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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01611688
• Other study ID #: NN8210-3926
• Secondary ID: 2011-003008-19U1
• Status: Completed
• Phase: Phase 1
• First received: June 1, 2012
• Last updated: February 23, 2017
• Start date: June 4, 2012
• Est. completion date: June 17, 2013

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 17, 2013
• Est. primary completion date: June 17, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Inflammation
• Rheumatoid Arthritis

Intervention

Drug:
• NNC0215-0384
I.v.(intravenous) dose-escalation. Highest dose planned for i.v. administration is 10 mg/kg
• placebo
Administered i.v.(intravenous) or s.c. (subcutaneous, under the skin).
• 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

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (AEs)		Up to 10 weeks after trial product administration
Secondary	I.v. administration: AUC, Area under the curve		Up to 10 weeks after drug administration
Secondary	I.v. administration: terminal half-life (t½)		Up to 10 weeks after drug administration
Secondary	S.c. administration: AUC, Area under the curve		Up to 10 weeks after drug administration
Secondary	S.c. administration: terminal half-life (t½)		Up to 10 weeks after drug administration
Secondary	Maximum level and duration of full C5a receptor (C5aR) occupancy by NNC0215-0384 on neutrophils		Up to 10 weeks after drug administration
Secondary	Maximum and minimum levels of relevant serum and plasma biomarkers related to NNC0215-0384 safety, efficacy or mechanism of action (MoA)		Up to 10 weeks after drug administration

External Links

•   Clinical Trials at Novo Nordisk