A Phase 3 Study to Evaluate the Efficacy and Safety of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

  • STATUS
    Recruiting
  • End date
    Mar 15, 2022
  • participants needed
    700
  • sponsor
    Concert Pharmaceuticals
Send
Updated on 15 January 2021
See if I qualify
Investigator
Colleen E Hamilton, MS
Primary Contact
Kaiser Permanente (9.6 mi away) Contact
+57 other location

Summary

This is a multi-center Phase 3 study to evaluate 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. The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). It is double-blinded, meaning that the Sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.

Details
Treatment CTP-543, 8 mg BID, CTP-543, 12 mg BID, Placebo, BID
Clinical Study IdentifierNCT04518995
SponsorConcert Pharmaceuticals
Last Modified on15 January 2021

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.

Eligibility

 Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 65 yrs?
Gender: Male or Female
Do you have any of these conditions: Alopecia Areata or areata alopecia or Alopecia or Hair Loss or Male Pattern Baldness?
Do you have any of these conditions: Alopecia or Male Pattern Baldness or Alopecia Areata or areata alopecia or Hair Loss?
Do you have any of these conditions: Hair Loss or areata alopecia or Male Pattern Baldness or Alopecia or Alopecia Areata?
Do you have any of these conditions: areata alopecia or Hair Loss or Alopecia or Male Pattern Baldness or Alopecia Areata?
Do you have any of these conditions: Male Pattern Baldness or Hair Loss or areata alopecia or Alopecia or Alopecia Areata?
Do you have any of these conditions: Alopecia or Male Pattern Baldness or areata alopecia or Hair Loss or Alopecia Areata?
Do you have any of these conditions: areata alopecia or Alopecia or Hair Loss or Male Pattern Baldness or Alopecia Areata?
Do you have any of these conditions: Alopecia Areata or Hair Loss or areata alopecia or Alopecia or Male Pattern Baldness?
Do you have any of these conditions: Alopecia or Alopecia Areata or Male Pattern Baldness or areata alopecia or Hair Loss?
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 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
Clear my responses
Read more

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.
Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more
Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more
Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study

user name
Edit Delete

Annotated by • 

 • 

Private

Edit Delete

Reply by • • Private
Edit Delete

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No made yet