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

December 9, 2020 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Novartis Investigative Site
    • California
      • Anaheim, California, United States, 92801
        • Novartis Investigative Site
      • Encino, California, United States, 91436
        • Novartis Investigative Site
      • North Hollywood, California, United States, 91606
        • Novartis Investigative Site
    • Florida
      • Miami, Florida, United States, 33136
        • Novartis Investigative Site
      • Miami, Florida, United States, 33175
        • Novartis Investigative Site
      • Orlando, Florida, United States, 32809
        • Novartis Investigative Site
      • Tampa, Florida, United States, 33609
        • Novartis Investigative Site
    • Illinois
      • Normal, Illinois, United States, 61761
        • Novartis Investigative Site
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Novartis Investigative Site
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Novartis Investigative Site
    • Louisiana
      • Crowley, Louisiana, United States, 70526
        • Novartis Investigative Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Novartis Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45255
        • Novartis Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Novartis Investigative Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19103
        • Novartis Investigative Site
    • Texas
      • Austin, Texas, United States, 78759
        • Novartis Investigative Site
      • San Antonio, Texas, United States, 78229
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CJM112
CJM112 in different doses; single ascending and multiple ascending
Biological: CJM112
Monoclonal antibody
PLACEBO_COMPARATOR: Placebo
Placebo to match
Other: Placebo
Liquid for subcutaneous injection without active drug.
ACTIVE_COMPARATOR: Secukinumab
Active investigational drug.
Biological: Secukinumab
Monoclonal antibody
Other Names:
  • AIN475

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
19 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psoriasis Area and Severity Index (PASI)
Time Frame: 19 weeks
19 weeks
Total CJM112 Concentrations in Serum
Time Frame: 19 weeks
Measurement of drug levels in the blood of treated patients.
19 weeks
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.
19 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ACTUAL)

October 1, 2015

Study Completion (ACTUAL)

October 1, 2015

Study Registration Dates

First Submitted

April 5, 2013

First Submitted That Met QC Criteria

April 9, 2013

First Posted (ESTIMATE)

April 10, 2013

Study Record Updates

Last Update Posted (ACTUAL)

December 11, 2020

Last Update Submitted That Met QC Criteria

December 9, 2020

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCJM112X2101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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