Aktiv, aber nicht rekrutierendPHASE2, PHASE3INTERVENTIONELL

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.

Auf einen Blick

Status

Aktiv, aber nicht rekrutierend

Phase

PHASE2, PHASE3

Sponsor

Sun Pharmaceutical Industries, Inc.

Einschreibeziel

1,000

Starten

04 Apr 2019

Geschätzte Fertigstellung

01. Juni 2027

Alopecia Areata

Worum geht es in dieser Studie?

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.

Wichtige Erkenntnisse

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.

Wer könnte berechtigt sein?

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.

Könnte diese Studie für Sie geeignet sein?

Beantworten Sie diese kurzen Fragen, um zu sehen, ob Sie möglicherweise berechtigt sind. Dies ist nur ein Leitfaden – das Forschungsteam trifft die endgültige Entscheidung.

Sind Sie zwischen 18 und 65 Jahre alt?
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?

Beantworten Sie jede Frage, um Ihr Ergebnis zu sehen.

Was beinhaltet die Teilnahme?

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.

Potenzielle Risiken und Vorteile

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.

Standorte (91)

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

Häufige Fragen

Was ist 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.

Werde ich für die Teilnahme an der Studie bezahlt?

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.

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