Multiple Ascending Dose Trial of MSB0010841 (Anti-IL17A/F Nanobody) in Psoriasis Subjects
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: MSB0010841; MSB0010841; MSB0010841; MSB0010841; Placebo
Intervention description: MSB0010841(Anti- IL-17A/F Nanobody) will be administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.; MSB0010841 will be administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.; MSB0010841 will be administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.; MSB0010841 will be administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.; Placebo matched to MSB0010841 will be administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Psoriasis; MSB0010841; Anti-IL17A/F Nanobody; M1095

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).
    

Eligibility 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