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Completed

NCT Number: NCT01828086

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

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.

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Key information

Conditions

Chronic Plaque-type Psoriasis Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Anniston, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men or women 18-65 years of age at time of consent
  • Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization
  • At randomization, moderate to severe psoriasis as defined by:
  • PASI score of 12 or greater and,
  • IGA score of 3 or greater and,
  • Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.
  • Female patients may be included according to the following:

Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, using highly effective methods of contraception during dosing and for 5 times the terminal half-life of study treatment.

  • Male subjects must agree to comply with two highly effective contraceptive methods

Exclusion criteria

  • Forms of psoriasis other than chronic plaque-type (incl. drug induced psoriasis)
  • Ongoing use of prohibited psoriasis treatments and other prohibited medication at randomization. Washout periods detailed in the protocol have to be adhered to
  • Previous treatment with IL-17 or IL17R blocking agents, including secukinumab
  • Any live vaccines (including nasal-spray flu vaccine) starting from 6 weeks before screening, during the study, and up to 24 weeks after the last dose of CJM112 or secukinumab
  • Evidence of active tuberculosis at screening
  • Active systemic infections (other than common cold)
  • Pregnant or nursing (lactating) women

Treatment and study plan

CJM112

Biological

Monoclonal antibody

Secukinumab

Biological

Monoclonal antibody

Other names: AIN475

Placebo

Other

Liquid for subcutaneous injection without active drug.

Primary outcomes

  1. Number of participants with adverse events as a measure of safety

    Time frame: 19 weeks

    Safety as assessed by the number of participants with adverse events as measured by laboratory parameters, vital signs, electrocardiogram and the collection of serious and non-serious adverse events.

Secondary outcomes

  1. Psoriasis Area and Severity Index (PASI)

    Time frame: 19 weeks

  2. Total CJM112 Concentrations in Serum

    Time frame: 19 weeks

    Measurement of drug levels in the blood of treated patients.

  3. Concentration of anti-CJM112 Antibodies in Serum

    Time frame: 19 weeks

    Assessment of the ability of the compound to evoke an immune response. Assessed in blood of treated patients.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 10, 2013
Registry last updated
Dec 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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