A Randomised, Placebo-controlled, Double-blind Within Cohort, Dose Escalation, Multiple-dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0215-0384 Administered Subcutaneously to Subjects With Moderate to Severe Rheumatoid Arthritis

Novo Nordisk A/S0 sites24 target enrollmentSeptember 2013

ConditionsInflammation Rheumatoid Arthritis

InterventionsNNC0215-0384 placebo

DrugsNNC0215-0384 placebo

Overview

Phase: Phase 1
Intervention: NNC0215-0384
Conditions: Inflammation
Sponsor: Novo Nordisk A/S
Enrollment: 24
Primary Endpoint: Incidence of adverse events (AEs)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC0215-0384 administered to subjects with moderate to severe rheumatoid arthritis (RA) concomitantly treated with methotrexate (MTX).

Registry

clinicaltrials.gov

Start Date

September 2013

End Date

October 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female, age between 18 and 75 years (both years inclusive), for Russia only: Age between 18-65 years (both years inclusive)
•Moderate to severe RA, confirmed by a Disease Activity Score based on 28 joints and C-reactive protein (DAS28 (CRP)) equal to or above 4.5 and a minimum of five tender and five swollen joints based on a 28 joint count (a joint can score as both tender and swollen)
•MTX (10-25 mg/week both inclusive) for at least 16 weeks, with an unchanged dose for at least 6 weeks prior to screening and until randomisation
•Females who are not of child-bearing potential must have been post-menopausal for at least 1 year confirmed by follicle-stimulating hormone (FSH) equal to or above 26.7 U/L or be surgically sterile

Exclusion Criteria

•Past or current inflammatory joint disease other than RA (e.g. gout \[crystal proven\], psoriatic arthritis, juvenile idiopathic arthritis, reactive arthritis or Lyme disease
•Any active or ongoing chronic infectious disease (e.g. chronic osteomyelitis, chronic pyelonephritis) within 4 weeks prior to randomisation
•Clinically significant cardiac or cardiovascular disease
•Past or current malignancy
•Evaluation of tuberculosis screening indicative of latent or active tuberculosis (TB)

Arms & Interventions

Dose level 1

Intervention: NNC0215-0384

Dose level 1

Intervention: placebo

Dose level 2

Intervention: NNC0215-0384

Dose level 2

Intervention: placebo

Dose level 3

Intervention: NNC0215-0384

Dose level 3

Intervention: placebo

Outcomes

Primary Outcomes

Incidence of adverse events (AEs)

Time Frame: From first dosing until 19 weeks after first dosing

Secondary Outcomes

Concentration of NNC0215-0384 in serum(3 days after first and last dose)
Incidence and characterisation of antibodies directed against NNC0215-0384 and, if present, their in vitro neutralising activity(From first dosing until 19 weeks after first dosing)
Duration of full and duration of detectable levels of C5a receptor (C5aR) occupancy by NNC0215-0384 on neutrophils from baseline(From week 0 until 19 weeks after first dosing)
Change in health assessment questionnaire - disability index (HAQ-DI) from baseline(Week 0, week 7 first dosing)