Multiple Ascending Dose Trial of MSB0010841 (Anti-IL17A/F Nanobody) in Psoriasis Subjects

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, Phase 1, randomized, double-blind, placebo-controlled trial in subjects with moderate to severe psoriasis to assess the safety, tolerability, immunogenicity, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of multiple subcutaneous ascending doses of MSB0010841 (Anti-interleukin-17A/F [Anti-IL-17A/F] Nanobody).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany

Criteria

Inclusion Criteria:

• Chronic plaque psoriasis for at least 6 months before screening

• Greater than or equal to (>=) 10% of BSA with plaques

• Psoriasis Area and Severity Index (PASI) >=12

• Static Physician's Global Assessment (sPGA) >=3 (where scores range from 0 [clear of disease] to 5 [severe disease]) at the screening and baseline visits

• Other protocol defined inclusion criteria could apply

Exclusion Criteria:

• Any condition, including protocol-specified laboratory findings and findings in the medical history or in the pre-trial assessments which in the Investigator's opinion constitutes a risk or a contraindication for the subject's participation in the trial or that could interfere with the trial objectives, conduct or evaluation

• Currently having a form of non-plaque psoriasis as specified in the protocol

• Drug induced psoriasis

• Biological treatments as specified in the protocol, within 3 months prior to Day 1

• Systemic immunosuppressants or phototherapy as specified in the protocol, within 1 month prior to Day 1

• Use of anti-coagulant medications and/or antiplatelet medications as defined in the protocol

• Use of aspirin as defined in the protocol

• Topical corticosteroid treatments other than low-strength or lower-mid strength corticosteroids on the face, scalp, axillae, and/or groin within 1 month prior to Day 1

• Any previous treatment with an agent targeting interleukin (IL)-17, IL-12 and/or IL-23 as specified in the protocol

• Other protocol defined exclusion criteria could apply