Complete Announced during: After hours · announced Tue 4:01p ET (after hours); before = Tue close; first trade Tue 4:02p ET; time = SEC 8-K acceptance
Avalo Therapeutics (Nasdaq: AVTX) reported topline results from a Phase 2 trial of abdakibart in hidradenitis suppurativa on May 5, 2026. The company said the trial met its primary endpoint. ClinicalTrials.gov lists 253 enrolled participants (NCT06603077).
Trial details
- Drug
- AbdakibartType Drug Route subcutaneous
- Treats
- Studied as a treatment for hidradenitis suppurativa.Condition Hidradenitis Suppurativa
- Patients
- 253 patients (actual enrollment)3 arms · 89 sites in 13 countries
- Phase
- Phase 2
- Design
- Randomized, double-blind, placebo-controlled, parallel-group
- Primary endpoint
- Proportion of patients achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) (At Week 16)
- Key secondary endpoints
- Proportion of patients achieving HiSCR50
- Proportion of patients achieving HiSCR90
- Change from Baseline in International HS Severity Score System (IHS4)
- Result
- Met endpointThe LOTUS trial successfully met its primary endpoint at both doses studied.
- Safety
- The physical and emotional burden of HS is profound, and I am encouraged to see an investigational therapy showing such robust and clinically relevant results.” 1 Across the study, abdakibart was well tolerated.
- Sponsor
- Avalo Therapeutics Nasdaq: AVTX
- Dates
- Study start Sep 16, 2024Primary completion Feb 23, 2026Announced May 5, 2026, 4:01 PM ET (SEC 8-K filing time)
- Trial ID
- NCT06603077 ClinicalTrials.gov
About this trial
This randomized, double-blind, placebo-controlled, parallel-group Phase 2 trial (NCT06603077) tested Abdakibart in Hidradenitis Suppurativa. Studied as a treatment for hidradenitis suppurativa. It enrolled 253 patients across 3 arms at 89 sites in 13 countries. The primary endpoint was Proportion of patients achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) (At Week 16). Avalo Therapeutics reported that the trial met its primary endpoint. The study started on Sep 16, 2024 and reached primary completion on Feb 23, 2026.
Sources
- Source: SEC EDGAR 8-K (EX-99.1)
- ClinicalTrials.gov record: NCT06603077
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