Complete Announced during: Premarket · announced Mon 7:00a ET (premarket); before = Fri close; first trade Mon 7:04a ET; time = SEC 8-K acceptance
Insmed (Nasdaq: INSM) reported topline results from a Phase 3 trial of ARIKAYCE in MAC lung disease on March 23, 2026. The company said the trial met its primary endpoint (p=0.0299). ClinicalTrials.gov lists 425 enrolled participants (NCT04677569).
Trial details
- Drug
- ARIKAYCEType Drug Route oral
- Treats
- Studied as a treatment for mycobacterium Infections, nontuberculous.Condition Mycobacterium Infections, Nontuberculous
- Patients
- 425 patients (actual enrollment)2 arms · 258 sites in 23 countries
- Phase
- Phase 3
- Design
- Randomized, double-blind, placebo-controlled, parallel-group
- Primary endpoint
- Change from Baseline in Respiratory Symptom Score at Month 13 (Baseline to Month 13)
- Key secondary endpoints
- Percentage of Participants Achieving Durable Culture Conversion at Month 15
- Change from Baseline in Fatigue Symptom Score at Month 13
- Percentage of Participants Achieving Culture Conversion by Month 6
- Result
- Met endpointTopline efficacy results from the ENCORE study are as follows: ARIKAYCE 590 mg plus azithromycin 250 mg + ethambutol 15 mg/kg (N=213) Placebo plus azithromycin 250 mg + ethambutol 15 mg/kg (N=212) Treatment difference, p-value Primary Endpoint Change from Baseline in Respiratory Symptom Score at Month 13 17.77 points 14.66 points 3.11 points, p=0.0299* Multiplicity-Controlled Secondary…p-value p=0.0299Figures as reported by the sponsor or registry; not calculated by DrugTrials.org.
- Safety
- “The improvements in Respiratory Symptom Score alongside durable culture conversion highlight the potential for this medicine to make a substantial difference in outcomes for patients facing this serious and often progressive infection.” The safety profile was consistent with the known safety…
- Sponsor
- Insmed Nasdaq: INSM
- Dates
- Study start Apr 1, 2021Primary completion Nov 21, 2025Announced Mar 23, 2026, 7:00 AM ET (SEC 8-K filing time)
- Trial ID
- NCT04677569 ClinicalTrials.gov
About this trial
This randomized, double-blind, placebo-controlled, parallel-group Phase 3 trial (NCT04677569) tested ARIKAYCE in Mycobacterium Infections, Nontuberculous. Studied as a treatment for mycobacterium Infections, nontuberculous. It enrolled 425 patients across 2 arms at 258 sites in 23 countries. The primary endpoint was Change from Baseline in Respiratory Symptom Score at Month 13 (Baseline to Month 13). Insmed reported that the trial met its primary endpoint (p-value: p=0.0299). The study started on Apr 1, 2021 and reached primary completion on Nov 21, 2025.
Sources
- Source: SEC EDGAR 8-K (EX-99.1)
- ClinicalTrials.gov record: NCT04677569
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