Insmed Incorporated reported Phase 2b CEDAR study of brensocatib in hidradenitis suppurativa missed primary and secondary endpoints; program discontinued despite favorable safety.
Written By: Sana Khan, BPharm
Reviewed By: Pharmacally Editorial Team
Insmed Incorporated announced that the Phase 2b CEDAR study evaluating brensocatib in adults with moderate to severe hidradenitis suppurativa (HS) did not meet its primary or secondary efficacy endpoints at either the 10 mg or 40 mg doses. The company stated that brensocatib was generally well tolerated, with no new safety signals observed, including at the 40 mg dose, the highest tested to date. Following these results, Insmed will discontinue development of brensocatib for HS and plans to present detailed findings at a future scientific congress.
Efficacy Results Show No Benefit Over Placebo
At Week 16, reductions in total abscess and inflammatory nodule (AN) count were lower in both brensocatib groups compared with placebo. Patients receiving brensocatib 10 mg and 40 mg experienced reductions of 45.5% and 40.3%, respectively, while the placebo arm showed a 57.1% reduction from baseline. These findings indicate that brensocatib did not demonstrate clinical benefit in this patient population.
Safety Profile Remains Favorable
Brensocatib was generally well tolerated across both dose groups. Treatment-emergent adverse events (TEAEs) occurred in 55.4% of patients receiving 10 mg, 42.9% receiving 40 mg, and 45.7% in the placebo group. Severe TEAEs were uncommon, reported in one patient (1.4%) in the 10 mg arm and none in the 40 mg or placebo arms. Serious TEAEs occurred in 4.1% of patients in the 10 mg arm and 1.4% in both the 40 mg and placebo groups.
Company Perspective on Study Outcome
Insmed’s Chief Medical Officer Martina Flammer stated that the CEDAR study was designed as a proof-of-concept trial to evaluate whether brensocatib could benefit patients with HS, a disease with limited preclinical models that complicate drug development. She noted that although the results were disappointing, insights from the trial may contribute to broader scientific understanding of HS. The company also acknowledged the contributions of participating patients and investigators.
About the Phase 2b CEDAR Study
CEDAR (NCT06685835) was a randomized, double-blind, placebo-controlled Phase 2b trial evaluating brensocatib in adults with moderate to severe HS. The study enrolled 214 patients across 72 global sites. Participants were randomized 1:1:1 to receive brensocatib 10 mg, brensocatib 40 mg, or placebo once daily for 16 weeks. After the placebo-controlled period, patients either continued their assigned brensocatib dose or switched from placebo to one of the active treatment arms. The primary endpoint was percent change from baseline in total abscess and inflammatory nodule count at Week 16.
Reference
Insmed Provides Clinical Update on Phase 2b CEDAR Study, 07 April 2026, Insmed Provides Clinical Update on Phase 2b CEDAR Study – Apr 7, 2026
A Study of the Efficacy and Safety of Brensocatib in Adults with Moderate to Severe Hidradenitis Suppurativa (HS) (CEDAR), ClinicalTrials.gov ID NCT06685835, https://clinicaltrials.gov/study/NCT0668583
About the Writer
Sana Jamil Khan is a B.Pharm graduate with a strong interest in medical writing and scientific communication. Her work focuses on interpreting clinical research, exploring developments in pharmaceutical science, and presenting complex medical information in a clear and accessible manner. She is particularly interested in topics related to human clinical studies, drug safety observations, and emerging therapeutic research.