A Parallel-design Phase 1 Study to Assess Safety, Tolerability and Pharmacokinetics/Exposure Following Different Single Dose Levels of MOR106 (Administered Subcutaneously or Intravenously) in Healthy Male Subjects (Randomized, Open-label), and in Subjects With Moderate to Severe Atopic Dermatitis (Randomized, Placebo-controlled, Double-blind, Repeated Subcutaneous Dosing Over 12 Weeks)
Phase of Trial: Phase I
Latest Information Update: 19 Nov 2019
Price : $35 *
At a glance
- Drugs MOR 106 (Primary) ; MOR 106 (Primary)
- Indications Atopic dermatitis
- Focus Adverse reactions; Pharmacokinetics
- Sponsors Galapagos NV
- 14 Nov 2019 Planned End Date changed from 1 Dec 2020 to 1 Mar 2020.
- 14 Nov 2019 Planned primary completion date changed from 1 Dec 2020 to 1 Mar 2020.
- 28 Oct 2019 Status changed from recruiting to discontinued. The decision is based on the interim analysis performed on IGUANA trial (NCT03568071) which detected a low probability to meet the primary endpoint of the study (EASI score). The decision was based on a lack of efficacy and not on safety concerns.endpoint of the study (EASI score). The decision was based on a lack of efficacy and not on safety concerns.