

Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline
The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Percentage of participants achieving at least a 50%, 75%, 90% relative reduction in SALT score from baseline at Weeks 4, 8, 12, 16, 20, and 24 are reported.
Measured: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Absolute Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24
The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Absolute change equals the difference in SALT measurements (baseline SALT score - follow-up SALT score).
Measured: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16 and 20
The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Relative change (percent change) to baseline is calculated as: 100 x ([baseline SALT score - follow-up SALT score]/baseline SALT score).
Measured: Baseline, Weeks 4, 8, 12, 16 and 20
Percentage of Participants With Change in Satisfaction of Hair Coverage
Participant satisfaction question was used to assess overall satisfaction with hair coverage, with responses ranging from 1 to 5, as follows: 1 (very dissatisfied), 2 (dissatisfied), 3 (somewhat satisfied), 4 (mostly satisfied), 5 (very satisfied). Higher scores indicate better satisfaction with hair coverage. The percentage of participants with change from Baseline to the Week 24 satisfaction level was reported as categories: satisfied to satisfied; satisfied to dissatisfied; dissatisfied to satisfied and dissatisfied to dissatisfied. Data is reported only for participants with change from Baseline in satisfaction level.
Measured: Baseline, Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Mar 201921 Nov 2019

First posted22 Jan 2019
Study start21 Mar 2019
Primary completion21 Nov 2019
Study completion21 Nov 2019

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.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03811912
Sponsor's protocol ID: CP543.2002
Status last verified: Nov 2022
First submitted: 18 Jan 2019
Last updated: 9 Dec 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
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RecruitingPhase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
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Real-World Effectiveness of Ritlecitinib in Alopecia Areata Patients in the US: A Retrospective Analysis Using EHR and Claims Data
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All Alopecia Areata trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Parallel-Group Study to Evaluate the Efficacy and Tolerability of Two Dosing Regimens of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata
ClinicalTrials.gov ID: NCT03811912
Acronym / sponsor ID: CP543.2002
Conditions: Alopecia Areata
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: Concert PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 21 Mar 2019 (actual)
Primary completion: 21 Nov 2019 (actual)
Study completion: 21 Nov 2019 (actual)
First posted: 22 Jan 2019 (actual)
Results: Posted 9 Dec 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will evaluate the efficacy and tolerability of once-daily versus twice-daily dosing of CTP-543, in adult patients with chronic, moderate to severe alopecia areata.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
CTP-543 8 mg BID	Experimental	Drug: CTP-543, Drug: CTP-543 Matching PlaceboParticipants received 1 x 8 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, twice daily (BID) for 24 weeks.
CTP-543 16 mg QD	Experimental	Drug: CTP-543, Drug: CTP-543 Matching PlaceboParticipants received 16 mg (2 x 8 mg) CTP-543 tablets, once daily (QD) and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 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)

Definitive diagnosis of 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.
Clinical lab results within the normal range

Key exclusion criteria (3 listed)

Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis on the scalp.
Treatment with systemic immunosuppressive medications or biologics.
Vaccination with herpes zoster vaccine or any live virus within 6 weeks of screening or during the study

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-543CTP-543 administered as 8 mg tablet.	Drug	CTP-543 16 mg QD, CTP-543 8 mg BID
CTP-543 Matching PlaceboAdministered as tablets to aid treatment masking.	Drug	CTP-543 16 mg QD, CTP-543 8 mg BID

Primary outcome

Relative Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24
Time frame: Baseline, Week 24
The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Relative change (percent change) to baseline is calculated as: 100 x ([baseline SALT score - follow-up SALT score]/baseline SALT score).

4 secondary outcomes

Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Absolute 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
Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16 and 20
Time frame: Baseline, Weeks 4, 8, 12, 16 and 20
Percentage of Participants With Change in Satisfaction of Hair Coverage
Time frame: Baseline, Week 24

Results and safety

Results posted to the registry on 9 Dec 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CTP-543 8 mg BID	29	25
CTP-543 16 mg QD	28	26

Primary outcome: Relative Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24

Time frame: Baseline, Week 24. Mean (Standard Deviation). Unit: percent change

Measure	CTP-543 8 mg BID n = 29	CTP-543 16 mg QD n = 28
Value	46.4 (38.21)	18.0 (32.32)

Population analysed: Efficacy Population included all participants who received study drug and had at least 1 post-treatment SALT assessment. Participants in the efficacy population were analyzed according to their randomized dosing regimen.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events: From first dose of study drug up to Week 28; All-cause mortality: Randomization up to Week 28. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CTP-543 8 mg BID	0 of 29 (0%)	23 of 29 (79.3%)	0 of 29
CTP-543 16 mg QD	0 of 28 (0%)	23 of 28 (82.1%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Alopecia Areata

Active, not recruitingPhase 3
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
Severe Alopecia Areata
RecruitingPhase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
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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.

Colleen E Hamilton, MS study director

Concert Pharmaceuticals, Inc.

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CTP-543 in people with Alopecia Areata, run by Concert Pharmaceuticals at 10 sites in United States.

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 3 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 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 9 Dec 2022). 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?

Relative Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 (time frame: Baseline, 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 NCT03811912.

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 9 Dec 2022.