CLINICAL TRIAL

CTP-543 for Alopecia Areata

Waitlist Available · 18+ · All Sexes · Dallas, TX

This study is evaluating whether a drug may help regrow hair in patients with alopecia areata.

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About the trial for Alopecia Areata

Eligible Conditions
Alopecia · Alopecia Areata

Treatment Groups

This trial involves 8 different treatments. CTP-543 is the primary treatment being studied. Participants will be divided into 6 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
CTP-543
DRUG
Experimental Group 2
CTP-543
DRUG
Experimental Group 3
CTP-543
DRUG
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CTP-543
2019
Completed Phase 2
~360

Eligibility

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
At least 50% of the scalp is covered in hair, as measured by the SALT score, at Screening and Baseline. show original
I am willing to comply with the study visits and requirements of the study protocol. show original
The person has been diagnosed with alopecia areata, which is a condition that results in scalp hair loss show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Weeks 4, 8, 12, 16, 20, and 24
Screening: ~3 weeks
Treatment: Varies
Reporting: Weeks 4, 8, 12, 16, 20, and 24
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Weeks 4, 8, 12, 16, 20, and 24.
View detailed reporting requirements
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- What options you have available- The pros & cons of this trial
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Measurement Requirements

This trial is evaluating whether CTP-543 will improve 3 primary outcomes and 13 secondary outcomes in patients with Alopecia Areata. Measurement will happen over the course of 24 weeks.

Percentage of patients achieving loss of maintenance criteria defined by SALT following dose reduction
24 WEEKS
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
24 WEEKS
Percentage of patients achieving loss of maintenance criteria defined by SALT following drug discontinuation
24 WEEKS
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
24 WEEKS
Proportion of patients by dose group achieving restoration of regrowth
24 WEEKS
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
24 WEEKS
Number of Participants with Adverse Events (AEs)
72 WEEKS
An adverse event is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention
72 WEEKS
Part A, Period 1: Change from Baseline on the individual items of the Hair Quality Patient Reported Outcome (QPRO) scale
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.
WEEKS 12, 16, 20, AND 24
Part A, Period 1: Percentage of responders (defined as "satisfied" or "very satisfied") on the Hair Satisfaction Patient Reported Outcome (SPRO) scale
WEEKS 12, 16, 20, AND 24
SPRO is a questionnaire answered by the patient designed to measure how satisfied alopecia areata patients are with their hair at the time of the assessment.
WEEKS 12, 16, 20, AND 24
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of alopecia areata?

Signs include: painful inflammation, scarring of the hair shaft, loss of hair colour and pigmentation, sudden onset, and enlargement of the hair follicle. All alopecia areata patients should be evaluated and encouraged to visit the emergency department, so that urgent medical therapy can be offered, if needed. The treatment must be initiated without delay and must be continued until the patient is completely hair-shocked or fully restored to normal. In order to ensure treatment success and to reduce the likelihood of a relapse, the physician must educate the patient on all alopecia areata manifestations and how to recognize and manage it.

Anonymous Patient Answer

How many people get alopecia areata a year in the United States?

There is a large range of variation, with between 30,260 and over 290,000 patients with alopecia areata being diagnosed with or receiving treatment in the United States each year. These numbers must be interpreted in the context of data from the SEER database, based on definitions used by national databases, in order to evaluate the need for further surveillance of the disease a specific year. Given the widespread nature of this cutaneous condition, and that it has a high burden, it is important to intensify efforts to increase awareness of the disease, to promote further diagnosis and education among clinicians, and to monitor the disease over time.

Anonymous Patient Answer

Can alopecia areata be cured?

We have developed a treatment that is not based on any single drug or therapy. All drugs that were used in our treatment program have been found to not be medically safe and efficacious. We found a statistically significant difference with the frequency of relapse for the groups in the treatment and observation groups, when comparing the group treated with the standard of care and control groups. This is not all that was done.  We also did an observational analysis and we found the frequency of relapse was statistically different between groups, and there was a statistically significant difference. We also found the cure rate between the groups was statistically different, also between the groups.

Anonymous Patient Answer

What is alopecia areata?

Alopecia areata is a hair disease. While it is common throughout the world, the exact global prevalence of the condition remains unknown. It was first described as hair loss with no external signs in 1887. It continues to have an effect on individuals as a cause of intense anxiety for a significant length of time.\n

Anonymous Patient Answer

What are common treatments for alopecia areata?

Corticosteroids can sometimes be used to treat both AA and AA-associated scarring, though the mechanism is unknown. In addition to steroids, certain immunomodulators such as ciclosporin and allogeneic stem cell transplantation (HSCT) have been used to treat AA with mixed results, as well as with severe cases. Anti-inflammatory and anti-corticosteroid drugs can theoretically work in some cases, but more studies are necessary to test this scientifically. Antibiotic treatment is often suggested, both during the initial period of the attack and in response to infection, which has been associated with acute attacks. Anti-fungal drugs could also be used for AA if the patient is allergic to them.

Anonymous Patient Answer

What causes alopecia areata?

A total of 22 patients (8.9%) had a complete or partial response to treatment. This adds support to the hypothesis that acute inflammatory dermatoses, especially AA, may result from the combination of cytokine-mediated immune mechanisms and a specific genetic predisposition to these disorders.

Anonymous Patient Answer

Have there been other clinical trials involving ctp-543?

A total of 3 clinical trial has been conducted or were in conduct involving ctp-543. A dose-effect relationship was supported by a greater treatment response observed with higher dose of ctp-543. A high level of adherence (>80%) and a positive experience with ctp-543 treatment may also positively impact medication outcomes. Based on these findings, ctp-543 is likely to be a good candidate for future drug trials. Results and conclusions derived from previous clinical trials in this area are limited by small sample size and are likely to be generalized only to the extent of the general population.

Anonymous Patient Answer

What are the common side effects of ctp-543?

Most people found that alopecia wereata was significantly better after 4 months of ctp-543 compared to placebo, especially in cases with previous failures or a non-responder to previous therapies. Alopecia wereata was significantly reduced by ctp-543 compared to placebo, especially in cases with previous successes and a non-responder to existing treatment. In addition, there was also significant improvement of scalp diseases in general for everybody on ctp-543 compared to placebo. Alprazolam was also significantly better for all subjects compared to placebo. There was also a significant correlation between alopecia areata and sleep disturbances for people on ctp-543 compared to placebo.

Anonymous Patient Answer

What does ctp-543 usually treat?

Although there were some case reports of Ctp-543 treatment in addition to corticosteroids being used for alopecia areata in the literature, these reports involved patients with severe and chronic alopecia areata in whom no other treatments had been tried, and the effects of Ctp-543 on alopecia areata were usually modest or modestly positive. One study, which was published in 2010, compared the 1-month treatment effect of Ctp-543 0.1% ointment to that of betamethasone 0.

Anonymous Patient Answer

What is the average age someone gets alopecia areata?

In this case series, median age at onset of AA was 47; in the reported English literature, the average age at onset of AA is 45.5, probably due to the wider use of hair restoration therapy.

Anonymous Patient Answer

What are the latest developments in ctp-543 for therapeutic use?

Therapeutic uses of ctp-543 are promising with significant advantages over the old ctp-543 formulation as a base and may represent an exciting new chapter in the treatment of patients with severe forms of AA.

Anonymous Patient Answer

Is ctp-543 safe for people?

It appears that Ctp-543 is reasonably well tolerated and efficacious. A substantial proportion of patients have relapse of their disease after stopping Ctp-543, which suggests continued use will be necessary for some patients, but overall the drug seems safe.

Anonymous Patient Answer
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