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

NCT00927927 | Completed Phase 1 Results

• 2 other identifiers: NN8555-36182008-008703-18
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  Adverse events were collected for a mean (min; max) of 15.7 (6.4; 42.6) weeks for single-dose subjects, and 30.6 (12.7; 43.1) for multiple-dose subjects. Visits were scheduled until receptor occupancy was below the cut-off level for receptor positivity.

Secondary Outcomes (1)

• Area Under the Concentration-time Curve (AUC)

  Data were collected from 0 hours to at least Day 43 (SD cohorts) and Day 85 (MD cohorts), and until the receptor occupancy was confirmed below the cut-off level for receptor positivity.

Study Arms (15)

SD 0.0002 mg/kg

EXPERIMENTAL

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

Drug: NNC0142-0002

SD 0.0012 mg/kg

EXPERIMENTAL

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

Drug: NNC0142-0002

SD 0.007 mg/kg

EXPERIMENTAL

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

Drug: NNC0142-0002

SD 0.035 mg/kg

EXPERIMENTAL

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

Drug: NNC0142-0002

SD 0.175 mg/kg

EXPERIMENTAL

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

Drug: NNC0142-0002

SD 0.7 mg/kg

EXPERIMENTAL

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

Drug: NNC0142-0002

SD 2.5 mg/kg

EXPERIMENTAL

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

Drug: NNC0142-0002

SD 7.5 mg/kg

EXPERIMENTAL

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

Drug: NNC0142-0002

SD Placebo

EXPERIMENTAL

Subjects were injected once with placebo

Drug: placebo

MD 0.02 mg/kg

EXPERIMENTAL

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

Drug: NNC0142-0002

MD 0.3 mg/kg

EXPERIMENTAL

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

Drug: NNC0142-0002

MD 1.0 mg/kg

EXPERIMENTAL

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

Drug: NNC0142-0002

MD 1.6 mg/kg

EXPERIMENTAL

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

Drug: NNC0142-0002

MD 4.0 mg/kg

EXPERIMENTAL

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

Drug: NNC0142-0002

MD Placebo

EXPERIMENTAL

Subjects were injected biweekly four times with placebo

Drug: placebo

Interventions

NNC0142-0002 DRUG

Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1

SD 0.0002 mg/kg

placebo DRUG

Single dose of 0 mg/kg administered subcutaneously (under the skin); cohort 1-7b on day 1, cohort 8-11 biweekly four times

SD Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Berlin, 10117, Germany

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Inflammation; Arthritis, Rheumatoid

Interventions

NNC0142-0002 monoclonal antibody

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

Maximum tolerated dose was not reached.

Results Point of Contact

• Title: Public Access to Clinical Trials
• Organization: Novo Nordisk A/S

RA-RNDUS-ClinTriDisc@ITS.JNJ.com

Study Officials

• Britta Væver Bysted, DVM, PhD

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2009
• First Posted: June 25, 2009
• Study Start: June 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 3, 2016
• Results First Posted: October 21, 2013

Record last verified: 2016-08

Locations

DE (1)