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

Phase 1

Completed

• Conditions: Chronic Plaque-type Psoriasis
• Interventions: Biological: Secukinumab; Other: Placebo; Biological: CJM112

• Registration Number: NCT01828086
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-05
• Study First Submitted QC: 2013-04-09
• Study First Posted: 2013-04-10
• Study Start: 2013-06
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2019-03
• Last Update Submitted: 2020-12-09
• Last Update Posted: 2020-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Secukinumab	Secukinumab	Active investigational drug.
Placebo	Placebo	Placebo to match
CJM112	CJM112	CJM112 in different doses; single ascending and multiple ascending

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events as a measure of safety	19 weeks	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

Name	Time	Method
Psoriasis Area and Severity Index (PASI)	19 weeks
Total CJM112 Concentrations in Serum	19 weeks	Measurement of drug levels in the blood of treated patients.
Concentration of anti-CJM112 Antibodies in Serum	19 weeks	Assessment of the ability of the compound to evoke an immune response. Assessed in blood of treated patients.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇺🇸 San Antonio, Texas, United States