Back to resultsSafety and Tolerability of Anti-IL-20 in Subjects With Rheumatoid Arthritis
Primary Purpose
Inflammation, Rheumatoid Arthritis
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
anti-IL-20
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Inflammation
Eligibility Criteria
Inclusion Criteria:
- Informed consent obtained before any trial-related activities
- A diagnosis of rheumatoid arthritis made at least 3 months prior to screening
- Active rheumatoid arthritis, characterised by a DAS28 equal or above 3.2
- Methotrexate treatment (stable dose, equal or below 25 mg/week) for at least 4 weeks prior to study start (subjects receiving stable doses of oral corticosteroids, and/or non-steroidal anti-inflammatory drugs and/or acetaminophen and/or opioids according to prescribed recommended doses can be included)
- Male subjects and female subjects of non-child bearing potential
Exclusion Criteria:
- Body mass index (BMI) less than 18.5 or above 35.0 kg/m2
- Subjects with chronic inflammatory autoimmune disease other than rheumatoid arthritis
- History of or current inflammatory joint disease other than rheumatoid arthritis
- Chronic or ongoing infectious disease requiring systemic anti-infectious treatment within 2 weeks prior to study start
- Past or current malignancy (as judged by the investigator)
- Clinically significant cardiac or cardiovascular disease
- Positive for human immunodeficiency virus (HIV), hepatitis or tuberculosis
- Blood donation or blood loss of more than 0.45L within 2 months prior to study start, or longer if required by local regulations
- Breast-feeding women
Sites / Locations
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Anti-IL-20
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Adverse events
Secondary Outcome Measures
Terminal serum half-life
Maximum observed serum concentration (Cmax)
Change in ACR20, ACR50 and ACR70
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01038674
Brief Title
Safety and Tolerability of Anti-IL-20 in Subjects With Rheumatoid Arthritis
Official Title
A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Dose-escalation, Phase 1 Trial of Anti-IL-20 in Subjects With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety and tolerability of the drug Anti-IL-20 in subjects with rheumatoid arthritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anti-IL-20
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
anti-IL-20
Intervention Description
Anti-IL-20 injected subcutaneously (under the skin) with 1 dose once weekly during a 6 week period (in total 7 doses) at 2 dose levels.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo injected subcutaneously (under the skin) with 1 dose once weekly during a 6 week period (in total 7 doses) at 2 dose levels.
Primary Outcome Measure Information:
Title
Adverse events
Time Frame
0 - 21 weeks after dosing
Secondary Outcome Measure Information:
Title
Terminal serum half-life
Time Frame
0 - 21 weeks after dosing
Title
Maximum observed serum concentration (Cmax)
Time Frame
6 - 10 weeks after dosing
Title
Change in ACR20, ACR50 and ACR70
Time Frame
0-21 hours after dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed consent obtained before any trial-related activities
A diagnosis of rheumatoid arthritis made at least 3 months prior to screening
Active rheumatoid arthritis, characterised by a DAS28 equal or above 3.2
Methotrexate treatment (stable dose, equal or below 25 mg/week) for at least 4 weeks prior to study start (subjects receiving stable doses of oral corticosteroids, and/or non-steroidal anti-inflammatory drugs and/or acetaminophen and/or opioids according to prescribed recommended doses can be included)
Male subjects and female subjects of non-child bearing potential
Exclusion Criteria:
Body mass index (BMI) less than 18.5 or above 35.0 kg/m2
Subjects with chronic inflammatory autoimmune disease other than rheumatoid arthritis
History of or current inflammatory joint disease other than rheumatoid arthritis
Chronic or ongoing infectious disease requiring systemic anti-infectious treatment within 2 weeks prior to study start
Past or current malignancy (as judged by the investigator)
Clinically significant cardiac or cardiovascular disease
Positive for human immunodeficiency virus (HIV), hepatitis or tuberculosis
Blood donation or blood loss of more than 0.45L within 2 months prior to study start, or longer if required by local regulations
Breast-feeding women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Warszawa
ZIP/Postal Code
PL-02-274
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
25749867
Citation
Lundblad MS, Overgaard RV, Gothberg M, Fjording MS, Watson E. Clinical pharmacokinetics of the anti-interleukin-20 monoclonal antibody NNC0109-0012 in healthy volunteers and patients with psoriasis or rheumatoid arthritis. Adv Ther. 2015 Mar;32(3):228-38. doi: 10.1007/s12325-015-0191-7. Epub 2015 Mar 7.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Safety and Tolerability of Anti-IL-20 in Subjects With Rheumatoid Arthritis
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