NCT01955603

Brief Summary

This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC0215-0384 administered to subjects with moderate to severe rheumatoid arthritis (RA) concomitantly treated with methotrexate (MTX).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2013

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 7, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 15, 2014

Status Verified

October 1, 2014

Enrollment Period

1.1 years

First QC Date

September 24, 2013

Last Update Submit

October 14, 2014

Conditions

InflammationRheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events (AEs)

    From first dosing until 19 weeks after first dosing

Secondary Outcomes (5)

  • Concentration of NNC0215-0384 in serum

    7 days after each dose

  • Concentration of NNC0215-0384 in serum

    3 days after first and last dose

  • Duration of full and duration of detectable levels of C5a receptor (C5aR) occupancy by NNC0215-0384 on neutrophils from baseline

    From week 0 until 19 weeks after first dosing

  • Change in health assessment questionnaire - disability index (HAQ-DI) from baseline

    Week 0, week 7 first dosing

  • Incidence and characterisation of antibodies directed against NNC0215-0384 and, if present, their in vitro neutralising activity

    From first dosing until 19 weeks after first dosing

Study Arms (3)

Dose level 1

EXPERIMENTAL
Drug: NNC0215-0384Drug: placebo

Dose level 2

EXPERIMENTAL
Drug: NNC0215-0384Drug: placebo

Dose level 3

EXPERIMENTAL
Drug: NNC0215-0384Drug: placebo

Interventions

NNC0215-0384DRUG

A total of seven once-weekly doses of NNC0215-0384 or placebo will be administered subcutaneously (s.c., under the skin) at one of three ascending dose levels. Each cohort will consist of eight subjects randomised to either active (6 subjects) or placebo (2 subjects) treatment. Each subject will participate in one cohort only. Dose-escalation to the next dose level will be initiated when the safety data has been evaluated and if considered safe.

Dose level 1Dose level 2Dose level 3
placeboDRUG

Placebo administered corresponding to NNC0215-0384 treatment

Dose level 1Dose level 2Dose level 3

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, age between 18 and 75 years (both years inclusive), for Russia only: Age between 18-65 years (both years inclusive)
  • Moderate to severe RA, confirmed by a Disease Activity Score based on 28 joints and C-reactive protein (DAS28 (CRP)) equal to or above 4.5 and a minimum of five tender and five swollen joints based on a 28 joint count (a joint can score as both tender and swollen)
  • MTX (10-25 mg/week both inclusive) for at least 16 weeks, with an unchanged dose for at least 6 weeks prior to screening and until randomisation
  • Females who are not of child-bearing potential must have been post-menopausal for at least 1 year confirmed by follicle-stimulating hormone (FSH) equal to or above 26.7 U/L or be surgically sterile

You may not qualify if:

  • Past or current inflammatory joint disease other than RA (e.g. gout \[crystal proven\], psoriatic arthritis, juvenile idiopathic arthritis, reactive arthritis or Lyme disease
  • Any active or ongoing chronic infectious disease (e.g. chronic osteomyelitis, chronic pyelonephritis) within 4 weeks prior to randomisation
  • Clinically significant cardiac or cardiovascular disease
  • Past or current malignancy
  • Evaluation of tuberculosis screening indicative of latent or active tuberculosis (TB)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Berlin, 13353, Germany

Location

Unknown Facility

Budapest, H1027, Hungary

Location

Unknown Facility

Krakow, 31-637, Poland

Location

Unknown Facility

Moscow, 119435, Russia

Location

Related Links

MeSH Terms

Conditions

InflammationArthritis, Rheumatoid

Interventions

NNC0215-0384

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune 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

September 24, 2013

First Posted

October 7, 2013

Study Start

September 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 15, 2014

Record last verified: 2014-10

Locations

DE(1)HU(1)PL(1)RU(1)