A Study of Intravenous MK-8226 in Participants With Moderate-to-Severe Atopic Dermatitis (MK-8226-003)
Summary
This is a 3-part study to assess the safety, tolerability, efficacy, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of MK-8226 in participants with moderate to severe atopic dermatitis. Part 1 (multiple rising dose study) objectives were to find the maximum tolerated dose (MTD) of MK-8226 and to assess safety and PK. Part 2 objectives were to determine safety, PK, and preliminary efficacy. Part 3 objectives were to further define safety and PK, and explore MK-8226 PK/PD to model the optimal dose range for future studies. The study was terminated early due to business reasons on 08 May 2014; final results from an analysis for Part 1 (efficacy, PK, safety, immunogenicity) and Part 2 (safety, immunogenicity) are summarized.
Timeline
- Start
- 2012-12-21
- Primary completion
- 2014-10-20
- Completion
- 2014-10-20
Outcome
Met primary endpoint
Stopped (Business): “The study was prematurely stopped due to business reasons.”
registry Part 1: MK-8226 3 mg/kg vs Part 1: Placebo (Pooled); p = 0.015; Mean Difference (Final Values) -9.82 NCT01732510 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Solrikitug | Monoclonal antibody | 0.3 mg/kg | Intravenous |
| Subject | Solrikitug | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Solrikitug | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Solrikitug | Monoclonal antibody | 10 mg/kg | Intravenous |