NCT01261767|TerminatedPhase 1

Study Stopped

Trial discontinued due to apparent lack of response in psoriasis measures. No safety concerns were present

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

A Randomised, Double-blind, Placebo-controlled, Single and Multiple Dose, Dose-escalation Trial of Anti-IL-20 (109-0012) 100 mg/Vial in Psoriatic Subjects, Followed by an Expansion Phase

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

NN8226-1848U1111-1118-2792

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredDec 2010

StartedApr 2008

CompletionJan 2011

Brief Summary

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1

Timeline

Completed

Started Apr 2008

Typical duration for phase_1

Geographic Reach

1 country

16 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.8 years study duration

Study Start

First participant enrolled

April 1, 2008

Completed

2.7 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2010

Completed

2 days until next milestone

First Posted

Study publicly available on registry

December 16, 2010

Completed

16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed

Last Updated

February 9, 2017

Status Verified

February 1, 2017

Enrollment Period

2.8 years

First QC Date

December 14, 2010

Last Update Submit

February 8, 2017

Conditions

Inflammation Psoriasis

Outcome Measures

Primary Outcomes (3)

Observed toxicity using the US National Cancer Institute's common terminology criteria for adverse events (CTCAE) - SD phase
from week 0 until end of trial observation period at week 16
Observed toxicity using the US National Cancer Institute's common terminology criteria for adverse events (CTCAE) - MD and MD expansion phases
from week 0 until end of trial observation period at week 22
Improvement psoriasis area and severity index score by 75% (PASI75) - MD expansion phase
at weeks 1-7, 9-15, 22

Secondary Outcomes (6)

Observed toxicity using the US National Cancer Institute's common terminology criteria for adverse events (CTCAE) - MD expansion phase
from week 0 until end of trial observation period at week 22
Improvement psoriasis area and severity index score by 75% (PASI75) - SD and MD phases
SD: at weeks 1, 3, 9, 13 and 16. MD: at weeks 1, 3, 5, 7, 9, 15, 22
Pharmacokinetics (the rate at which the body eliminates the trial drug) - SD and MD phases
SD: Prior to dosing (week 1) and through 24 hours and at each visit (week 1-3, 5, 9, 13 and 16). MD: Prior to dosing and at each dosing visit (week 1, 3, 5, 7)
Pharmacokinetics (the rate at which the body eliminates the trial drug) - MD expansion phase
prior to dosing (week 1) and at each dosing visit (week 2-7)
Pharmacodynamics (the effect of the investigated drug on the body) - SD and MD phases
SD: Prior to dosing (week 1) and through 24 hours and at each visit (week 1-3, 5, 9, 13 and 16). MD: Prior to dosing and at each dosing visit (week 1, 3, 5, 7)
+1 more secondary outcomes

Study Arms (2)

Anti-IL-20

EXPERIMENTAL

Drug: anti-IL-20

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

anti-IL-20DRUG

Anti-IL-20 in 100mg/vial for subcutaneous (under the skin) injection

Anti-IL-20

placeboDRUG

Placebo for subcutaneous (under the skin) injection

Placebo

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.