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.
במבט חטוף
על מה המחקר הזה?
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.
נקודות עיקריות
- 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.
מי עשוי להיות זכאי?
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.
האם מחקר זה יכול להתאים לך?
ענה על השאלות המהירות הללו כדי לבדוק אם אתה עשוי להיות זכאי. זהו מדריך בלבד — צוות המחקר מקבל את ההחלטה הסופית.
- האם אתה בין גיל 18 ל-65?
- 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?
מה כרוך בהשתתפות?
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.
סיכונים ותועלות פוטנציאליים
Locations (91)
- Total Skin and Beauty Dermatology Centerמיקוד מאומתבירמינגהם, ארצות הברית
- Alliance Dermatology & MOHS Centerמיקוד מאומתפניקס, ארצות הברית
- Center for Dermatology and Plastic Surgery/CCT Researchמיקוד מאומתסקוטסדייל, ארצות הברית
- Johnson Dermatologyמיקוד מאומתפורט סמית', ארצות הברית
- Northwest Arkansas Clinical Trials Center, PLLCמיקוד מאומתRogers, United States
- קרן מחקר בע"מ.מיקוד מאומתבייקרספילד, ארצות הברית
- Hope Clinical Researchמיקוד מאומתCanoga Park, United States
- California Dermatology & Clinical Research Instituteמיקוד מאומתEncinitas, United States
- University of California, Irvineמיקוד מאומתאירוויין, ארצות הברית
- Dermatology Research Associatesמיקוד מאומתלוס אנג'לס, ארצות הברית
- Quest Dermatology Researchמיקוד מאומתNorthridge, United States
- Kaiser Permanente Northern California - Oaklandמיקוד מאומתאוקלנד, ארצות הברית
שאלות נפוצות
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.
מה אם אחליט שאני לא רוצה להמשיך?
You are free to leave the study at any time, for any reason, without it affecting your usual medical care.
כיצד לגלות עוד
תמיד התייעץ עם רופא המשפחה או המומחה שלך לפני שתחליט להשתתף במחקר.
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