A Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0215-0384 Administered to Subjects With Moderate to Severe Rheumatoid Arthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-10-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Inflammation Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dose level 1

Group Type EXPERIMENTAL

NNC0215-0384

Intervention Type DRUG

A total of seven once-weekly doses of NNC0215-0384 or placebo will be administered subcutaneously (s.c., under the skin) at one of three ascending dose levels. Each cohort will consist of eight subjects randomised to either active (6 subjects) or placebo (2 subjects) treatment. Each subject will participate in one cohort only. Dose-escalation to the next dose level will be initiated when the safety data has been evaluated and if considered safe.

placebo

Intervention Type DRUG

Placebo administered corresponding to NNC0215-0384 treatment

Dose level 2

Group Type EXPERIMENTAL

NNC0215-0384

Intervention Type DRUG

A total of seven once-weekly doses of NNC0215-0384 or placebo will be administered subcutaneously (s.c., under the skin) at one of three ascending dose levels. Each cohort will consist of eight subjects randomised to either active (6 subjects) or placebo (2 subjects) treatment. Each subject will participate in one cohort only. Dose-escalation to the next dose level will be initiated when the safety data has been evaluated and if considered safe.

placebo

Intervention Type DRUG

Placebo administered corresponding to NNC0215-0384 treatment

Dose level 3

Group Type EXPERIMENTAL

NNC0215-0384

Intervention Type DRUG

A total of seven once-weekly doses of NNC0215-0384 or placebo will be administered subcutaneously (s.c., under the skin) at one of three ascending dose levels. Each cohort will consist of eight subjects randomised to either active (6 subjects) or placebo (2 subjects) treatment. Each subject will participate in one cohort only. Dose-escalation to the next dose level will be initiated when the safety data has been evaluated and if considered safe.

placebo

Intervention Type DRUG

Placebo administered corresponding to NNC0215-0384 treatment

Interventions

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NNC0215-0384

A total of seven once-weekly doses of NNC0215-0384 or placebo will be administered subcutaneously (s.c., under the skin) at one of three ascending dose levels. Each cohort will consist of eight subjects randomised to either active (6 subjects) or placebo (2 subjects) treatment. Each subject will participate in one cohort only. Dose-escalation to the next dose level will be initiated when the safety data has been evaluated and if considered safe.

Intervention Type DRUG

placebo

Placebo administered corresponding to NNC0215-0384 treatment

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No