Efficacy of NNC109-0012 in Subjects With Active Rheumatoid Arthritis

A Randomised, Double Blind, Placebo-controlled, Multiple Dose Trial of Anti-IL-20 (109-0012) in Subjects With Rheumatoid Arthritis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01282255

Enrollment

Registered

2011-01-24

Start date

2011-02-28

Completion date

2012-01-31

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 trial is to evaluate the change in disease activity following 12 weekly s.c. (under the skin) doses of NNC109-0012 compared to placebo in subjects with active Rheumatoid Arthritis (RA).

Interventions

DRUGNNC109-0012

The subjects will receive 12 weekly doses of 3 mg/kg of NNC109-0012 administered subcutaneously (under the skin)

DRUGplacebo

The subjects will receive 12 weekly doses of 3 mg/kg of Placebo administered subcutaneously (under the skin)

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

* Czech Republic: Age between 18 - 65 years (both inclusive) * A diagnosis of RA made at least 3 months prior to trial start * Active RA * Methotrexate treatment (between 7.5 mg and 25 mg/week, both inclusive) for at least 12 weeks with a stable dose for at least 4 weeks prior to trial start * Female subjects must be willing to avoid pregnancy and breast feeding throughout this trial at least until 15 weeks following the last dose of trial medication * Male subjects with partners of childbearing potential must be willing to use a highly effective contraception throughout trial incl. a 15 week follow up periode

Exclusion criteria

* Known or suspected allergy to trial product or related products * Body Mass Index (BMI) lower than 18.5 or higher than 35.0 kg/m\^2 * Subjects with chronic inflammatory autoimmune disease other than RA (except secondary Sjögren's syndrome or stable hypothyroidism)

Design outcomes

Primary

Measure	Time frame
Change in DAS28-CRP (disease activity score 28 calculated with C-reactive protein value)	week 0, week 12

Secondary

Measure	Time frame
Terminal serum half-life (t½)	end of treatment period
Serum levels of NNC109-0012	end of treatment period

Countries

Czechia, Germany, Italy, Poland, Portugal, Romania, Spain, United Kingdom

Outcome results

None listed

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