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

Primary Purpose

Chronic Plaque-type Psoriasis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CJM112
Secukinumab
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Plaque-type Psoriasis focused on measuring Psoriasis, chronic plaque-type psoriasis, IL17, monoclonal antibody

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

CJM112

Placebo

Secukinumab

Arm Description

CJM112 in different doses; single ascending and multiple ascending

Placebo to match

Active investigational drug.

Outcomes

Primary Outcome Measures

Number of participants with adverse events as a measure of safety
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

Psoriasis Area and Severity Index (PASI)
Total CJM112 Concentrations in Serum
Measurement of drug levels in the blood of treated patients.
Concentration of anti-CJM112 Antibodies in Serum
Assessment of the ability of the compound to evoke an immune response. Assessed in blood of treated patients.

Full Information

First Posted
April 5, 2013
Last Updated
December 9, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01828086
Brief Title
Single and Multiple Dose Escalation Study to Assess the Safety and Tolerability of CJM112 in Psoriasis
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 Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Plaque-type Psoriasis
Keywords
Psoriasis, chronic plaque-type psoriasis, IL17, monoclonal antibody

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CJM112
Arm Type
Experimental
Arm Description
CJM112 in different doses; single ascending and multiple ascending
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo to match
Arm Title
Secukinumab
Arm Type
Active Comparator
Arm Description
Active investigational drug.
Intervention Type
Biological
Intervention Name(s)
CJM112
Intervention Description
Monoclonal antibody
Intervention Type
Biological
Intervention Name(s)
Secukinumab
Other Intervention Name(s)
AIN475
Intervention Description
Monoclonal antibody
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Liquid for subcutaneous injection without active drug.
Primary Outcome Measure Information:
Title
Number of participants with adverse events as a measure of safety
Description
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.
Time Frame
19 weeks
Secondary Outcome Measure Information:
Title
Psoriasis Area and Severity Index (PASI)
Time Frame
19 weeks
Title
Total CJM112 Concentrations in Serum
Description
Measurement of drug levels in the blood of treated patients.
Time Frame
19 weeks
Title
Concentration of anti-CJM112 Antibodies in Serum
Description
Assessment of the ability of the compound to evoke an immune response. Assessed in blood of treated patients.
Time Frame
19 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Novartis Investigative Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Novartis Investigative Site
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Novartis Investigative Site
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Novartis Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Novartis Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Novartis Investigative Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
Novartis Investigative Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Novartis Investigative Site
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Novartis Investigative Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Novartis Investigative Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Novartis Investigative Site
City
Crowley
State/Province
Louisiana
ZIP/Postal Code
70526
Country
United States
Facility Name
Novartis Investigative Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Novartis Investigative Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45255
Country
United States
Facility Name
Novartis Investigative Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Novartis Investigative Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Novartis Investigative Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Novartis Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=15349
Description
Results for CCJM112X2101 from the Novartis Trial Results database
URL
https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=36
Description
A Plain Language Trial Summary is available on novartisclinicaltrials.com

Learn more about this trial

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

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