NCT01282255 is a Phase 2 clinical trial of NNC109-0012 in Inflammation, sponsored by Novo Nordisk A/S.

Who is sponsoring NCT01282255?

NCT01282255 is sponsored by Novo Nordisk A/S.

What drugs are being tested in NCT01282255?

Interventions in NCT01282255: NNC109-0012, placebo.

What condition does NCT01282255 study?

NCT01282255 studies Inflammation, Rheumatoid Arthritis.

Is NCT01282255 still recruiting?

NCT01282255 is currently completed. Last updated 8 February 2017.

Last reviewed 2017-02-08 · How we verify

NCT01282255

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Last updated 8 February 2017

What this trial tests

Phase 2 trial testing NNC109-0012 in Inflammation in 67 participants. Completed in 1 January 2012.

Timeline

1 February 2011

Primary endpoint
1 January 2012

1 January 2012

Quick facts

Lead sponsor	Novo Nordisk A/S
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	67
Start date	1 February 2011
Primary completion	1 January 2012
Estimated completion	1 January 2012
Sites	29 locations across Czechia, Germany, Italy, Poland, Portugal, Romania, Spain, United Kingdom

Drugs / interventions tested

NNC109-0012 — full drug profile →
placebo

Conditions studied

Inflammation — all drugs for Inflammation →
Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

Adults 18 to 75, any sex, with Inflammation or Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting IL-10 Family Cytokines for the Treatment of Human Diseases.
Wang X, Wong K, Ouyang W, Rutz S. · · 2019 · cited 211× · PMID 29038121 · DOI 10.1101/cshperspect.a028548
The IL-20 Cytokine Family in Rheumatoid Arthritis and Spondyloarthritis.
Kragstrup TW, Andersen T, Heftdal LD, Hvid M, et al · · 2018 · cited 53× · PMID 30319661 · DOI 10.3389/fimmu.2018.02226
Efficacy and Safety of Anti-Interleukin-20 Monoclonal Antibody in Patients With Rheumatoid Arthritis: A Randomized Phase IIa Trial.
Šenolt L, Leszczynski P, Dokoupilová E, Göthberg M, et al · · 2015 · cited 37× · PMID 25707477 · DOI 10.1002/art.39083

Verify or expand the search:

Other recruiting trials for Inflammation

Currently open trials in the same condition.

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NCT07479940 — Obesity and Aging: Impacts of Nutritional Counseling and Physical Exercise on Telomeres and Senescence Parameters · NA · active not recruiting
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NCT07171450 — Cognitive Remediation · NA · recruiting
NCT07411612 — The Association Between Postoperative Inflammatory and Neurological Serum Biomarker Concentrations and Occurrence of Pos · recruiting

Other Novo Nordisk A/S trials

Trials by the same sponsor.

NCT07357740 — A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes · Phase 2 · not yet recruiting
NCT07282613 — A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adoles · Phase 3 · not yet recruiting
NCT07357766 — A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight · Phase 3 · not yet recruiting
NCT07564414 — A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obe · Phase 3 · not yet recruiting
NCT07400107 — AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Exc · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01282255 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novo Nordisk A/S
Last refreshed: 8 February 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01282255.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing