First Human Dose Study of Anti-IL-20 in Psoriasis: A Study of Safety, Tolerability and Early Signals of Biologic and Clinical Effects
This study has been terminated.
(Trial discontinued due to apparent lack of response in psoriasis measures. No safety concerns were present)
Sponsor:
Novo Nordisk
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01261767
First received: December 14, 2010
Last updated: April 15, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Inflammation Psoriasis |
Drug: anti-IL-20 Drug: placebo |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Observed toxicity using the US National Cancer Institute's common terminology criteria for adverse events (CTCAE) - SD phase [ Time Frame: from week 0 until end of trial observation period at week 16 ] [ Designated as safety issue: No ]
- Observed toxicity using the US National Cancer Institute's common terminology criteria for adverse events (CTCAE) - MD and MD expansion phases [ Time Frame: from week 0 until end of trial observation period at week 22 ] [ Designated as safety issue: No ]
- Improvement psoriasis area and severity index score by 75% (PASI75) - MD expansion phase [ Time Frame: at weeks 1-7, 9-15, 22 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Observed toxicity using the US National Cancer Institute's common terminology criteria for adverse events (CTCAE) - MD expansion phase [ Time Frame: from week 0 until end of trial observation period at week 22 ] [ Designated as safety issue: No ]
- Improvement psoriasis area and severity index score by 75% (PASI75) - SD and MD phases [ Time Frame: SD: at weeks 1, 3, 9, 13 and 16. MD: at weeks 1, 3, 5, 7, 9, 15, 22 ] [ Designated as safety issue: No ]
- Pharmacokinetics (the rate at which the body eliminates the trial drug) - SD and MD phases [ Time Frame: 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) ] [ Designated as safety issue: No ]
- Pharmacokinetics (the rate at which the body eliminates the trial drug) - MD expansion phase [ Time Frame: prior to dosing (week 1) and at each dosing visit (week 2-7) ] [ Designated as safety issue: No ]
- Pharmacodynamics (the effect of the investigated drug on the body) - SD and MD phases [ Time Frame: 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) ] [ Designated as safety issue: No ]
- Pharmacodynamics (the effect of the investigated drug on the body) - MD expansion phase [ Time Frame: prior to dosing (week 1) and at each dosing visit (week 2-7) ] [ Designated as safety issue: No ]
| Enrollment: | 55 |
| Study Start Date: | April 2008 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Anti-IL-20 |
Drug: anti-IL-20
Anti-IL-20 in 100mg/vial for subcutaneous (under the skin) injection
|
| Placebo Comparator: Placebo |
Drug: placebo
Placebo for subcutaneous (under the skin) injection
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01261767
Locations
| United States, Alabama | |
| Novo Nordisk Clinical Trial Call Center | |
| Birmingham, Alabama, United States, 35233-2110 | |
| United States, California | |
| Novo Nordisk Clinical Trial Call Center | |
| Los Angeles, California, United States, 90036 | |
| United States, Indiana | |
| Novo Nordisk Clinical Trial Call Center | |
| Indianapolis, Indiana, United States, 46256-4697 | |
| United States, Maryland | |
| Novo Nordisk Clinical Trial Call Center | |
| Baltimore, Maryland, United States, 21225-1233 | |
| United States, Massachusetts | |
| Novo Nordisk Clinical Trial Call Center | |
| Boston, Massachusetts, United States, 02111-1526 | |
| United States, Missouri | |
| Novo Nordisk Clinical Trial Call Center | |
| Saint Louis, Missouri, United States, 63117-1206 | |
| United States, New Jersey | |
| Novo Nordisk Clinical Trial Call Center | |
| New Brunswick, New Jersey, United States, 08903 | |
| United States, New York | |
| Novo Nordisk Clinical Trial Call Center | |
| New York, New York, United States, 10010 | |
| Novo Nordisk Clinical Trial Call Center | |
| New York, New York, United States, 10029 | |
| United States, North Carolina | |
| Novo Nordisk Clinical Trial Call Center | |
| Winston Salem, North Carolina, United States, 27157 | |
| United States, Oregon | |
| Novo Nordisk Clinical Trial Call Center | |
| Portland, Oregon, United States, 97239-4501 | |
| Novo Nordisk Clinical Trial Call Center | |
| Portland, Oregon, United States, 97210-5102 | |
| United States, Utah | |
| Novo Nordisk Clinical Trial Call Center | |
| Salt Lake City, Utah, United States, 84132-0002 | |
| United States, Virginia | |
| Novo Nordisk Clinical Trial Call Center | |
| Norfolk, Virginia, United States, 23507-1970 | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Rikke Dodge, PhD | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novo Nordisk |
| ClinicalTrials.gov Identifier: | NCT01261767 History of Changes |
| Other Study ID Numbers: | NN8226-1848, U1111-1118-2792 |
| Study First Received: | December 14, 2010 |
| Last Updated: | April 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Inflammation Psoriasis Pathologic Processes Skin Diseases, Papulosquamous Skin Diseases |
ClinicalTrials.gov processed this record on June 18, 2013