A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adult Participants With Severe Alopecia Areata
This study is testing a new medicine called amlitelimab for adults who have severe alopecia areata, a condition causing significant hair loss. The main goal is to find out if this new medicine is safe and if it helps hair regrow. Participants will be split into groups; some will receive amlitelimab, and others will get a placebo (a dummy treatment with no active medicine). This comparison helps researchers understand if the new medicine is actually working. The study is "double-blind," meaning neither the patients nor their doctors will know who is getting the real medicine. It's a key step to see if amlitelimab could become a new treatment option for severe alopecia areata.
Överblick
Vad handlar denna studie om?
This research study is about a new medicine called amlitelimab, and its potential to help people with severe alopecia areata. Alopecia areata is a condition where your immune system mistakenly attacks your hair follicles, leading to patches of hair loss, or in severe cases, loss of most or all scalp hair.
The study aims to understand two main things: first, if amlitelimab is safe to use, meaning it doesn't cause too many serious side effects. Second, it wants to see if the medicine is effective at encouraging hair regrowth in people who have lost a lot of their hair due to severe alopecia areata. By comparing the new medicine to a placebo (a treatment that looks the same but contains no active medicine), the scientists can get a clearer picture of whether amlitelimab is truly making a difference.
Finding new treatments for severe alopecia areata is very important because it can have a big impact on people's lives. If this study shows positive results, amlitelimab could eventually offer a new option for people living with this condition.
Viktiga punkter
- Tests a new medicine (amlitelimab) for severe alopecia areata.
- Compares the new medicine to a dummy treatment (placebo).
- Study lasts up to 3 years and 4 months, including follow-up.
- You will not know if you're getting the active medicine or placebo initially.
- Aims to find out if amlitelimab is safe and effective for hair regrowth.
- Participation involves regular clinic visits for assessments and injections.
Vem kan vara berättigad?
This study is looking for adults aged 18 or older who have been diagnosed with alopecia areata for at least six months. You need to have severe hair loss, meaning 50% or more of your scalp is affected, and this current hair loss episode should have started less than eight years ago. Your hair loss should also be stable, meaning you haven't seen a lot of new hair growth recently.
There are also some important reasons why you might not be able to join. For example, if you have other types of hair loss, such as male or female pattern baldness, or if you have certain other skin conditions like psoriasis or lupus that affect the scalp. Also, if you've recently used certain strong medications for your hair or immune system, you might not be able to take part.
To make sure the study results are clear, you'll need to be happy to keep a consistent hairstyle and hair care routine throughout the study. This includes avoiding certain hair treatments like weaves, extensions, or shaving your scalp before visits.
Kan denna studie passa dig?
Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.
- Är du 18 år eller äldre?
- Have you been diagnosed with alopecia areata for at least 6 months?
- Do you have severe hair loss (at least 50% of your scalp)?
- Did your current severe hair loss episode start less than 8 years ago?
- Are you willing to keep a consistent hairstyle and hair care routine?
- Do you have other types of hair loss (e.g., male/female pattern baldness)? (If yes, you may not be eligible)
- Do you have other significant skin conditions on your scalp like psoriasis or lupus? (If yes, you may not be eligible)
Vad innebär deltagande?
If you decide to take part in this study, you'll first have a screening period that lasts about 2 to 4 weeks. After that, you'll enter the first main part of the study, which lasts 36 weeks. During this time, you'll either receive the study medicine (amlitelimab) or a dummy treatment (placebo) through injections under your skin. Neither you nor your study doctor will know which one you're getting.
After these 36 weeks, if you wish, you might be able to join an optional 'open-label' period for another 104 weeks. In this part, everyone who joins will receive the actual study medicine. Once all treatment periods are over, there will be a 16-week safety follow-up. In total, the study could last up to 160 weeks (about three years).
You will need to attend up to 38 visits to the study clinic if you join the optional longer period. If you only complete the first 36-week part, you would have around 12 visits. During these visits, the study team will check your health, assess your hair loss, and see how you're responding to the treatment.
Potentiella risker och fördelar
Locations (74)
- Total Skin and Beauty Dermatology Center- Site Number : 8400018Verifierat postnummerBirmingham, USA
- First OC Dermatology- Site Number : 8400014Verifierat postnummerFountain Valley, United States
- Center for Dermatology Clinical Research- Site Number : 8400008Verifierat postnummerFremont, United States
- UC Irvine Healthcare - Gottschalk Medical Plaza- Site Number : 8400007Verifierat postnummerIrvine, USA
- Dermatology Research Associates - Los Angeles- Site Number : 8400015Verifierat postnummerLos Angeles, USA
- New Horizon Research Center- Site Number : 8400017Verifierat postnummerMiami, USA
- Dawes Fretzin Clinical Research- Site Number : 8400010Verifierat postnummerIndianapolis, USA
- Michigan Center for Research Company- Site Number : 8400016Verifierat postnummerClarkston, United States
- Joel Schlessinger, PC- Site Number : 8400021Verifierat postnummerOmaha, United States
- Icahn School of Medicine at Mount Sinai- Site Number : 8400003Verifierat postnummerNew York, USA
- DJL Clinical Research - Charlotte - Park Road- Site Number : 8400013Verifierat postnummerCharlotte, USA
- Cleveland Clinic- Site Number : 8400028Verifierat postnummerCleveland, USA
Vanliga frågor
What is alopecia areata?
Alopecia areata is a condition where your immune system attacks your hair follicles, causing hair loss on the scalp and sometimes other parts of the body.
Vad är en 'placebo'?
A placebo is a dummy treatment that looks just like the real medicine but contains no active ingredients. It helps researchers compare how well the new medicine works.
Kommer jag att veta om jag får den riktiga medicinen?
During the first part of the study, neither you nor your doctor will know if you're getting the active medicine or the placebo. This is called a 'double-blind' study.
Hur länge kommer jag att vara med i studien?
The study could last anywhere from about 52 weeks (approx one year) to up to 160 weeks (over three years), depending on whether you join the optional longer treatment period.
What does 'severe hair loss' mean in this study?
For this study, severe hair loss means you've lost at least 50% of the hair on your scalp due to alopecia areata.
Hur du får reda på mer
Prata alltid med din läkare eller specialist innan du bestämmer dig för att delta i en studie.
Diskussion
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