RecruitingOBSERVATIONAL

Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib

This study is about a new medicine called Ritlecitinib for a condition called alopecia areata. Alopecia areata causes hair loss on the scalp and sometimes other parts of the body. Ritlecitinib has been approved in several countries for severe alopecia areata in people 12 years and older. While earlier studies showed positive results, this new study will look at how Ritlecitinib works for patients in real-world situations, rather than in a controlled trial. Researchers want to understand more about the people who use Ritlecitinib, their treatment routines, and how the medicine affects their hair growth and overall well-being. This will help doctors and patients understand what to expect when using Ritlecitinib in their daily treatment.

At a glance

Status

Recruiting

Sponsor

Pfizer

Enrolment target

850

Start

07 Aug 2024

Estimated completion

31 Mar 2028

Alopecia Areata

What is this study about?

You might have heard about alopecia areata, a condition where your immune system mistakenly attacks your hair follicles, leading to hair loss. This can appear as a few bald patches, or sometimes as complete hair loss on the scalp (alopecia totalis) or even the entire body (alopecia universalis). It can affect anyone, regardless of age, background, or gender.

A new medicine called Ritlecitinib has recently been approved in the UK and other countries for severe alopecia areata in teenagers and adults aged 12 and over. It works by targeting specific pathways in the body that are involved in the immune system's attack on hair follicles. While previous studies have shown good results, those were done in very controlled settings.

This current study aims to see how Ritlecitinib performs in the real world. It will follow patients who are prescribed Ritlecitinib as part of their regular care. The researchers want to understand who uses the medicine, how it's used in daily practice, and most importantly, how patients respond to it and how it affects their daily lives. This information is vital for doctors and patients to make informed decisions about treatment.

Key takeaways

This study looks at Ritlecitinib for alopecia areata in real-world settings.
It aims to understand who uses the medicine and how it works for them.
You must be at least 12 years old and already prescribed Ritlecitinib.
Participation involves your usual clinic visits and completing questionnaires.
Your medical care will not change if you join or decide not to.
Your involvement helps improve future care for people with alopecia areata.

Who may be eligible?

To be part of this study, you need to be at least 12 years old. You must have alopecia areata, and your doctor (a dermatologist) must have confirmed this. Importantly, you should already be prescribed Ritlecitinib by your doctor as part of your usual treatment, not because you’re joining this study.

You also need to be willing to give your permission to be in the study. If you are under 18, your parent or guardian will need to give their permission, and you’ll also need to agree. It's important that you can attend regular check-ups at the clinic and are happy to fill out questionnaires about your health and how you're feeling.

There are some reasons why you might not be able to join. For example, if you have other types of hair loss that aren't alopecia areata, or other skin conditions on your scalp that might make it hard to assess your hair. You also can't have taken Ritlecitinib or similar new medicines before. Lastly, if you or your family work directly on these studies, you won't be able to participate.

Quick self-check

Are you 12 years old or older?
Has a skin doctor (dermatologist) confirmed you have alopecia areata?
Are you currently prescribed Ritlecitinib by your doctor?
Are you able to attend regular clinic visits?
Are you willing to complete questionnaires about your health?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will continue to receive Ritlecitinib as prescribed by your doctor for your alopecia areata. Your doctor will make decisions about your treatment based on what they think is best for you, just like they would for any other patient. The study will involve attending regular check-ups at the clinic, as part of your standard care. During these visits, the study team will gather information about your health and how the treatment is working. You will also be asked to complete questionnaires about your experience and how you are feeling. The exact number and timing of visits will depend on your hospital's usual practice for managing your condition.

Potential risks and benefits

Potential benefits of participating include helping doctors understand how Ritlecitinib works for a wider range of patients in everyday life, which can improve care for others with alopecia areata in the future. As you would already be taking Ritlecitinib as part of your usual care, there are no additional medical risks from the medicine itself due to being in the study. However, some people might find the regular visits or questionnaires a little time-consuming. You are free to withdraw from the study at any time without affecting your medical care.

Locations (58)

C2 Research Center
Montgomery, United States· Recruiting
CENTER FOR DERMATOLOGY CLINICAL RESEARCH, Inc
Fremont, United States· Recruiting
Rao Dermatology
Fresno, United States· Recruiting
Cura Clinical Research
Oxnard, United States· Recruiting
Stanford
Redwood City, United States· Not yet recruiting
Southern California Clinical Research
Santa Ana, United States· Recruiting
Dermatology of Boca
Boca Raton, United States· Recruiting
Pediatric Skin Research,LLC
Coral Gables, United States· Recruiting
Suncoast Skin Solutions
Jacksonville, United States· Recruiting
University of Miami
Miami, United States· Recruiting
Skin Research of South Florida LLC
Miami, United States· Recruiting
Kindred Hair and Skin Center
Marriottsville, United States· Recruiting

+46 more sites — see the official record for the full list.

Common questions

What is alopecia areata?

It's a condition where your immune system attacks your hair follicles, causing hair loss, usually in patches on the scalp, but sometimes elsewhere on the body.

What is Ritlecitinib?

It's a new medicine approved for severe alopecia areata in adults and teenagers aged 12 and over.

Why is this study happening?

To see how Ritlecitinib works for people with alopecia areata in real-life situations, outside of a controlled clinical trial.

Do I have to take Ritlecitinib to be in the study?

Yes, you must already be prescribed Ritlecitinib by your dermatologist as part of your regular treatment.

Will my treatment change if I join the study?

No, your doctor will continue to manage your Ritlecitinib treatment as usual, independently of your participation in this study.

How to find out more

Pfizer CT.gov Call Center

ClinicalTrials.gov_Inquiries@pfizer.com 1-800-718-1021 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.