Evaluation of Sonelokimab for the Treatment of Patients With Active Moderate to Severe Hidradenitis Suppurativa
Summary
This is a study to demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa.
Timeline
- Start
- 2022-04-25
- Primary completion
- 2023-05-09
- Completion
- 2023-08-30
Outcome
Met primary endpoint
release “The MIRA trial met its primary endpoint” moonlaketx.com ↗
release “In June 2023, the MIRA trial met its primary endpoint, the Hidradenitis Suppurativa Clinical Response (HiSCR)75” moonlaketx.com ↗
release “MIRA trial (NCT05322473) at 12 weeks showed that the trial met its primary endpoint” moonlaketx.com ↗
release “In June 2023, topline results of the MIRA trial at 12 weeks showed that the trial met its primary endpoint, HiSCR75.” moonlaketx.com ↗
release “In June 2023, topline results of the MIRA trial (NCT05322473) at 12 weeks showed that the trial met its primary endpoint” moonlaketx.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Adalimumab | Monoclonal antibody | — | — |
| Subject | M1095 | Protein / enzyme biologic | 120 mg | Subcutaneous |
| Subject | M1095 | Protein / enzyme biologic | 240 mg | Subcutaneous |