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

Chronic Plaque-type Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01828086
• Other study ID #: CCJM112X2101
• Status: Completed
• Phase: Phase 1
• Start date: June 2013
• Est. completion date: October 2015

Study information

• Verified date: March 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Plaque-type Psoriasis
• Psoriasis

Intervention

Biological:
• CJM112
Monoclonal antibody
• Secukinumab
Monoclonal antibody

Other:
• Placebo
Liquid for subcutaneous injection without active drug.

Locations

Country	Name	City	State
United States	Novartis Investigative Site	Anaheim	California
United States	Novartis Investigative Site	Anniston	Alabama
United States	Novartis Investigative Site	Austin	Texas
United States	Novartis Investigative Site	Cincinnati	Ohio
United States	Novartis Investigative Site	Crowley	Louisiana
United States	Novartis Investigative Site	Encino	California
United States	Novartis Investigative Site	Indianapolis	Indiana
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	Normal	Illinois
United States	Novartis Investigative Site	North Hollywood	California
United States	Novartis Investigative Site	Oklahoma City	Oklahoma
United States	Novartis Investigative Site	Orlando	Florida
United States	Novartis Investigative Site	Overland Park	Kansas
United States	Novartis Investigative Site	Philadelphia	Pennsylvania
United States	Novartis Investigative Site	Raleigh	North Carolina
United States	Novartis Investigative Site	San Antonio	Texas
United States	Novartis Investigative Site	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	19 weeks
Secondary	Psoriasis Area and Severity Index (PASI)		19 weeks
Secondary	Total CJM112 Concentrations in Serum	Measurement of drug levels in the blood of treated patients.	19 weeks
Secondary	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.	19 weeks

External Links

•   A Plain Language Trial Summary is available on novartisclinicaltrials.com
•   Results for CCJM112X2101 from the Novartis Trial Results database