First-in-man Trial of NNC0142-0002 in Patients With Rheumatoid Arthritis
Status and phase
Completed
Phase 1
Conditions
Inflammation
Rheumatoid Arthritis
Treatments
Drug: placebo
Drug: NNC0142-0002
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
65 patients
Sex
All
Ages
18 to 75 years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Single Group Assignment
Masking
Double Blind
65 participants in 15 patient groups
SD 0.0002 mg/kg
Experimental group
Description:
Subjects were injected once with NNC0142-0002 at a dose of 0.0002 mg/kg
Treatment:
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
SD 0.0012 mg/kg
Experimental group
Description:
Subjects were injected once with NNC0142-0002 at a dose of 0.0012 mg/kg
Treatment:
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
SD 0.007 mg/kg
Experimental group
Description:
Subjects were injected once with NNC0142-0002 at a dose of 0.007 mg/kg
Treatment:
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
SD 0.035 mg/kg
Experimental group
Description:
Subjects were injected once with NNC0142-0002 at a dose of 0.035 mg/kg
Treatment:
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
SD 0.175 mg/kg
Experimental group
Description:
Subjects were injected once with NNC0142-0002 at a dose of 0.175 mg/kg
Treatment:
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
SD 0.7 mg/kg
Experimental group
Description:
Subjects were injected once with NNC0142-0002 at a dose of 0.7 mg/kg
Treatment:
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
SD 2.5 mg/kg
Experimental group
Description:
Subjects were injected once with NNC0142-0002 at a dose of 2.5 mg/kg
Treatment:
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
SD 7.5 mg/kg
Experimental group
Description:
Subjects were injected once with NNC0142-0002 at a dose of 7.5 mg/kg
Treatment:
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
SD Placebo
Experimental group
Description:
Subjects were injected once with placebo
Treatment:
Drug: placebo
Drug: placebo
MD 0.02 mg/kg
Experimental group
Description:
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg
Treatment:
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
MD 0.3 mg/kg
Experimental group
Description:
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg
Treatment:
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
MD 1.0 mg/kg
Experimental group
Description:
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg
Treatment:
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
MD 1.6 mg/kg
Experimental group
Description:
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg
Treatment:
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
MD 4.0 mg/kg
Experimental group
Description:
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg
Treatment:
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
Drug: NNC0142-0002
MD Placebo
Experimental group
Description:
Subjects were injected biweekly four times with placebo
Treatment:
Drug: placebo
Drug: placebo
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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