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Alopecia areata clinical trial
Take control by taking part
About the ALLEGRO 100 clinical trial
The purpose of this clinical trial is to see if a higher dose (100 mg) per day of ritlecitinib is safe, prevents hair loss, and helps more hair grow back in people with severe alopecia areata.
The medicine being studied is called ritlecitinib and is already approved for the treatment of severe alopecia areata in individuals 12 years or older at a dose of 50 mg per day.
If you qualify and decide to participate in this clinical trial, you will receive the following at no cost:
- Trial-related medical care
- Study medicine
- Monitoring from a team of dedicated alopecia areata specialists
About alopecia areata
Alopecia areata is an autoimmune disorder where the immune system mistakenly attacks hair follicles, leading to hair loss. People with alopecia areata usually lose patches of hair on their scalp but, in some cases, people may lose all of the hair on their head or body.1 This significantly impacts quality of life. Despite advances in alopecia areata treatment, there is still a need for treatments for severe cases in adults.
Who can participate?
It’s important that all people with alopecia areata have treatment options that work for them. Ensuring diversity within clinical trials enables us to see how potential medicines work in different people. We’ll be looking at factors like age, sex, and ethnicity to see if treatment is effective for all people with alopecia areata.
You may be eligible to participate if you*:
- Are 12 years of age or older
- Have been diagnosed with alopecia areata and do not have hair loss caused by any other conditions
- Have lost at least 50% of the hair on your scalp
*There may be additional requirements to participate. The trial team can help determine if you qualify to enroll in the trial.
What to expect
If you qualify and you decide to take part in this clinical trial, you will be randomly assigned (like flipping a coin) to receive either 50 mg or 100 mg of ritlecitinib daily. Neither you nor the trial doctor will know which dose you have been assigned, and if the dose has changed.
If you are initially assigned to receive 50 mg, and your symptoms aren’t improving, you may be reassigned to receive 100 mg after 6 months.
The clinical trial will last about 14 months, and you will have about 9 visits. You will take ritlecitinib once daily for up to 48 weeks. Four weeks after your last dose, you will have a follow-up appointment so the team can check on your health.
Choosing to join a clinical trial is a personal decision. We thank you for considering participation in this trial.
Frequently asked questions
The ALLEGRO 100 clinical trial is looking to see if taking a higher dose (100 mg) per day of ritlecitinib is safe, prevents hair loss, and helps more hair grow back in people with severe alopecia areata.
Other clinical trials of ritlecitinib showed that the 100 mg dose significantly improved hair growth for some participants compared to a placebo.2
A placebo looks like the study medicine, but contains no active medicine.
No. All participants will take either 50 mg or 100 mg of ritlecitinib. Additionally, if you are initially assigned to receive 50 mg and your symptoms aren’t improving, you may be reassigned to receive 100 mg after 6 months. Neither you nor the trial doctor will know which dose you are receiving.
All clinical trials have possible risks. The trial team will explain the known risks and side effects of the study medicine during the informed consent process, before you decide to participate.
Your trial doctor will conduct a physical exam and a series of tests similar to those you may have at a regular doctor’s visit. Your trial doctor will also examine and photograph your scalp, eyelashes, and eyebrows to see how much hair loss you have and how much you have gained.
Participants cannot shave their scalp, eyebrows, or eyelashes during the clinical trial. Participants are allowed to keep their hair short. The trial doctor can tell you the appropriate length so the trial team can properly monitor hair regrowth. Additionally, hair transplants and scalp, eyebrow, and eyelash tattooing or microblading are not allowed during the clinical trial.
Wigs and hair extensions may be used during the trial but must be removed at trial visits for scalp assessments. Hair dye and color is also permitted but is discouraged within 7 days prior to a visit.
Mascara and eyelash extensions are also allowed during the clinical trial, but should be removed before visits. Eyelash extensions applied with adhesive glue are discouraged.
References
1. Oakley A, Bell H. Alopecia areata. DermNet. 1997. Updated May 2022. Accessed March 17, 2025. https://dermnetnz.org/topics/alopecia-areata
2. Results with LITFULO. Litfulo.com. Accessed March 17, 2025. https://www.litfulo.com/get-to-know-litfulo/results-with-litfulo