Active not recruitingPHASE2, PHASE3INTERVENTIONAL

Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata

This research is an 'extension study', meaning it follows on from an earlier trial. Its main goals are to check how safe a medicine called CTP-543 is over a longer period and how well it continues to help with hair loss in adults. The study focuses on people aged 18 to 65 who have moderate to severe alopecia areata, a condition that causes patchy or complete hair loss. To be eligible, participants must have already completed 24 weeks of treatment in a previous study with CTP-543. Researchers want to understand the long-term effects of this treatment, including any side effects and its ongoing ability to encourage hair regrowth.

At a glance

Status

Active not recruiting

Phase

PHASE2, PHASE3

Sponsor

Sun Pharmaceutical Industries, Inc.

Enrolment target

1,000

Start

04 Apr 2019

Estimated completion

01 Jun 2027

Alopecia Areata

What is this study about?

This study is an important next step in understanding a new medicine called CTP-543, which is being developed to treat alopecia areata. Alopecia areata is a condition where your immune system mistakenly attacks your hair follicles, leading to various degrees of hair loss. This particular study is designed to see what happens over a longer time when people continue taking CTP-543.

The main aims are twofold: firstly, to monitor the safety of CTP-543 when used for extended periods. This means watching carefully for any side effects and understanding how they might change over time. Secondly, the study will assess how effectively CTP-543 continues to help with hair regrowth and prevent further hair loss in adults who have moderate to severe alopecia areata.

By collecting more long-term information, researchers hope to get a clearer picture of CTP-543’s overall benefits and risks. This extended research is crucial for understanding if it could become a widely available treatment for people living with this challenging condition.

Key takeaways

This study is for adults with moderate to severe alopecia areata aged 18-65.
You must have already completed a 24-week CTP-543 study to join this one.
The study aims to check the long-term safety and effectiveness of CTP-543.
You will receive regular medical checks and assessments during the study.
Certain scalp conditions or pregnancy would prevent you from joining.
Your participation is voluntary, and you can withdraw at any point.

Who may be eligible?

To join this study, you must be an adult aged between 18 and 65 years old. A very key requirement is that you must have already taken part in and successfully completed 24 weeks (about six months) of treatment in a previous CTP-543 study.

There are some reasons why you wouldn't be able to join. For example, if you have ongoing skin conditions on your scalp such as inflammation, psoriasis, or significant dandruff (seborrheic dermatitis) that needs treatment. Also, if you have had significant injuries to your scalp or certain untreated skin growths (actinic keratosis), you wouldn't be able to participate.

For women, if you are breastfeeding, pregnant, or planning to become pregnant during the study or within 30 days after taking your last dose of the study medicine, you cannot take part. Additionally, all participants must agree not to donate blood at any time during the study and for 30 days afterwards.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 65 years old?
Have you already completed 24 weeks of treatment in a previous CTP-543 study?
Are you free from active scalp conditions like psoriasis or significant inflammation?
If you are a woman, are you not pregnant, breastfeeding, or planning a pregnancy during the study and for 30 days after?
Are you able to agree not to donate blood during the study and for 30 days afterwards?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll continue to take the CTP-543 medicine, which you’ve already been taking. You will have regular visits to the study clinic where the research team will check your health, measure your hair growth, and ask about any side effects you might be experiencing. These visits will involve various assessments, which might include physical examinations, blood tests, and photographs of your scalp. The exact schedule of these visits and tests will be explained to you in detail by the study staff. You'll continue to be followed up for a period after your last dose of medication. The total commitment to the study will vary depending on the specific design of this extension, but generally, extension studies can last for several months to a few years.

Potential risks and benefits

Taking part in this study could potentially offer continued benefits regarding your hair loss from alopecia areata, as you would keep receiving the study medication. This might lead to further hair growth or maintenance of existing growth. However, as with any medication, there's always a possibility of experiencing side effects, some of which you may have already experienced in the previous study, or new ones could emerge over a longer period. The research team will monitor you closely for any health changes or side effects. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (91)

Total Skin and Beauty Dermatology Center
Verified postcode
Birmingham, United States
Alliance Dermatology & MOHS Center
Verified postcode
Phoenix, United States
Center for Dermatology and Plastic Surgery/CCT Research
Verified postcode
Scottsdale, United States
Johnson Dermatology
Verified postcode
Fort Smith, United States
Northwest Arkansas Clinical Trials Center, PLLC
Verified postcode
Rogers, United States
Kern Research Inc.
Verified postcode
Bakersfield, United States
Hope Clinical Research
Verified postcode
Canoga Park, United States
California Dermatology & Clinical Research Institute
Verified postcode
Encinitas, United States
University of California, Irvine
Verified postcode
Irvine, United States
Dermatology Research Associates
Verified postcode
Los Angeles, United States
Quest Dermatology Research
Verified postcode
Northridge, United States
Kaiser Permanente Northern California - Oakland
Verified postcode
Oakland, United States

Common questions

What is alopecia areata?

Alopecia areata is a common condition where the body's immune system attacks hair follicles, leading to patchy or complete hair loss on the scalp or body.

What is CTP-543?

CTP-543 is a medicine being tested to help treat hair loss in people with alopecia areata by calming down the overactive immune system.

Why is this an 'extension study'?

An extension study means it's a follow-up to an earlier trial. It allows researchers to gather more information on the medicine's safety and effectiveness over a longer time.

Will I get paid to be in the study?

The study information doesn't specify payment, but any travel costs or expenses related to your participation will usually be covered. You should ask the study team about this.

What if I decide I don't want to continue?

You are free to leave the study at any time, for any reason, without it affecting your usual medical care.