B7981110 A Phase 3, randomized, double blind, placebo controlled study to investigate the safety and efficacy of ritlecitinib in adult and adolescent participants 12 years of age and older with moderate alopecia areata
Alopecia areata is a condition where the body's immune system mistakenly attacks hair follicles, leading to patchy hair loss on the scalp. This Phase 3 clinical study is testing whether an experimental medicine called ritlecitinib can safely help hair grow back in people with moderate hair loss. Participants will take either the study medicine or a dummy pill (placebo) each day. Neither the participants nor their doctors will know who receives the active medicine until the study ends, ensuring results are completely fair. Over 24 weeks, doctors will monitor hair regrowth using a standard scalp measurement tool, alongside regular health checks. Taking part helps researchers discover if this tablet could become an effective new treatment for people living with hair loss. The study also gathers vital information on any potential side effects.
De un vistazo
¿De qué trata este estudio?
Alopecia areata is an autoimmune condition that causes hair to fall out in round or oval patches. In everyday health, your immune system defends you against germs like viruses and bacteria. In alopecia, however, immune cells mistakenly target healthy hair roots. This inflammation makes the hair shed and stops new strands from growing normally, which can be distressing and unpredictable to live with.
Ritlecitinib is a modern medicine designed to calm down the specific chemical signals that tell the immune system to attack hair follicles. By reducing this inflammation, researchers hope the hair roots can rest and restart their natural growth cycle. This trial is a Phase 3 study, which means the drug has already passed early safety tests and is now being tested in a larger group of people to confirm how well it works compared to a placebo.
Finding reliable treatments for alopecia areata is very important. Current options do not work for everyone, and hair often falls out again once treatments stop. If this study shows that ritlecitinib is both safe and effective, it could help bring a new, licensed treatment option to people struggling with hair loss in the future.
Puntos clave
- Tests whether ritlecitinib can safely regrow scalp hair in moderate alopecia areata.
- Compares the active medicine against a dummy pill (placebo) over 24 weeks.
- Requires taking a daily tablet and attending regular clinic appointments.
- Includes scalp checks, blood tests, and progress photos to monitor results.
- Participation is completely voluntary and you can withdraw at any time.
¿Quién puede ser elegible?
This study is designed for adults and young people who have moderate alopecia areata. To take part, you must have active patchy hair loss on your scalp that fits the study's specific measurement criteria. Both men and women can join.
You may not be eligible if your hair loss is caused by something else, such as scarring, male-pattern baldness, or stress-related shedding. People with certain serious medical conditions, recent severe infections, or those taking other immune-suppressing medicines might also be excluded for safety reasons.
If you are pregnant, planning a pregnancy, or breastfeeding, you will not be able to participate. The study team will review your full medical history and carry out a thorough health check to make sure the trial is completely safe for you.
¿Podría este estudio ser adecuado para ti?
Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.
- I have been diagnosed with moderate patchy hair loss (alopecia areata).
- I am aged 18 or older (or meet the adolescent age criteria at participating centres).
- I do not have other scalp conditions that cause scarring or permanent hair loss.
- I am not currently pregnant or breastfeeding.
- I am willing and able to attend clinic appointments over a 6-month period.
¿En qué consiste la participación?
Taking part in this trial involves taking a tablet once a day for about 24 weeks (roughly six months). Because this is a 'placebo-controlled' study, you will have an equal chance of receiving either the active medicine (ritlecitinib) or a dummy pill with no active ingredients.
You will need to attend regular hospital appointments so doctors can track your progress. These clinic visits typically happen at the start and then around weeks 8, 12, 18, and 24. During each visit, the medical team will examine your scalp, take standard medical photographs to measure hair regrowth, check your vital signs, and collect blood and urine samples.
You will also be asked to complete short questionnaires about how your hair loss affects your daily life and whether you notice an improvement. The overall commitment lasts around six months, plus a brief follow-up period to check on your health after you stop taking the study tablets.
Riesgos y beneficios potenciales
Ubicaciones (2)
- —No verificadoPolonia
- —No verificadoFrancia
Preguntas comunes
What is a placebo and why is it used?
A placebo is a dummy pill that looks identical to the real medicine but contains no active ingredients. It helps researchers prove whether any hair regrowth is truly caused by the study drug rather than chance.
Will I definitely receive the real medicine?
No. A computer will randomly choose whether you get ritlecitinib or the placebo. Neither you nor your study doctor can choose or know which one you are taking during the study.
Will taking part cost me anything?
No, the study medication and all trial-related appointments and tests are provided free of charge. Many trials also offer help with travel expenses.
Can I leave the study early if I change my mind?
Yes, taking part is entirely voluntary. You can leave the trial at any point without giving a reason, and it will not change the standard medical care you receive.
Is ritlecitinib already available from my GP?
Ritlecitinib is being evaluated in clinical studies and may have limited availability depending on current NHS approvals. Clinical trials are one way people can access it while researchers gather more evidence.
Cómo obtener más información
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
Discusión
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Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.