Psoriasis Clinical Trial

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

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.

View Eligibility Criteria

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

Study is for people with:

Psoriasis

Phase:

Phase 1

Estimated Enrollment:

95

Study ID:

NCT01828086

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 18 Locations for this study

See Locations Near You

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

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 1

Estimated Enrollment:

95

Study ID:

NCT01828086

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider