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First-in-man Trial of NNC0142-0002 in Patients With Rheumatoid Arthritis

Primary Purpose

Inflammation, Rheumatoid Arthritis

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

NNC0142-0002

placebo

NNC0142-0002

placebo

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 rheumatoid arthritis, characterized by a Disease Activity Score (DAS28) above 3.2, and a diagnosis of at least three months duration
Aged between 18 and 75 years (both inclusive)
Subjects on stable doses of methotrexate for at least 4 weeks prior to dosing
Use of highly effective contraception during the trial (both males and females)

Exclusion Criteria:

A chronic inflammatory autoimmune or joint disease other than RA (rheumatoid arthritis)
An active or latent tuberculosis
Any investigational or experimental therapy within 4 weeks or 5 half-lives (whichever is longer) prior to the screening visit
A known significant cardio-vascular disease
Vaccination against live virus or bacteria within 4 weeks prior to randomization
The use of concomitant medications that are prohibited in the trial (e.g., certain DMARDs (antirheumatic therapies that are disease modifying), biologics (here: biotechnologically produced antibodies), intra-articular corticoid-injections, etc.)
A positive test result for human immunodeficiency virus (HIV) infection, hepatitis B and/or hepatitis C, or tuberculosis skin test
Donation of greater than or equal to 400 ml of blood within 8 weeks prior to trial entry

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm Type

Experimental

Arm Label

SD 0.0002 mg/kg

SD 0.0012 mg/kg

SD 0.007 mg/kg

SD 0.035 mg/kg

SD 0.175 mg/kg

SD 0.7 mg/kg

SD 2.5 mg/kg

SD 7.5 mg/kg

SD Placebo

MD 0.02 mg/kg

MD 0.3 mg/kg

MD 1.0 mg/kg

MD 1.6 mg/kg

MD 4.0 mg/kg

MD Placebo

Arm Description

Subjects were injected once with NNC0142-0002 at a dose of 0.0002 mg/kg

Subjects were injected once with NNC0142-0002 at a dose of 0.0012 mg/kg

Subjects were injected once with NNC0142-0002 at a dose of 0.007 mg/kg

Subjects were injected once with NNC0142-0002 at a dose of 0.035 mg/kg

Subjects were injected once with NNC0142-0002 at a dose of 0.175 mg/kg

Subjects were injected once with NNC0142-0002 at a dose of 0.7 mg/kg

Subjects were injected once with NNC0142-0002 at a dose of 2.5 mg/kg

Subjects were injected once with NNC0142-0002 at a dose of 7.5 mg/kg

Subjects were injected once with placebo

Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg

Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg

Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg

Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg

Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg

Subjects were injected biweekly four times with placebo

Outcomes

Primary Outcome Measures

Frequency of Adverse Events

Adverse event: any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. Serious AE: AE that at any dose level resulted in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event that may jeopardize the subject and require medical or surgical intervention.

Secondary Outcome Measures

Area Under the Concentration-time Curve (AUC)

Systemic exposure to NNC0142-0002.

Full Information

NCT ID

NCT00927927

First Posted

June 24, 2009

Last Updated

August 24, 2016

Sponsor

Janssen Research & Development, LLC

1. Study Identification

Unique Protocol Identification Number

NCT00927927

Brief Title

First-in-man Trial of NNC0142-0002 in Patients With Rheumatoid Arthritis

Official Title

A Randomized, Double-blind, Placebo-controlled, Dose-escalation, Single and Multiple Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0142-0002 Administered Subcutaneously to Subjects With Rheumatoid Arthritis

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Research & Development, LLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetic (the effect of the body on the investigated drug) and signs of clinical efficacy of increasing single doses or four repeated doses of NNC 0142-0002 in patients with rheumatoid arthritis.

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

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

65 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SD 0.0002 mg/kg

Arm Type

Experimental

Arm Description

Subjects were injected once with NNC0142-0002 at a dose of 0.0002 mg/kg

Arm Title

SD 0.0012 mg/kg

Arm Type

Experimental

Arm Description

Subjects were injected once with NNC0142-0002 at a dose of 0.0012 mg/kg

Arm Title

SD 0.007 mg/kg

Arm Type

Experimental

Arm Description

Subjects were injected once with NNC0142-0002 at a dose of 0.007 mg/kg

Arm Title

SD 0.035 mg/kg

Arm Type

Experimental

Arm Description

Subjects were injected once with NNC0142-0002 at a dose of 0.035 mg/kg

Arm Title

SD 0.175 mg/kg

Arm Type

Experimental

Arm Description

Subjects were injected once with NNC0142-0002 at a dose of 0.175 mg/kg

Arm Title

SD 0.7 mg/kg

Arm Type

Experimental

Arm Description

Subjects were injected once with NNC0142-0002 at a dose of 0.7 mg/kg

Arm Title

SD 2.5 mg/kg

Arm Type

Experimental

Arm Description

Subjects were injected once with NNC0142-0002 at a dose of 2.5 mg/kg

Arm Title

SD 7.5 mg/kg

Arm Type

Experimental

Arm Description

Subjects were injected once with NNC0142-0002 at a dose of 7.5 mg/kg

Arm Title

SD Placebo

Arm Type

Experimental

Arm Description

Subjects were injected once with placebo

Arm Title

MD 0.02 mg/kg

Arm Type

Experimental

Arm Description

Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg

Arm Title

MD 0.3 mg/kg

Arm Type

Experimental

Arm Description

Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg

Arm Title

MD 1.0 mg/kg

Arm Type

Experimental

Arm Description

Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg

Arm Title

MD 1.6 mg/kg

Arm Type

Experimental

Arm Description

Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg

Arm Title

MD 4.0 mg/kg

Arm Type

Experimental

Arm Description

Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg

Arm Title

MD Placebo

Arm Type

Experimental

Arm Description

Subjects were injected biweekly four times with placebo

Intervention Type

Drug

Intervention Name(s)

NNC0142-0002

Intervention Description