European Academy of Dermatology and Venereology Congress

European Academy of Dermatology and Venereology Congress

Source:

Cassella J, et al. Initial results from a long-term, open-label extension study with CTP-543, an oral Janus kinase inhibitor, in patients with moderate to severe alopecia areata. Presented at: European Academy of Dermatology and Venereology Congress; Oct 29-31, 2020 (virtual meeting).

Disclosures: Cassella reports he is an employee of Concert Pharmaceuticals, receiving salary and stock.
November 12, 2020
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JAK inhibitor CTP-543 maintains, improves hair regrowth in alopecia areata

Source:

Cassella J, et al. Initial results from a long-term, open-label extension study with CTP-543, an oral Janus kinase inhibitor, in patients with moderate to severe alopecia areata. Presented at: European Academy of Dermatology and Venereology Congress; Oct 29-31, 2020 (virtual meeting).

Disclosures: Cassella reports he is an employee of Concert Pharmaceuticals, receiving salary and stock.
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Good safety and continued stability of hair regrowth were seen with CTP-543, a selective Janus kinase inhibitor, in an open-label extension study of patients with moderate to severe alopecia areata.

“Alopecia areata is a devastating and poorly treated autoimmune disease. ... Worldwide prevalence rate is about 0.2% of the population,” James V. Cassella, PhD, of Concert Pharmaceuticals, said during a presentation at the European Academy of Dermatology and Venereology virtual congress. “It’s a disease that profoundly impacts patients and is associated with anxiety, depression and other autoimmune conditions. There are a few treatment options available for patients with alopecia areata in the U.S. with no FDA-approved treatment option.”

In the open-label extension study to evaluate the long-term safety and efficacy of selective JAK1 and JAK2 inhibitor CTP-543, eligible patients included those who completed 24 weeks of treatment from three qualifying phase 2 trials. Enrolled patients received twice-daily oral treatment of 8 mg CTP-543 or twice-daily oral treatment of 12 mg CTP-543; patients who previously received placebo began active treatment at the 12 mg twice-daily dose.

Researchers assessed patients for adverse events and evaluated drug efficacy using the Severity of Alopecia Tool (SALT) monthly for the first 3 months and bimonthly thereafter. This trial is currently ongoing and is projected to conclude at 108 weeks.

Of 152 patients, approximately 130 patients have received CTP-543 for longer than 1 year. It has been well tolerated, with 76% of adverse events reported as mild, 21% as moderate and 2% as severe.
Compared with previous study data and SALT scores, patients continuing the 12 mg dose had strong stability of hair regrowth, and patients who escalated from the 8 mg dose to the 12 mg dose had an improved response. Two patients lost drug response.

“Hair regrowth assessed by SALT was sustained or improved in the vast majority of patients relative to the phase 2 results. ... The results are very encouraging as we continue to see a good safety and continued stability of the hair regrowth,” Cassella said. “We will continue to recruit patients into this open-label extension coming from the phase 3 [study], which will be starting in the near future.”