A Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0215-0384 Administered to Subjects With Moderate to Severe Rheumatoid Arthritis

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01955603
• Collaborator: (none)
• Enrollment: 24
• Locations: 4
• Arms: 3
• Duration (Months): 13
• Patients Per Site: 6
• Patients Per Site Per Month: 0.5

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Inflammation; Rheumatoid Arthritis	Drug: NNC0215-0384; Drug: placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: Sep 1, 2013
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose level 1	Drug: NNC0215-0384; 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.; Drug: placebo; Placebo administered corresponding to NNC0215-0384 treatment
Experimental: Dose level 2	Drug: NNC0215-0384; 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.; Drug: placebo; Placebo administered corresponding to NNC0215-0384 treatment
Experimental: Dose level 3	Drug: NNC0215-0384; 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.; Drug: placebo; Placebo administered corresponding to NNC0215-0384 treatment

Outcome Measures

Primary Outcome Measures

1. Incidence of adverse events (AEs) [From first dosing until 19 weeks after first dosing]

Secondary Outcome Measures

1. Concentration of NNC0215-0384 in serum [7 days after each dose]

2. Concentration of NNC0215-0384 in serum [3 days after first and last dose]

3. 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]

4. Change in health assessment questionnaire - disability index (HAQ-DI) from baseline [Week 0, week 7 first dosing]

5. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Berlin		Germany	13353
2		Budapest		Hungary	H1027
3		Krakow		Poland	31-637
4		Moscow		Russian Federation	119435

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT01955603
• Other Study ID Numbers: NN8210-3927; 2012-003969-18; U1111-1133-7983
• First Posted: Oct 7, 2013
• Last Update Posted: Oct 15, 2014
• Last Verified: Oct 1, 2014

• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Inflammation

Study Results

No Results Posted as of Oct 15, 2014