According to the National Institutes of Health, alopecia areata is a disorder that can cause hair loss ranging from loss in well-defined patches to total hair loss. The most common pattern is small circular or patchy bald spots, usually on the scalp. Lost hair may grow back, and re-grown hair may fall out again. In some cases, alopecia areata is associated with anxiety and depression.
Alopecia areata is an autoimmune disorder in which hair follicles are mistakenly attacked by the body's immune system. The immune system usually protects against germs and viruses but can sometimes attack the wrong thing. The investigational drug in the THRIVE study modulates the immune system, meaning that it can inhibit the autoimmune process. The expected result of the investigational drug is that by inhibiting the autoimmune process, hair loss can be limited or stopped.
Alopecia areata is a common form of hair loss, affecting about 2% of the general population at some point during their lifetime. While onset can begin at any age, most people who have it experience their first episode of hair loss before the age of 40, and a substantial number of people have their first episode of hair loss by age 20.
If approved, the investigational oral drug could offer a medical treatment for alopecia areata. This is why it is so important that research studies like the THRIVE study are conducted that may help find new or better medications.
Before new medications can be approved for public use, they must be tested in clinical research studies like the THRIVE study.
The purpose of the THRIVE study is to evaluate an investigational oral drug for people with current hair loss due to alopecia areata that has lasted at least 6 months. The investigational medication will be evaluated for effectiveness on regrowth of hair and for safety.
The investigational drug is a tablet that is taken orally twice a day.
This clinical research study is being conducted at approximately 60 clinical study centers throughout the United States and Canada.
People who pre-qualify and wish to participate will be given an appointment for a screening visit. At this screening visit, the study requirements as well as the potential risks of participation will first be explained in detail. People wishing to participate after this explanation will be asked to sign a written consent form before any screening procedures are performed.
Those people who sign the consent form will enter the screening portion of the study. During screening, the study team will verify that those wishing to participate in the study satisfy all applicable requirements. The screening period may last up to 4 weeks.
If qualified, participants will begin the 24-week long treatment part of the study. Participants will be assigned to receive either the investigational drug or a placebo, a tablet that looks like the study drug but has no active ingredients. The assignment to either study drug or placebo is made randomly, and the chances of receiving the placebo is relatively low at 20%, or a 1 out of 5 chance.
Study participants who complete the 24-week treatment period will be given the option to continue in an open-label extension study in which all participants will receive the active investigational oral drug.
The total duration of participation for those not continuing into the open-label study will be approximately 32 weeks.
All medical examinations and assigned study treatments are provided to qualified participants at no cost. Financial compensation may also be provided to cover travel and other expenses related to the clinical research study.
The amount of available compensation will be discussed with you by the staff at the clinical study center.