Phase 2
Completed N=149
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Hidradenitis Suppurativa
Source: ClinicalTrials.gov NCT04856930 ↗Enrolled (actual)
149
Serious AEs
2.2%
Results posted
Sep 2025
Primary outcomePrimary: Change From Baseline in AN Count at Week 16: Placebo-Controlled Period — -5.9; -4.1; -5.6 count of abscess and inflammatory nodule — p=0.7841
Summary
Efficacy and safety of imsidolimab (ANB019) in participants with Hidradenitis Suppurativa
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in AN Count at Week 16: Placebo-Controlled Period |
-5.9; -4.1; -5.6 | 0.7841 |
| SECONDARY Percent Change From Baseline in AN Count at Week 16: Placebo-Controlled Period |
-44.7; -36.7; -41.2 | 0.5939 |
| SECONDARY Number of Participants Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50): Placebo-Controlled Period |
16; 16; 15 | — |
| SECONDARY Change From Baseline in Worst HS Pain NRS Score at Week 16: Placebo-Controlled Period |
-0.3; -0.7; -0.4 | 0.7282 |
| SECONDARY Change From Baseline in Average HS Pain NRS Score at Week 16: Placebo-Controlled Period |
-0.5; -1.0; -0.5 | 0.7698 |
| SECONDARY Percent Change From Baseline in Worst HS Pain NRS Score at Week 16: Placebo-Controlled Period |
7.6; 10.2; 30.3 | 0.2750 |
| SECONDARY Percent Change From Baseline in Average HS Pain NRS Score at Week 16: Placebo-Controlled Period |
-1.3; -18.3; 4.5 | 0.6146 |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs): Placebo-Controlled Period |
19; 14; 18 | — |
| SECONDARY Number of Participants With TEAEs: Extension and Follow-up Period |
15; 18; 9; 10 | — |
Eligibility Criteria
Inclusion Criteria
- Clinically confirmed diagnosis of active HS with a disease duration of greater than or equal to (≥) 6 months before Day 1.
- HS lesions present in at least 2 distinct anatomical areas.
- Total Abscess and inflammatory nodule (AN) count ≥ 5.
- Draining fistulas less than or equal to (≤) 20.
- Stable HS for at least 6 weeks prior to Day 1 visit.
Exclusion Criteria
- Concomitant dermatological or medical conditions that may interfere with the Investigators' ability to evaluate the participant's response to therapy.
Data sourced from ClinicalTrials.gov (NCT04856930). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.