First-in-man Trial of NNC0142-0002 in Patients With Rheumatoid Arthritis

A Randomized, Double-blind, Placebo-controlled, Dose-escalation, Single and Multiple Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0142-0002 Administered Subcutaneously to Subjects With Rheumatoid Arthritis

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetic (the effect of the body on the investigated drug) and signs of clinical efficacy of increasing single doses or four repeated doses of NNC 0142-0002 in patients with rheumatoid arthritis.

Inclusion Criteria:

• Active rheumatoid arthritis, characterized by a Disease Activity Score (DAS28) above 3.2, and a diagnosis of at least three months duration
• Aged between 18 and 75 years (both inclusive)
• Subjects on stable doses of methotrexate for at least 4 weeks prior to dosing
• Use of highly effective contraception during the trial (both males and females)

Exclusion Criteria:

• A chronic inflammatory autoimmune or joint disease other than RA (rheumatoid arthritis)
• An active or latent tuberculosis
• Any investigational or experimental therapy within 4 weeks or 5 half-lives (whichever is longer) prior to the screening visit
• A known significant cardio-vascular disease
• Vaccination against live virus or bacteria within 4 weeks prior to randomization
• The use of concomitant medications that are prohibited in the trial (e.g., certain DMARDs (antirheumatic therapies that are disease modifying), biologics (here: biotechnologically produced antibodies), intra-articular corticoid-injections, etc.)
• A positive test result for human immunodeficiency virus (HIV) infection, hepatitis B and/or hepatitis C, or tuberculosis skin test
• Donation of greater than or equal to 400 ml of blood within 8 weeks prior to trial entry