First-in-man Trial of NNC0142-0002 in Patients With Rheumatoid Arthritis
Condition: Inflammation; Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Inflammation
Intervention: NNC0142-0002; NNC0142-0002; NNC0142-0002; NNC0142-0002; NNC0142-0002; NNC0142-0002; NNC0142-0002; NNC0142-0002; placebo; NNC0142-0002; NNC0142-0002; NNC0142-0002; NNC0142-0002; NNC0142-0002; placebo
Intervention description: Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1; Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1; Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1; Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1; Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1; Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1; Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1; Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1; Single dose of 0 mg/kg administered subcutaneously (under the skin); cohort 1-7b on day 1, cohort 8-11 biweekly four times; Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly; Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly; Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly; Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly; Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly; Single dose of 0 mg/kg administered subcutaneously (under the skin); cohort 1-7b on day 1, cohort 8-11 biweekly four times
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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