Study ID: CA43-M23-716 for Alopecia Areata
Summary
This study is testing an investigational drug called BMS-986322 (the “study drug”) in adults with plaque psoriasis. The purpose of the study is to learn whether the study drug is safe and effective at different dose levels.
Study design
If you qualify and choose to participate in this study, you will:
– Take either the study drug (at one of three dose levels) or placebo* for 12 weeks
– Visit the study doctor 8 times for tests and procedures to assess your health and
your plaque psoriasis.
A computer will assign you at random (by chance) to a study group. You will have a 3 in 4 (75%) chance of being in a group that takes the study drug; you will have a 1 in 4 (25%) chance of being in the group that takes only placebo. You will not know which group you are in; the study doctor and staff also will not know.
Study periods
The study is split into three main stages (also known as “study periods”). These are briefly described here. The study doctor will explain them in more detail.
1. Screening (informed consent** followed by screening tests and procedures to find out if you qualify to participate in the study)
2. Study treatment (12 weeks of taking either the study drug or placebo)
3. Follow-up (final visit 30 days after study treatment ends)
* A placebo is a substance that looks like the study drug but contains no active
ingredients. Placebos help us make sure that any changes are due to the study drug and not another reason.
** During informed consent, the study will be explained to you. You will be able to ask any questions you may have about the study.
If you want to take part in the study, you will sign the informed consent form before any screening tests begin.
Study Details
| Study Name | Age Requirements | Length of Study | Type of Treatment |
|---|---|---|---|
|
CA43-M23-716 |
12-63 |
160 Weeks.
(17 visits to the clinic) |
Oral |
Losing Hair Doesn’t Mean Losing Hope
Alopecia areata is a real medical condition that deserves real answers.
So even when losing our
hair feels like losing everything, we can’t lose our hope for a better future.
A potential treatment
option is being explored right now through clinical research, and your participation may make a difference.
You may be able to participate in the study if you:
● Are between 12 and 63 years old
● Have severe patchy hair loss from alopecia areata
● Have not been diagnosed with other types of hair loss (including male or female pattern baldness)
If you are interested in participating, the research study doctor or staff will review additional study criteria with you.
Qualified participants will receive all research study–related drugs (the active investigational
drug or placebo) and research study–related care at no cost. Participants may be reimbursed for research study–related travel and expenses.
About the study
The study is a clinical research study designed to evaluate the safety and efficacy of an
investigational drug compared to a placebo in achieving hair regrowth and improving the quality of life for participants living with alopecia areata. Participants receive either the investigational drug or a placebo (something that looks like the investigational drug but has no effect on the
body), both administered orally (by mouth).
This research study will last up to 160 weeks (about 3 years).
Participants will be assigned
randomly to receive either the investigational drug or a placebo.
After the first 24 weeks (about 6 months) of this study treatment period, some participants will continue to receive their assigned study drug (investigational or placebo) for another 28 weeks (about 7 months) while some
participants receiving the placebo will be randomly assigned to receive the investigational drug.
After the end of this second period, some participants will continue to receive their treatment, and some participants receiving the investigational drug will be given a different dosage of the
investigational drug for the next 108 weeks (about 2 years) of the study.
Contact us about joining the trial
Fill out this form to get in touch. We will contact you in 1-2 business days regarding your application to participate in the trial.