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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01828086
Recruitment Status : Completed
First Posted : April 10, 2013
Last Update Posted : December 11, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Plaque-type Psoriasis Biological: CJM112 Biological: Secukinumab Other: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : June 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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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 Name: AIN475


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828086


Locations
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United States, Alabama
Novartis Investigative Site
Anniston, Alabama, United States, 36207
United States, California
Novartis Investigative Site
Anaheim, California, United States, 92801
Novartis Investigative Site
Encino, California, United States, 91436
Novartis Investigative Site
North Hollywood, California, United States, 91606
United States, Florida
Novartis Investigative Site
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
United States, Illinois
Novartis Investigative Site
Normal, Illinois, United States, 61761
United States, Indiana
Novartis Investigative Site
Indianapolis, Indiana, United States, 46256
United States, Kansas
Novartis Investigative Site
Overland Park, Kansas, United States, 66211
United States, Louisiana
Novartis Investigative Site
Crowley, Louisiana, United States, 70526
United States, North Carolina
Novartis Investigative Site
Raleigh, North Carolina, United States, 27612
United States, Ohio
Novartis Investigative Site
Cincinnati, Ohio, United States, 45255
United States, Oklahoma
Novartis Investigative Site
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Novartis Investigative Site
Philadelphia, Pennsylvania, United States, 19103
United States, Texas
Novartis Investigative Site
Austin, Texas, United States, 78759
Novartis Investigative Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Additional Information:

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01828086    
Other Study ID Numbers: CCJM112X2101
First Posted: April 10, 2013    Key Record Dates
Last Update Posted: December 11, 2020
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Psoriasis, chronic plaque-type psoriasis, IL17, monoclonal antibody
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases