A study for adults with severe alopecia areata comparing amlitelimab (subcutaneous injections) to placebo

Study for Severe Alopecia Areata

Recruiting
18 years or above
All
Phase 2
150 participants needed
2 Locations

Study Overview

This study is looking for individuals at least 18 years of age with severe alopecia areata (AA). Alopecia areata is a common hair loss condition that results in patches of hair loss on the scalp, eyebrows, eyelashes or on any other hair-bearing region of the body. Alopecia areata can affect your health, social functioning, psychological well-being and quality of life. 

 

Available medications for AA are not always effective or suitable for all patients. Amlitelimab is an investigational medication that is being developed for treating people with severe AA. It is not yet approved for treating AA and can only be used in a study like this one. 

 

Sanofi believes that everyone should have the opportunity to take part in clinical trials. It is important to include people who have been historically under-represented in clinical trials. Sanofi is committed to inclusivity in our studies. 

 

If you are interested in learning more about this study, we encourage you to complete a brief questionnaire to help determine if you may qualify to participate and be referred to a site recruiting in your area for further evaluation.

  

For more information on alopecia areata, please visit the National Alopecia Areata Foundation (NAAF).

Study Details

This study will include approximately 150 participants in 16 countries. The study will include two treatment periods:

 

  1. All participants will have a 2 out of 3 chance of receiving the investigational medication (or 1 out of 3 chance of receiving the placebo) during the first treatment period.  A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine. This period is about nine (9) months and will include 11 visits to the study center. During this period, you will receive 10 injections just under the skin of your abdomen, thigh or upper arm.  
  2. Optional extension period where all participants will receive the investigational medication. This period is about two (2) years and will include 13 visits to the study center. During this period, you will receive 26 injections just under the skin of your abdomen, thigh or upper arm.  

 

Study assessments include: 

·         Physical exam 

·         Electrocardiogram (ECG) 

·         Blood and urine tests 

·         Clinician and patient reported outcomes (questionnaires) 

 

There is no cost to participate. All study-related exams, study-related medications and study-related medical care is provided. There is no insurance required to take part in this study. You may be compensated for time and travel.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Alopecia Areata
  • Age: 18 Years or older
  • Gender: All
Updated on 03 Dec 2024. Study ID: NCT06444451

This study investigates severe alopecia areata, a condition where individuals experience hair loss in patches on the scalp or other parts of the body. This condition can affect various aspects of life including health and psychological well-being. The purpose of this study is to explore the effects of an investigational medication for people with severe alopecia areata who are 18 years or older.

Participants in this study will undergo various procedures. There will be two treatment periods. In the first period, participants have a chance of receiving either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine. This period lasts about nine months and involves 11 visits to the study center. In the optional extension period, everyone will receive the investigational medication over two years, with 13 visits. Assessments include physical exams, ECGs, blood and urine tests, and questionnaires.

  • Who can participate: Adults aged 18 years or older with severe alopecia areata can participate. All genders are eligible.
  • Study details: Participants will receive injections of the investigational medication. There will be physical exams, ECGs, and other assessments during the study.
  • Study timelines and visits: The study will last about two years and nine months. The study requires 24 visits.

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