MedDataX Logo

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

NCT ID: NCT01828086

Last Updated: 2020-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Plaque-type Psoriasis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Psoriasis, chronic plaque-type psoriasis, IL17, monoclonal antibody

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CJM112

CJM112 in different doses; single ascending and multiple ascending

Group Type EXPERIMENTAL

CJM112

Intervention Type BIOLOGICAL

Monoclonal antibody

Placebo

Placebo to match

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Liquid for subcutaneous injection without active drug.

Secukinumab

Active investigational drug.

Group Type ACTIVE_COMPARATOR

Secukinumab

Intervention Type BIOLOGICAL

Monoclonal antibody

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CJM112

Monoclonal antibody

Intervention Type BIOLOGICAL

Secukinumab

Monoclonal antibody

Intervention Type BIOLOGICAL

Placebo

Liquid for subcutaneous injection without active drug.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

AIN475

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novartis Investigative Site

Anniston, Alabama, United States

Site Status

Novartis Investigative Site

Anaheim, California, United States

Site Status

Novartis Investigative Site

Encino, California, United States

Site Status

Novartis Investigative Site

North Hollywood, California, United States

Site Status

Novartis Investigative Site

Miami, Florida, United States

Site Status

Novartis Investigative Site

Miami, Florida, United States

Site Status

Novartis Investigative Site

Orlando, Florida, United States

Site Status

Novartis Investigative Site

Tampa, Florida, United States

Site Status

Novartis Investigative Site

Normal, Illinois, United States

Site Status

Novartis Investigative Site

Indianapolis, Indiana, United States

Site Status

Novartis Investigative Site

Overland Park, Kansas, United States

Site Status

Novartis Investigative Site

Crowley, Louisiana, United States

Site Status

Novartis Investigative Site

Raleigh, North Carolina, United States

Site Status

Novartis Investigative Site

Cincinnati, Ohio, United States

Site Status

Novartis Investigative Site

Oklahoma City, Oklahoma, United States

Site Status

Novartis Investigative Site

Philadelphia, Pennsylvania, United States

Site Status

Novartis Investigative Site

Austin, Texas, United States

Site Status

Novartis Investigative Site

San Antonio, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany Poland Romania United States

Related Links

Access external resources that provide additional context or updates about the study.

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=15349

Results for CCJM112X2101 from the Novartis Trial Results database

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=36

A Plain Language Trial Summary is available on novartisclinicaltrials.com

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CCJM112X2101

Identifier Type: -

Identifier Source: org_study_id