Rheumatoid arthritis MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
Conditions
Interventions
Product Name: Anti-IL-20 (109-0012)
Product Code: NNC 0109-0000-0012
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: NNC 0109-0000-0012
Other descriptive name: Anti-IL-20
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A diagnosis of RA according to the American College of Rheumatology (ACR1987 classification) made at least 3 month’s prior to screening. 2. Active RA, characterised by a DAS28-CRP =3.2 and = 4 swollen and = 4 tender joints of the 28 joint count 3. Methotrexate treatment (=7.5 mg - = 25 mg/week) for at least 12 weeks, with a stable dose for at least 4 weeks prior to screening 4. Aged between 18 and 75 years (both years inclusive) 5. Male and female subjects must be willing to avoid pregnancy and breast feeding throughout this trial at least until 15 weeks following the last dose of study medication 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. Body mass index (BMI) 35.0 kg/m2 2. Subjects with chronic inflammatory autoimmune disease other than RA 3. History of or current inflammatory joint disease other than RA (e.g. gout, psoriatic or reactive arthritis, Lyme disease, juvenile ideopathic arthritis) 4. Chronic or ongoing infectious disease requiring systemic anti-infectious treatment within 2 weeks prior to screening 5. History of severe systemic bacterial, viral or fungal infections within the past 12 months prior to screening 6. Evidence of herpes zoster or cytomegalovirus infection that resolved less than 2 months prior to screening 7. Past or current malignancy 8. An adequate treatment duration of a biologic DMARD with an inadequate response (treatment failure) defined at the Investigator’s discretion 9. Clinically significant cardiac or cardiovascular disease 10. Positive for human immunodeficiency virus (HIV) 11. Positive test (serology and/or PCR) results for Hepatitis B or Hepatitis C 12. Positive purified protein derivative (PPD) tuberculin skin test 13. Blood donation or blood loss of more than 0.45 L within 2 months prior to screening, or longer if required by local regulations 14. Breast-feeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: • To assess signs of clinical efficacy as determined by change in disease activity (ACR scores), clinical responses (EULAR response criteria) and PD biomarkers during and after 12 repeated doses of NNC109-0012 • To assess safety and tolerability during and after 12 repeated doses of NNC109-0012 • To assess the pharmacokinetic (PK) profile of NNC109-0012 after 12 repeated doses of NNC109-0012 • To assess potential immunogenicity of NNC109-0012 during and after 12 repeated doses of NNC109-0012.;Main Objective: To evaluate the change in disease activity following 12 weekly s.c. doses of NNC109-0012 3mg/kg compared to placebo in subjects with active RA on stable background MTX therapy.;Primary end point(s): Change in DAS28-CRP from baseline to week 12 | — |
Countries
Czech Republic, Hungary, Italy, Portugal, Spain, United Kingdom
Outcome results
None listed