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. A common pattern is small circular or patchy bald spots, usually on the scalp, but some people have greater amounts of hair loss on the scalp or body. Lost hair may grow back, and re-grown hair may fall out again.
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 clinical trials program is designed to modulate 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 those in the THRIVE clinical trials program, 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 clinical trials program.
The purpose of the research studies in the THRIVE clinical trials program is to evaluate an investigational oral drug for people with current hair loss due to alopecia areata that meets the requirements listed above. The investigational drug 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.
The clinical research studies are being conducted at study centers located in 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.
If qualified, participants will begin the treatment period of the study. As in many research studies, participants will be randomly assigned to receive either the investigational drug or a placebo, a tablet that looks like the study drug but has no active ingredients. Depending on the specific research study in the THRIVE clinical trials program, the chances of initially being assigned placebo is relatively low (less than a 1 out of 4 chance). Upon completion of the treatment period, study participants may have the opportunity to join an open-label extension study in which all participants will receive the investigational drug.
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.