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

Novartis

Status and phase: Completed; Phase 1

Conditions: Chronic Plaque-type Psoriasis

Treatments: Biological: Secukinumab; Other: Placebo; Biological: CJM112

Study type: Interventional

Funder types: Industry

Identifiers

NCT01828086

CCJM112X2101

Details and patient eligibility

About

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.

Enrollment: 95 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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95 participants in 3 patient groups, including a placebo group

CJM112

Experimental group

Description:

CJM112 in different doses; single ascending and multiple ascending

Treatment:

Biological: CJM112

Placebo

Placebo Comparator group

Description:

Placebo to match

Treatment:

Other: Placebo

Secukinumab

Active Comparator group

Description:

Active investigational drug.

Treatment:

Biological: Secukinumab