Back to resultsA Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0215-0384 Administered to Subjects With Moderate to Severe Rheumatoid Arthritis
Primary Purpose
Inflammation, Rheumatoid Arthritis
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
NNC0215-0384
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Inflammation
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Dose level 1
Dose level 2
Dose level 3
Arm Description
Outcomes
Primary Outcome Measures
Incidence of adverse events (AEs)
Secondary Outcome Measures
Concentration of NNC0215-0384 in serum
Concentration of NNC0215-0384 in serum
Duration of full and duration of detectable levels of C5a receptor (C5aR) occupancy by NNC0215-0384 on neutrophils from baseline
Change in health assessment questionnaire - disability index (HAQ-DI) from baseline
Incidence and characterisation of antibodies directed against NNC0215-0384 and, if present, their in vitro neutralising activity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01955603
Brief Title
A Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0215-0384 Administered to Subjects With Moderate to Severe Rheumatoid Arthritis
Official Title
A Randomised, Placebo-controlled, Double-blind Within Cohort, Dose Escalation, Multiple-dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0215-0384 Administered Subcutaneously to Subjects With Moderate to Severe Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose level 1
Arm Type
Experimental
Arm Title
Dose level 2
Arm Type
Experimental
Arm Title
Dose level 3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
NNC0215-0384
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo administered corresponding to NNC0215-0384 treatment
Primary Outcome Measure Information:
Title
Incidence of adverse events (AEs)
Time Frame
From first dosing until 19 weeks after first dosing
Secondary Outcome Measure Information:
Title
Concentration of NNC0215-0384 in serum
Time Frame
7 days after each dose
Title
Concentration of NNC0215-0384 in serum
Time Frame
3 days after first and last dose
Title
Duration of full and duration of detectable levels of C5a receptor (C5aR) occupancy by NNC0215-0384 on neutrophils from baseline
Time Frame
From week 0 until 19 weeks after first dosing
Title
Change in health assessment questionnaire - disability index (HAQ-DI) from baseline
Time Frame
Week 0, week 7 first dosing
Title
Incidence and characterisation of antibodies directed against NNC0215-0384 and, if present, their in vitro neutralising activity
Time Frame
From first dosing until 19 weeks after first dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
City
Berlin
ZIP/Postal Code
13353
Country
Germany
City
Budapest
ZIP/Postal Code
H1027
Country
Hungary
City
Krakow
ZIP/Postal Code
31-637
Country
Poland
City
Moscow
ZIP/Postal Code
119435
Country
Russian Federation
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
A Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0215-0384 Administered to Subjects With Moderate to Severe Rheumatoid Arthritis
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