Safety and Tolerability of Anti-IL-20 in Subjects With Rheumatoid Arthritis

Study Overview
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Brief Summary
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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.

Official Title
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A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Dose-escalation, Phase 1 Trial of Anti-IL-20 in Subjects With Rheumatoid Arthritis

Conditions
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Inflammation, Rheumatoid Arthritis

Intervention / Treatment
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* Drug: anti-IL-20
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anti-IL-20<br> | Drug: anti-IL-20<br>* 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.<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* Placebo injected subcutaneously (under the skin) with 1 dose once weekly during a 6 week period (in total 7 doses) at 2 dose levels.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 0 - 21 weeks after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Terminal serum half-life |  | 0 - 21 weeks after dosing | 
| Maximum observed serum concentration (Cmax) |  | 6 - 10 weeks after dosing | 
| Change in ACR20, ACR50 and ACR70 |  | 0-21 hours after dosing |