First Human Dose Study of Anti-IL-20 in Psoriasis: A Study of Safety, Tolerability and Early Signals of Biologic and Clinical Effects

Novo Nordisk

Status and phase: Terminated; Phase 1

Conditions: Psoriasis; Inflammation

Treatments: Drug: anti-IL-20; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01261767

U1111-1118-2792 (Other Identifier)

NN8226-1848

Details and patient eligibility

About

This trial is conducted in the United States of America (USA). The aim of this clinical trial is evaluate the safety and tolerability of anti-IL-20 in patients with psoriasis and to determine the preliminary efficacy in an expansion phase of this trial.

This trial consists of 3 parts: A single dose (SD) dose-escalation phase for 16 weeks, a multiple dose (MD) dose-escalation phase for 22 weeks, and a MD expansion phase for 22 weeks.

Initiation of the MD expansion phase will depend on results from the SD and MD dose-escalation phases and only if an acceptable safety profile is present. Subjects participating in the expansion phase are not allowed to have participated in the previous phases (SD and MD dose-escalation phases) of the trial.

Enrollment: 55 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with moderate to severe stable chronic plaque psoriasis for at least 6 months, with or without psoriatic arthritis
• Affected body surface area (BSA) greater than or equal to 15%
• Physician's Global Assessment (PGA) score of 3 or more
• Female subjects of non-childbearing potential or postmenopausal for at least 1 year. Male subjects must agree to use effective method of birth control
• Body Mass Index (BMI) less than or equal to 38.0 kg/m2

Exclusion criteria

• Concomitant anti-psoriatic treatment
• Infectious disease requiring systemic anti-infectious treatment within the 2 weeks prior to administration of trial drug
• Known history of Human Immunodeficiency Virus (HIV)
• Hepatitis B and/or C (determined by test)
• Live virus or bacteria vaccines within the last month before drug administration
• Known active herpes/herpes zoster/cold sores
• Kidney insufficiency
• Liver insufficiency
• Lymphoproliferative disease
• History or signs of malignancy within the last 5 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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55 participants in 2 patient groups, including a placebo group

Anti-IL-20

Experimental group

Treatment:

Drug: anti-IL-20

Placebo

Placebo Comparator group

Treatment:

Drug: placebo