Rheumatoid arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: NNC151-0000
Product Code: NNC0151-0000-0000
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: NNC0151-0000-0000
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • A diagnosis of rheumatoid arthritis according to the American College of Rheumatology (ACR1987 classification), made at least three months prior to randomisation. • Active RA, characterized by a DAS28 score =3.2 • Male and female subjects • Age between 18 and 75 years (both inclusive) • Subjects are on stable doses of methotrexate (up to and including 25 mg/week) for at least 4 weeks prior to dosing Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known or suspected allergy to trial product or related products 2. Subjects with chronic inflammatory autoimmune disease other than RA (except secondary Sjögren's syndrome or stable hypothyroidism) 3. History of or current inflammatory joint disease other than RA (eg. gout (crystal proven), psoriatic, juvenile arthritis), current reactive arthritis or Lyme disease 4. Body mass index (BMI) 38.0 kg/m² (inclusive) 5. Chronic or ongoing active infectious disease requiring systemic anti-infectious treatment within 2 weeks prior to randomisation 6. History of severe systemic bacterial, viral or fungal infections within the past 12 months prior to randomisation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability, including immunogenicity, of NNC151-0000 after four multiple doses at up to seven dose levels in subjects with active RA.; Secondary Objective: To assess the pharmacodynamics of NNC151-0000 (PD) including - C5aR occupancy on neutrophils and monocytes - effect on various biomarkers, including acute phase cytokines and immunophenotyping • to assess the PK of NNC151-0000 • to assess the preliminary clinical improvement and efficacy of NNC151-0000 in subjects with RA using the ACR20/50/70 and ACR-N scores and DAS28. ; Primary end point(s): Adverse events (AEs) and toxicity (by use of National Cancer Institute’s CTCAE scale, version 3 including - local tolerability at injection site - vital signs (blood pressure (BP), pulse and body temperature) and body weight - ECG - haematology, biochemistry including CRP, Hs-CRP and lipids, urinalysis - acute phase cytokine response (IL-1ß, IL-6, TNF-a, INF-?) - complement markers (e.g. C5a-desArg, C3 and total haemolytic complement titre (CH50) - immunogenicity (antibodies to NNC151-0000). The Immunogenicity samples will be analysed at Novo Nordisk A/S. The analysis for antibodies will be performed after completion of each dose level during dose escalation. | — |
Countries
Czech Republic, Denmark, Germany, Hungary, Poland, Romania, Russian Federation, Ukraine, United Kingdom
Outcome results
None listed