A Dose Ranging Placebo-Controlled Double-Blind Study to Evaluate the Safety and Efficacy of Tezepelumab in Atopic Dermatitis
Summary
This phase 2b study is designed to evaluate the safety and efficacy of tezepelumab as a monotherapy and explore its efficacy as adjunct therapy in subjects with moderate-to-severe atopic dermatitis (AD).
Timeline
- Start
- 2019-03-15
- Primary completion
- 2020-05-12
- Completion
- 2020-12-22
Outcome
Missed primary endpoint
Stopped: “Tezepelumab as a monotherapy in atopic dermatitis did not reach the targeted efficacy level pre-established for this patient population.”
registry analysis (superiority test); Part A: Placebo vs Part A: Tezepelumab 210 mg Q4W; p = 0.56; Odds Ratio (OR) 1.686 (95% CI 0.290 to 9.809); Regression, Logistic; note: Nominal p-value NCT03809663 ↗
registry analysis (superiority test); Part A: Placebo vs Part A: Tezepelumab 280 mg Q2W; p = 0.99; Odds Ratio (OR) 1.011 (95% CI 0.135 to 7.551); Regression, Logistic; note: Nominal p-value NCT03809663 ↗
registry analysis (superiority test); Part A: Placebo vs Part A: Tezepelumab 420 mg Q2W; p = 0.38; Odds Ratio (OR) 2.146 (95% CI 0.390 to 11.800); Regression, Logistic; note: Nominal p-value NCT03809663 ↗
registry analysis (superiority test); Part A: Placebo vs Part A: Tezepelumab 210 mg Q4W; p = 0.97; Odds Ratio (OR) 0.982 (95% CI 0.344 to 2.803); Regression, Logistic; note: Nominal p-value NCT03809663 ↗
registry analysis (superiority test); Part A: Placebo vs Part A: Tezepelumab 280 mg Q2W; p = 0.70; Odds Ratio (OR) 1.217 (95% CI 0.441 to 3.356); Regression, Logistic; note: Nominal p-value NCT03809663 ↗
registry analysis (superiority test); Part A: Placebo vs Part A: Tezepelumab 420 mg Q2W; p = 0.58; Odds Ratio (OR) 0.730 (95% CI 0.243 to 2.197); Regression, Logistic; note: Nominal p-value NCT03809663 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tezepelumab | Monoclonal antibody | 210 mg | Subcutaneous |
| Subject | Tezepelumab | Monoclonal antibody | 280 mg | Subcutaneous |
| Subject | Tezepelumab | Monoclonal antibody | 420 mg | Subcutaneous |