Single and Multiple Dose Escalation Study to Assess the Safety and Tolerability of CJM112 in Psoriasis

Conditions

• Chronic Plaque-type Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• CJM112 — BIOLOGICAL
  Monoclonal antibody
• Secukinumab — BIOLOGICAL
  Monoclonal antibody
• Placebo — OTHER
  Liquid for subcutaneous injection without active drug.

Study Details

A randomized, double-blind, placebo and positive controlled, single and multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of CJM112 in chronic plaque-type psoriasis patients. This trial never made it to the Phase II part of this trial.

Key Dates

Start date

Jun 30, 2013

Status verified

Mar 2019

Primary completion

Oct 31, 2015

Completion

Oct 31, 2015

Study Design

Enrollment

95 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: CJM112
  CJM112 in different doses; single ascending and multiple ascending
• Placebo Comparator: Placebo
  Placebo to match
• Active Comparator: Secukinumab
  Active investigational drug.

Primary Outcome Measure

Number of participants with adverse events as a measure of safety [ Time Frame: 19 weeks ]

Locations (18)

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