Phase 2b Study to Evaluate the Efficacy and Safety of ISB 830 in Adults With Moderate to Severe Atopic Dermatitis
Summary
Phase 2b, randomized, double-blinded, placebo-controlled dose range finding study to evaluate the efficacy, safety and tolerability of ISB 830 in adults with moderate to severe atopic dermatitis. The study will be conducted in 2 Parts, with dosing Groups 1-4 comprising Part 1, and dosing Groups 5-6 comprising Part 2. All subjects will receive open-label ISB 830 after a 16 week blinded treatment period.
Timeline
- Start
- 2018-05-31
- Primary completion
- 2020-08-11
- Completion
- 2021-08-03
Outcome
Met primary endpoint
registry analysis (superiority test); ISB 830 600 mg q2w vs Placebo - 2; p = 0.008; LS Mean Difference -17.199 (95% CI -29.895 to -4.503); Mixed Models Analysis NCT03568162 ↗
release “ISB 830 Telazorlimab OX40 Antagonist Antibody Atopic Dermatitis Phase 2b Achieved the primary endpoint” iginnovate.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TELAZORLIMAB | Monoclonal antibody | — | Subcutaneous |