CTP-543, 12 mg BID for Alopecia

Phase-Based Estimates
2
Effectiveness
3
Safety
Hospital Del Mar, Barcelona, Spain
Alopecia+1 More
CTP-543, 12 mg BID - Drug
Eligibility
18+
All Sexes
Eligible conditions
Alopecia

Study Summary

This study is evaluating whether a drug can help people with alopecia areata.

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Eligible Conditions

  • Alopecia
  • Alopecia Areata

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether CTP-543, 12 mg BID will improve 1 primary outcome and 16 secondary outcomes in patients with Alopecia. Measurement will happen over the course of Week 24.

Week 24
Change from Baseline in the anxiety scale of the Hospital Anxiety and Depression Scale
Change from Baseline in the depression scale of the Hospital Anxiety and Depression Scale (HADS)
Percentage of patients achieving an absolute SALT score of ≤10
Percentage of patients achieving an absolute Severity of Alopecia Tool (SALT) score ≤20
Percentage of responders (defined as "satisfied" or "very satisfied") on the Hair Satisfaction Patient Reported Outcome (SPRO)
Weeks 12 and 24
Change from Baseline on an eyebrow score
Change from Baseline on an eyelash score
Percentage of patients achieving at least a 75% relative reduction in SALT score from Baseline
Percentage of patients achieving at least a 90% relative reduction in SALT score from Baseline
Week 12
Change from Baseline in the CGI-S
Change from Baseline in the PGI-S
Change from Baseline on the individual items of the Hair Quality Patient Reported Outcome (QPRO) scale
Percentage of responders (defined as "much improved" or "very much improved") using the CGI-I
Percentage of responders (defined as "much improved" or "very much improved") using the PGI-I
Week 12
Percentage of patients achieving an absolute SALT score of ≤20
Percentage of responders (defined as "satisfied" or "very satisfied") on the Hair Satisfaction Patient Reported Outcome scale
Week 4
Relative change in SALT scores from Baseline

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

3 Treatment Groups

Placebo, BID
CTP-543, 8 mg BID
Placebo group

This trial requires 517 total participants across 3 different treatment groups

This trial involves 3 different treatments. CTP-543, 12 Mg BID is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

CTP-543, 8 mg BID
Drug
Oral tablet for 24 weeks
CTP-543, 12 mg BID
Drug
Oral tablet for 24 weeks
Placebo, BID
Drug
Oral tablet for 24 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CTP-543, 8 mg BID
2020
Completed Phase 3
~710
CTP-543, 12 mg BID
2020
Completed Phase 3
~710

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: weeks 4, 8, 12, 16, 20, and 24
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly weeks 4, 8, 12, 16, 20, and 24 for reporting.

Closest Location

Medical Arts Health Research Group - Kelowna, Canada

Eligibility Criteria

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.

Mark “yes” if the following statements are true for you:
The person has hair loss that is similar to alopecia areata, but the hair loss has been going on for at least 6 months and has not lasted more than 10 years show original
At least 50% of the scalp hair is lost, as measured by the SALT score, at the Screening and Baseline visits. show original
Eager to participate in the study and comply with all of the study's requirements. show original

Patient Q&A Section

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

Can alopecia be cured?

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Alopecia can be cured in some individuals. Further studies are necessary that evaluate alopecia remission and improvement in other patients and those at high risk of developing and maintaining alopecia for long-term maintenance.

Unverified Answer

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

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Estimates of the number of people affected by AA range from 1.3–15.5 million annually in the United States. The highest estimates are from the US. The magnitude of the estimates suggest that AA should probably receive heightened clinical and research attention.

Unverified Answer

What is alopecia?

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Alopecia is a common problem for men, affects more than half of the population and can be associated with psychological distress. The most common form of alopecia seen in older men is a form called androgenetic alopecia. Androgenic hair loss can be treated with steroidal ornon steroidal hair products. The primary cause of androgenic hair loss in men is chronic androgen exposure due to low levels of testosterone in their blood. The most common form of hair loss seen in older men is the baldness seen with age. There is no effective treatment for the majority of hair loss. Men over the age of 65 are more likely to develop the condition.

Unverified Answer

What are common treatments for alopecia?

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There are not many common treatments for alopecia, and the use of the medications, 5-alpha-reductase inhibitors and androgen depletion for the treatment of this condition remains controversial. However, hair loss can be induced using topical corticosteroids, hair growth in androgenic azoospermia can be restored using the combination of topical ciclosporin and topical retinoids in the treatment of both male and female androgenic alopecia. There is a significant need for more information for the diagnosis and treatment of androgen-mediated male and female hair loss.

Unverified Answer

What causes alopecia?

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The cause of alopecia is not fully understood and it is in part due to the fact that it lacks a standard diagnostic tool. The main causes associated to Alopecia are: alopecia areata, lichen planus, frontal fibrosing alopecia, congenital disorders such as Wiskott-Aberstein syndrome, dyskeratosis congenita, trichilemmomas and immunodeficiency disorders. It is also important to assess the presence of other signs and symptoms, and whether they are indicative of a disorder.

Unverified Answer

What are the signs of alopecia?

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Alopecia affects a patient's appearance, affects their self-esteem and makes them feel ashamed for their condition. The appearance of the patient with alopecia is a sign of hair loss and follicles are the main cause for hair loss.

Unverified Answer

Does alopecia run in families?

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Previous reports have suggested a genetic or heritable basis for at least some forms of congenital androgenic alopecia, and our study seems to further support this link. The use of a sensitive and reliable genetic method such as linkage analysis seems to be the appropriate next step in the elucidation of the cause of androgenic alopecia and its many associations in the population.

Unverified Answer

Has ctp-543, 12 mg bid proven to be more effective than a placebo?

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CTP-543 12 mg bid was not more effective than placebo in this study. In a recent study, findings were inconsistent, with most patients not achieving meaningful improvements in the scalp hair density parameter. Further development of CTP-543 12 mg bid for the treatment of CTP-543-induced HRT failure may prove worthwhile, and may represent a viable alternative to existing treatments for patients with chronic alopecia.

Unverified Answer

Who should consider clinical trials for alopecia?

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It would be difficult to determine which patients are eligible to be in clinical trials because, although the number of patients in a clinical trial may be small, and the study is unlikely to be large enough to confirm a statistical difference, enrollment of patients in the study is often based on a statistical likelihood of a difference between the groups being examined. While clinical trials may add important information to the current understanding of medicine, the results should be interpreted cautiously and used for only the most compelling indications. It is recommended that future clinical trials on alopecia should use appropriate measures for enrolling patients and be conducted on the basis of the strongest available evidence for a given therapeutic intervention.

Unverified Answer

What is the average age someone gets alopecia?

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It is likely that the age of onset is relatively delayed in men. We need to establish an earlier average age of onset for women.

Unverified Answer

What is ctp-543, 12 mg bid?

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CCP-543 is an effective treatment for women with CTLX, and the results were well tolerated with no significant changes to menstruation, or QTc interval, in clinical trials.

Unverified Answer

What are the common side effects of ctp-543, 12 mg bid?

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The side effects observed up to week 12 were usually mild and of minimal relevance, except for one woman who had slight vertigo and mild sweating. In addition to the side effects listed above, one patient complained of 'feeling as though the world was collapsing'. A majority of patients experienced some side effect. Therefore, it is important that side effects of ctp-543 are appropriately reported and evaluated by the patient and their physician following treatment with ctp-543.

Unverified Answer
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