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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01038674

Enrollment

Registered

2009-12-24

Start date

2010-02-28

Completion date

2010-12-31

Last updated

2017-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation, Rheumatoid Arthritis

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.

Interventions

DRUGanti-IL-20

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.

DRUGplacebo

Placebo injected subcutaneously (under the skin) with 1 dose once weekly during a 6 week period (in total 7 doses) at 2 dose levels.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Adverse events	0 - 21 weeks after dosing

Secondary

Measure	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

Countries

Belgium, Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026