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

Primary Purpose

Inflammation, Rheumatoid Arthritis

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

NNC0215-0384

placebo

NNC0215-0384

About this trial

This is an interventional treatment trial for Inflammation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Incidence of adverse events (AEs)

Secondary Outcome Measures

I.v. administration: AUC, Area under the curve

I.v. administration: terminal half-life (t½)

S.c. administration: AUC, Area under the curve

S.c. administration: terminal half-life (t½)

Maximum level and duration of full C5a receptor (C5aR) occupancy by NNC0215-0384 on neutrophils

Maximum and minimum levels of relevant serum and plasma biomarkers related to NNC0215-0384 safety, efficacy or mechanism of action (MoA)

Full Information

NCT ID

NCT01611688

First Posted

June 1, 2012

Last Updated

February 23, 2017

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT01611688

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

June 4, 2012 (Actual)

Primary Completion Date

June 17, 2013 (Actual)

Study Completion Date

June 17, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammation, Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

NNC0215-0384

Intervention Description

I.v.(intravenous) dose-escalation. Highest dose planned for i.v. administration is 10 mg/kg

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Administered i.v.(intravenous) or s.c. (subcutaneous, under the skin).

Intervention Type

Drug

Intervention Name(s)

NNC0215-0384

Intervention Description

The s.c. (subcutaneous, under the skin) part will not start until at least two i.v. dose levels have been evaluated for safety and pharmacokinetics. Highest dose planned for s.c. administration is 4 mg/kg

Primary Outcome Measure Information:

Title

Incidence of adverse events (AEs)

Time Frame

Up to 10 weeks after trial product administration

Secondary Outcome Measure Information:

Title

I.v. administration: AUC, Area under the curve

Time Frame