A Trial Investigating the Mechanism of Action of NNC0109-0012 (Anti-IL-20 mAb) Through Synovial Biopsies in Subjects With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Rheumatoid Arthritis Clinical Trial

Official title:

A Randomised, Active Comparator, Double-blind, Multi Centre, Parallel, Phase 2a Trial, Investigating the Mechanism of Action, of NNC0109-0012 (Anti-IL-20 mAb) Through Synovial Biopsies in Subjects With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02097264
• Other study ID #: NN8226-4064
• Secondary ID: 2013-001492-20U1
• Status: Withdrawn
• Phase: Phase 2
• First received: March 24, 2014
• Last updated: August 13, 2014
• Start date: September 2014
• Est. completion date: September 2015

Study information

• Verified date: August 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Irish Medicines BoardPortugal: National Pharmacy and Medicines InstituteSpain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Europe. The aim of the trial is to investigate the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis (RA) and an inadequate response to Methotrexate.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male or female age at least 18 and below or equal to 75 years at the time of signing informed consent

• A diagnosis of RA at least 6 months prior to screening visit, according to the American College of Rheumatology (EULAR/ACR 2010 criteria) or by standard criteria (ACR 1987) if diagnosis was made earlier than 2010

• Subjects with ACR global functional status of 1 to 3

• Active RA, characterised by: DAS28 (Disease Activity Score 28) (CRP (C-reactive protein)) above 4.5 and equal to or above 6 tender and equal to or above 6 swollen joints based on a 66/68 joint count

• Active Synovitis in at least two joints of the wrist and metacarpophalangeal joints, as assessed by high frequency Power Doppler ultrasound scan at screening and randomisation

Exclusion Criteria:

• Subjects with arthritis due to other autoimmune diseases than RA

• Body weight above 90.0 kg

• History of or current inflammatory joint disease other than RA (e.g. gout, psoriatic or reactive arthritis, Lyme disease, juvenile idiopathic arthritis, excluding secondary Sjogren syndrome and hypothyroidism)

• Any active or on-going bacterial infections within 4 weeks prior to screening visit, unless treated and resolved with appropriate therapy or any history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis)

• Subjects with malignancy within the previous 5 years with the exception of adequately treated and cured basal or squamous cell carcinoma of the skin or cervical carcinoma in situ occurring more than 12 months prior to screening visit

• Female who is pregnant, breast feeding, intends to become pregnant or is of childbearing potential, not willing to use two highly effective contraceptive methods (adequate highlyeffective contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system) one of which has to be a barrier method a barrier method of contraception (e.g. condom with spermicidal foam/gel/film/cream), for at least 16 weeks (approximately 5 half-lives) following the last dose of trial medication

• Male subjects who are sexually active and not surgically sterilised, who or whose partner are unwilling to use two different forms of highly effective contraception, one of which has to be a barrier method a barrier method of contraception (e.g. condom with spermicidal foam/gel/film/cream) for the duration of the trial and for at least 16 weeks (approximately 5 half-lives) following the last dose of trial medication

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Inflammation
• Rheumatoid Arthritis

Intervention

Drug:
• NNC0109-0012
Solution for injection administered subcutaneously (s.c. - under the skin). 240 mg NNC0109-0012 will be administered weekly for 12 weeks
• Adalimumab
Solution for injection administered subcutaneously (s.c. - under the skin). Administered every other week for 12 weeks; Each active treatment involves 1 (one) s.c. injection of adalimumab 40 mg/0,8 mL solution for injection for paediatric use (Humira®)
• placebo
Solution for injection administered subcutaneously (s.c. - under the skin). 1 active adalimumab injection and 2 placebo injections per active treatment (every other week), and 3 placebo injections on placebo visits (alternative weeks).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the total histopathological synovitis score		Week 0, week 12	No
Secondary	Change in dynamic contrast enhanced MRI (DCE-MRI) measures of initial rate of enhancement (IRE)		Week 0, week 12	No
Secondary	Change in dynamic contrast enhanced MRI (DCE-MRI) measures of maximal enhancement (ME)		Week 0, week 12	No
Secondary	Changes in RA-MRI scores (RAMRIS (Rheumatoid arthritis magnetic resonance imaging)) of synovitis		Week 0, week 12	No
Secondary	Changes in RA-MRI scores (RAMRIS) of oedema		Week 0, week 12	No
Secondary	Changes in RA-MRI scores (RAMRIS) of erosion		Week 0, week 12	No
Secondary	Change in high frequency ultrasound with Power Doppler measures of total synovitis		Week 0, week 12	No
Secondary	Change in high frequency ultrasound with Power Doppler measures of total tenosynovitis scores		Week 0, week 12	No
Secondary	Change in disease activity 28 - C-reactive protein (DAS28 (CRP)		Week 0, week 12	No
Secondary	Incidence of Adverse Events (AE)		Week 0, week 24	No
Secondary	Incidence of local intolerability at the injection site		Week 0, week 24	No

External Links

•   Clinical Trials at Novo Nordisk