Single and Multiple Dose Escalation Study to Assess the Safety and Tolerability of CJM112 in Psoriasis
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
1 other identifier
interventional
95
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2013
Typical duration for phase_1
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2013
CompletedFirst Posted
Study publicly available on registry
April 10, 2013
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedDecember 11, 2020
March 1, 2019
2.3 years
April 5, 2013
December 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Psoriasis Area and Severity Index (PASI)
19 weeks
Total CJM112 Concentrations in Serum
19 weeks
Concentration of anti-CJM112 Antibodies in Serum
19 weeks
Study Arms (3)
CJM112
EXPERIMENTALCJM112 in different doses; single ascending and multiple ascending
Placebo
PLACEBO COMPARATORPlacebo to match
Secukinumab
ACTIVE COMPARATORActive investigational drug.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Novartis Investigative Site
Anniston, Alabama, 36207, United States
Novartis Investigative Site
Anaheim, California, 92801, United States
Novartis Investigative Site
Encino, California, 91436, United States
Novartis Investigative Site
North Hollywood, California, 91606, United States
Novartis Investigative Site
Miami, Florida, 33136, United States
Novartis Investigative Site
Miami, Florida, 33175, United States
Novartis Investigative Site
Orlando, Florida, 32809, United States
Novartis Investigative Site
Tampa, Florida, 33609, United States
Novartis Investigative Site
Normal, Illinois, 61761, United States
Novartis Investigative Site
Indianapolis, Indiana, 46256, United States
Novartis Investigative Site
Overland Park, Kansas, 66211, United States
Novartis Investigative Site
Crowley, Louisiana, 70526, United States
Novartis Investigative Site
Raleigh, North Carolina, 27612, United States
Novartis Investigative Site
Cincinnati, Ohio, 45255, United States
Novartis Investigative Site
Oklahoma City, Oklahoma, 73112, United States
Novartis Investigative Site
Philadelphia, Pennsylvania, 19103, United States
Novartis Investigative Site
Austin, Texas, 78759, United States
Novartis Investigative Site
San Antonio, Texas, 78229, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2013
First Posted
April 10, 2013
Study Start
June 1, 2013
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
December 11, 2020
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share