First Human Dose Trial of NNC0215-0384 in Subjects With Rheumatoid Arthritis

Phase 1

Completed

• Conditions: Inflammation; Rheumatoid Arthritis
• Interventions: Drug: NNC0215-0384; Drug: placebo

• Registration Number: NCT01611688
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-01
• Study First Submitted QC: 2012-06-01
• Study Start: 2012-06-04
• Study First Posted: 2012-06-05
• Primary Completion: 2013-06-17
• Study Completion: 2013-06-17
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	NNC0215-0384	-
Placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs)	Up to 10 weeks after trial product administration

Secondary Outcome Measures

Name	Time	Method
Maximum level and duration of full C5a receptor (C5aR) occupancy by NNC0215-0384 on neutrophils	Up to 10 weeks after drug administration
Maximum and minimum levels of relevant serum and plasma biomarkers related to NNC0215-0384 safety, efficacy or mechanism of action (MoA)	Up to 10 weeks after drug administration
I.v. administration: AUC, Area under the curve	Up to 10 weeks after drug administration
I.v. administration: terminal half-life (t½)	Up to 10 weeks after drug administration
S.c. administration: AUC, Area under the curve	Up to 10 weeks after drug administration
S.c. administration: terminal half-life (t½)	Up to 10 weeks after drug administration

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Berlin, Germany