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

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 1

Conditions: Psoriasis

Treatments: Drug: MSB0010841; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02156466

200574-003

2013-005436-18 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 41 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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41 participants in 5 patient groups, including a placebo group

MSB0010841 30 mg

Experimental group

Treatment:

Drug: MSB0010841

Drug: MSB0010841

Drug: MSB0010841

Drug: MSB0010841

MSB0010841 60 mg

Experimental group

Treatment:

Drug: MSB0010841

Drug: MSB0010841

Drug: MSB0010841

Drug: MSB0010841

MSB0010841 120 mg

Experimental group

Treatment:

Drug: MSB0010841

Drug: MSB0010841

Drug: MSB0010841

Drug: MSB0010841

MSB0010841 240 mg

Experimental group

Treatment:

Drug: MSB0010841

Drug: MSB0010841

Drug: MSB0010841

Drug: MSB0010841

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo