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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01611688
First received: June 1, 2012
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Inflammation
Rheumatoid Arthritis
Drug: NNC0215-0384
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: First Human Dose Trial of NNC0215-0384 in Subjects With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Incidence of adverse events (AEs) [ Time Frame: Up to 10 weeks after trial product administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • I.v. administration: AUC, Area under the curve [ Time Frame: Up to 10 weeks after drug administration ] [ Designated as safety issue: No ]
  • I.v. administration: terminal half-life (t½) [ Time Frame: Up to 10 weeks after drug administration ] [ Designated as safety issue: No ]
  • S.c. administration: AUC, Area under the curve [ Time Frame: Up to 10 weeks after drug administration ] [ Designated as safety issue: No ]
  • S.c. administration: terminal half-life (t½) [ Time Frame: Up to 10 weeks after drug administration ] [ Designated as safety issue: No ]
  • Maximum level and duration of full C5a receptor (C5aR) occupancy by NNC0215-0384 on neutrophils [ Time Frame: Up to 10 weeks after drug administration ] [ Designated as safety issue: No ]
  • Maximum and minimum levels of relevant serum and plasma biomarkers related to NNC0215-0384 safety, efficacy or mechanism of action (MoA) [ Time Frame: Up to 10 weeks after drug administration ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: June 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Drug: NNC0215-0384
I.v.(intravenous) dose-escalation. Highest dose planned for i.v. administration is 10 mg/kg
Drug: NNC0215-0384
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
Placebo Comparator: Placebo Drug: placebo
Administered i.v.(intravenous) or s.c. (subcutaneous, under the skin).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01611688

Locations
Germany
Berlin, Germany, 10117
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Cecilie Freddie Lange Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01611688     History of Changes
Other Study ID Numbers: NN8210-3926, 2011-003008-19, U1111-1122-3474
Study First Received: June 1, 2012
Last Updated: November 14, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Inflammation
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 20, 2014