First Human Dose Trial of NNC0215-0384 in Subjects With Rheumatoid Arthritis
Status and phase
Completed
Phase 1
Conditions
Inflammation
Rheumatoid Arthritis
Treatments
Drug: NNC0215-0384
Drug: placebo
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
This trial is conducted in Europe. The aim of this trial is to describe the safety and tolerability of single intravenous (i.v.) and subcutaneous (s.c.) doses of NNC0215-0384 in subjects with active rheumatoid arthritis (RA) on background methotrexate (MTX) treatment.
Enrollment
36 patients
Sex
All
Ages
18 to 75 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Active RA, characterised by a DAS28 (CRP)(Disease Activity Score based on 28 joints and CRP) above 3.2 and a minimum of two swollen joints based on a 68/66 joint count at screening
- Concomitant treatment with MTX (7.5 - 25 mg/week both inclusive) for at least 16 weeks, with a stable dose for at least 6 weeks prior to dosing
Exclusion criteria
- Subjects with chronic inflammatory autoimmune disease other than RA
- History of or current inflammatory joint disease other than RA such as gout (crystal proven), psoriatic arthritis, juvenile idiopathic arthritis, current reactive arthritis or Lyme disease
- Any active or ongoing chronic infectious disease (e.g. chronic osteomyelitis, chronic pyelonephritis) requiring systemic anti-infectious treatment within 4 weeks prior to randomisation
- Clinically significant cardiac or cardiovascular disease
- Past or current malignancy
- Latent or active tuberculosis (TB) as documented by: A positive QuantiFeron® test (test can be performed up to 2 months prior to dosing). One retest is allowed in case of inconclusive results.- A history of active TB within the last 3 years even, if treated effectively. - A history of active TB more than 3 years ago, if there is no documentation that the prior anti-TB treatment was appropriate in duration and type
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
36 participants in 2 patient groups, including a placebo group
Active
Experimental group
Treatment:
Drug: NNC0215-0384
Drug: NNC0215-0384
Placebo
Placebo Comparator group
Treatment:
Drug: placebo
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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