Safety and Tolerability of NNC0114-0006 at Increasing Dose Levels in Subjects With Rheumatoid Arthritis

Novo Nordisk A/S32 enrolled

Overview

This trial is conducted in Europe. The aim of this dose-escalating trial is to assess the safety and tolerability of multiple doses of NNC0114-0006 in subjects with rheumatoid arthritis (RA).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Inflammation Rheumatoid Arthritis

Interventions

NNC0114-0006DRUG

Multiple subcutaneous (s.c., under the skin) doses administered every second week for six weeks. The trial comprises dose escalation up to four dose levels. Progression to next dose will be based on safety evaluation.

placeboDRUG

Multiple subcutaneous (s.c., under the skin) doses administered every second week for six weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * A diagnosis of RA, meeting the 2010 ACR-EULAR (American College of Rheumatology-European League Against Rheumatism) or the 1987 ACR classification criteria, made at least 4 months prior to trial drug administration * Active RA, characterised by a DAS28-CRP equal to or above 4.5 and at least 5 tender and 5 swollen joints * Methotrexate (MTX) treatment for at least 16 weeks (dose equal to or above 7.5 mg/week and equal to or below 25 mg/week) at a stable dose for at least 6 weeks prior to dosing * Female subjects not pregnant and not nursing Exclusion Criteria: * Subjects with chronic inflammatory autoimmune disease other than RA * Any active or ongoing chronic infectious disease requiring systemic anti-infectious treatment within 4 weeks prior to randomisation * Body mass index (BMI) below 18.0 or above 35.0 kg/m\^2

Locations (5)

Novo Nordisk Investigational Site

Berlin, Germany

Novo Nordisk Investigational Site

Moscow, Russia

Novo Nordisk Investigational Site

Moscow, Russia

Novo Nordisk Investigational Site

Moscow, Russia

Outcomes

Primary Outcomes

Incidence of adverse events (AEs)

Time frame: From first administration of trial product (week 1) and up until week 27

Secondary Outcomes

Change in serum levels of total IL-21 from first administration of trial product

Time frame: Week 1, week 27

Change in disease activity score 28 calculated using C-reactive protein (DAS28-CRP)

Time frame: From week 1 to week 9 (8 weeks after initiation of treatment)

Data from ClinicalTrials.gov

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