AuthorisedTherapeutic confirmatory (Phase III)Interventional

B7981028 - A LONG-TERM, DOUBLE-BLIND EXTENSION STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF RITLECITINIB IN PARTICIPANTS WITH SEVERE ALOPECIA AREATA WHO PREVIOUSLY COMPLETED STUDIES B7981027 OR B7981031

This study is a long-term follow-up for people with severe alopecia areata, a condition where the immune system attacks hair follicles, causing hair loss. Participants previously took part in earlier studies about a medicine called ritlecitinib. The main aim of this new study is to continue carefully watching how safe ritlecitinib is over a longer period. Researchers will also be checking how well it works to help hair regrow and improve other aspects of life that can be affected by alopecia areata. This includes looking at hair on the scalp, eyebrows, and eyelashes, and understanding how participants feel about their condition and their general mood and thinking skills. Some participants might receive the active medicine, while others might receive a matching dummy pill (placebo) for comparison.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Pfizer Inc.

Enrolment target

Start

14 Oct 2025

Alopecia areata

What is this study about?

This study, called B7981028, is a crucial step in understanding the long-term effects of a medicine named ritlecitinib for people with severe alopecia areata. Alopecia areata is a condition where the body's immune system mistakenly attacks hair follicles, leading to hair loss on the scalp and sometimes other parts of the body. This particular study is designed for individuals who have already participated in earlier studies (B7981027 or B7981031) on the same medicine. It’s an extension, meaning it allows researchers to continue monitoring these participants over a longer period than the initial studies.

The main purpose of this research is to gather more information on the safety of ritlecitinib when taken for an extended time. The researchers will be closely watching for any side effects and how often they occur. They will also assess how effective the medicine continues to be in helping hair regrow on the scalp, eyebrows, and eyelashes. Beyond just hair, the study will also look at how the medicine impacts a person's overall quality of life, their mood, and even their thinking abilities, as these can sometimes be affected by living with alopecia areata.

By carefully collecting this data over time, the researchers hope to get a clearer picture of whether ritlecitinib is a safe and helpful long-term treatment option for severe alopecia areata. This kind of research is really important because it helps doctors and patients make informed decisions about future treatments and ensures that new medicines are thoroughly understood before they become widely available.

Key takeaways

This study is for people who previously participated in specific ritlecitinib trials for severe alopecia areata.
It's a long-term study focusing on the safety and effectiveness of ritlecitinib.
The study will check hair regrowth on the scalp, eyebrows, and eyelashes.
Researchers will also look at how the medicine affects mood and overall well-being.
Regular clinic visits and health checks will be part of the study.

Who may be eligible?

This study is for people who have severe alopecia areata, a condition that causes hair loss. A key requirement is that you must have already taken part in one of the previous studies about ritlecitinib, specifically studies B7981027 or B7981031.

Anyone of any age or sex who meets this main requirement and others not mentioned here will be considered. The study is open to both males and females.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have severe alopecia areata?
Did I participate in study B7981027 or B7981031 for ritlecitinib?
Am I willing to attend regular clinic visits?
Am I willing to take study medication and complete assessments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will continue to receive either the study medicine, ritlecitinib, or a dummy pill (placebo) that looks exactly the same. The study is "double-blind," which means neither you nor your study doctor will know whether you are receiving the active medicine or the placebo. This helps to ensure the results are as fair and unbiased as possible. Over time, all participants in the study will eventually receive the active medicine.

You will have regular visits to the clinic, where the study team will perform various assessments. These will include checking your general health and looking at your hair loss to see if the treatment is helping. They'll measure how much hair has regrown on your scalp, eyebrows, and eyelashes. You'll also be asked to complete questionnaires about how you feel, your mood, and your daily life, to help understand the overall impact of the treatment. The total duration of your involvement could be several years.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. You might benefit from receiving a medicine that could help with your alopecia areata, or you might help others in the future by contributing to medical knowledge. However, as with any medicine, ritlecitinib can have side effects, and some participants will receive a placebo for a period. The study team will carefully monitor your health throughout. You have the right to withdraw from the study at any time, for any reason, without affecting your regular medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy
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Unverified
France
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Unverified
Czechia
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Unverified
Poland
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Unverified
Spain

Common questions

What is alopecia areata?

Alopecia areata is a condition where your immune system mistakenly attacks your hair follicles, leading to hair loss on your scalp and sometimes other parts of your body.

What is ritlecitinib?

Ritlecitinib is a medicine being studied for treating alopecia areata. This study is looking at its long-term safety and how well it helps hair regrow.

Why is it called a 'double-blind' study?

Double-blind means that neither you nor your study doctor will know whether you are receiving the active medicine or a dummy pill (placebo). This helps make the study results more reliable.

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active drug. It's used for comparison to see the true effects of the medicine.

What will happen if I join this study?

You will receive either ritlecitinib or a placebo, have regular clinic visits, and complete questionnaires. Your health and hair regrowth will be carefully monitored over a long period.