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

NCT01611688 | Completed Phase 1

• 3 other identifiers: NN8210-39262011-003008-19U1111-1122-3474
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (AEs)

  Up to 10 weeks after trial product administration

Secondary Outcomes (6)

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

  Up to 10 weeks after drug administration

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

  Up to 10 weeks after drug administration

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

  Up to 10 weeks after drug administration

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

  Up to 10 weeks after drug administration

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

  Up to 10 weeks after drug administration

Study Arms (2)

Active

EXPERIMENTAL

Drug: NNC0215-0384

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

NNC0215-0384 DRUG

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

Active

placebo DRUG

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

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Berlin, 10117, Germany

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Inflammation; Arthritis, Rheumatoid

Interventions

NNC0215-0384

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

Study Officials

• Global Clinical Registry (GCR,1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 1, 2012
• First Posted: June 5, 2012
• Study Start: June 4, 2012
• Primary Completion: June 17, 2013
• Study Completion: June 17, 2013
• Last Updated: February 27, 2017

Record last verified: 2017-02

Locations

DE (1)