CANAAF is thrilled to share that Concert Pharmaceuticals has announced the launching of THRIVE-AA2, the second planned Phase 3 clinical trial to evaluate the efficacy and safety of CTP-543, an oral Janus kinase (JAK) inhibitor, in adult patients with moderate to severe alopecia areata. Concert expects to report the preliminary results of THRIVE-AA2 in the late half of 2022. Furthermore, Concert believes that the positive results from THRIVE-AA1 and THRIVE-AA2 phase 3 trials could be used as the basis for submitting a New Drug Application to the U.S. Food and Drug Administration (FDA) in early 2023 for CTP-543, for the treatment of moderate to severe alopecia areata in adult patients. This is incredibly exciting as there are currently no treatment options FDA or Health Canada approved for the treatment of alopecia areata in adults or youth.
What is THRIVE-AA2?
THRIVE-AA2 is a randomized, double-blind, placebo-controlled clinical trial in the U.S., Canada, and Europe, for adult patients with moderate to severe alopecia areata. This trial is evaluating the regrowth of scalp hair after 24 weeks of either CTP-543 or a placebo. Hair growth is assessed using the Severity of Alopecia Tool (SALT). As you may remember from our clinical trials presentation this past February (2021), a randomized, double-blind clinical trial is one where neither the researchers nor patients know which treatment they are receiving (CTP 543 or a placebo). This blinding is done to prevent bias in the selection of patients and analysis of results. The FDA has granted CTP-543 Breakthrough Therapy designation for the treatment of adult patients with moderate to severe alopecia areata and Fast Track designation for the treatment of alopecia areata.
More about CTP-543
CTP-543 is an oral selective inhibitor of Janus kinases JAK1 and JAK2, more commonly known as a JAK inhibitor. Our immune system cells communicate with each other using chemical messengers known as cytokines. Among the many cytokines produced by our body, are Janus kinases (JAKs) and signal transducer and activator of transcription (STAT). JAK and STAT proteins are involved in the immune pathways that lead to inflammation, and when they are dysregulated, contribute to autoimmunity. JAK inhibitors work by blocking the signalling between JAK and STAT proteins, which prevents the autoimmune pathway from functioning. Though the JAK/STAT pathway is not the only one involved in the mechanism of alopecia areata, studies have shown that inhibiting it can lead to significant hair growth in many patients.
We are very excited to hear about THRIVE-AA2 and will keep Canadians up to date on breaking research news as it becomes available!
For questions about alopecia areata research, feel free to contact Anthony Gilding, Director of Science & Research Communication for CANAAF at science@canaaf.org
For all other inquiries contact CANAAF at info@canaaf.org.
