A Phase 2, randomized, double-blind, placebo-controlled, parallel group, 3-arm, multinational, multicenter, proof-of-concept study to evaluate the efficacy and safety of amlitelimab monotherapy by subcutaneous injection in adult participants with severe alopecia areata
This research study is investigating a new medication called amlitelimab for adults who have severe alopecia areata. Alopecia areata is a condition where the immune system mistakenly attacks hair follicles, leading to hair loss. The main goal of this study is to find out if amlitelimab helps hair grow back and if it is safe to use. Participants will receive either the new medicine or a 'dummy' treatment (placebo) by injection under the skin. Neither the participants nor their doctors will know who is getting which treatment. Researchers will carefully track changes in hair growth, especially on the scalp, and monitor for any side effects over 36 weeks. Your involvement could help us learn more about treating this condition.
En un coup d'œil
De quoi parle cette étude ?
This study is a research project designed to test a new medicine named amlitelimab for severe alopecia areata. Alopecia areata is a condition where your body's immune system, which normally fights off germs, mistakenly attacks your hair follicles. This can cause hair to fall out in patches, or in severe cases, all over your scalp, eyebrows, and eyelashes. The medicine, amlitelimab, is given as an injection under the skin.
The study is trying to find out two main things: first, if amlitelimab can help hair grow back for people with severe alopecia areata, and second, if it is a safe medicine to use. To get clear results, some participants will receive the actual medicine, while others will receive a 'placebo.' A placebo looks exactly like the medicine but doesn't contain any active ingredients. This helps researchers understand the true effects of the drug compared to no treatment at all.
This is a 'Phase 2' study, which means it’s an early stage of research where we are still learning about how effective the medicine is and what the right dose might be. The information gathered from this study will be crucial in deciding if this medicine should be tested in larger studies in the future, ultimately to explore if it could become a new treatment option for people living with severe alopecia areata.
Points clés
- This study is testing a new injection medicine, amlitelimab, for severe hair loss from alopecia areata.
- It aims to see if the medicine helps hair grow back and if it's safe for adults.
- Some participants will get the actual medicine, others a 'dummy' treatment (placebo).
- The study lasts about 36 weeks and involves regular clinic visits for checks.
- Your involvement could help future treatments for alopecia areata.
- La participation est volontaire, et vous pouvez vous retirer à tout moment.
Qui peut être éligible ?
To be considered for this study, you must be an adult, aged 18 or older. Both men and women are welcome to take part in this research.
The study is specifically looking for people with severe alopecia areata. This means your hair loss must be significant, affecting a large portion of your scalp. The medical team will use a special scoring system to check if your hair loss meets the study's requirements.
There might be other health conditions or medicines that would prevent you from joining, to ensure your safety. The study team will review your full medical history to see if this study is right for you.
Cet étude pourrait-elle vous convenir ?
Répondez à ces questions rapides pour voir si vous êtes éligible. Ceci est un guide uniquement — l'équipe de recherche prend la décision finale.
- Avez-vous 18 ans ou plus ?
- Do you have severe alopecia areata (significant hair loss)?
- Are you able to attend regular clinic appointments for about 9 months?
- Are you comfortable with receiving injections under the skin?
En quoi consiste la participation ?
If you decide to join this study, you will be in the study for about 36 weeks, which is roughly 8 to 9 months, plus follow-up visits. You would receive either the study medicine (amlitelimab) or a placebo, given as injections under the skin. You, and your study doctor, would not know which one you are receiving.
Over the course of the study, you would attend regular appointments at the study clinic. These visits would involve several assessments. Doctors and nurses would check your hair growth, especially on your scalp, eyebrows, and eyelashes, using special measurements. They would also ask you questions about how you feel and your quality of life. Additionally, you would have blood tests and other health checks to monitor your safety and how your body is reacting to the treatment. The research team will explain all the details of these visits before you agree to participate.
Risques et avantages potentiels
Emplacements (8)
- —Non vérifiéItalie
- —Non vérifiéPays-Bas
- —Non vérifiéTchéquie
- —Non vérifiéRoumanie
- —Non vérifiéAllemagne
- —Non vérifiéFrance
- —Non vérifiéEspagne
- —Non vérifiéBulgarie
Questions fréquentes
Qu'est-ce que l'alopécie areata ?
Alopecia areata is a condition where your immune system mistakenly attacks your hair follicles, causing hair to fall out, often in patches.
What is amlitelimab?
Amlitelimab is the new medicine being tested in this study. It's given by injection under the skin to see if it can help with hair regrowth.
Qu'est-ce qu'un placebo ?
A placebo is a 'dummy' treatment that looks like the active medicine but doesn't contain any drug. It helps researchers compare the real effects of the medicine.
Saurai-je si je reçois le médicament ou le placebo ?
No, neither you nor your study doctor will know whether you are receiving the active medicine or the placebo during the study.
Combien de temps durera l'étude ?
Your active participation in the study will last about 36 weeks, or roughly 8 to 9 months, plus any follow-up visits.
Comment en savoir plus
Parlez toujours à votre médecin généraliste ou spécialiste avant de décider de participer à une étude.
Intéressé à participer ?
Discussion
Discussion communautaire
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