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

Safety and Tolerability of NNC0114-0006 Following Multiple s.c. Dosing at Escalating Dose Levels in Subjects With Rheumatoid Arthritis

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01565408

Enrollment

Registered

2012-03-28

Start date

2012-03-31

Completion date

2013-10-31

Last updated

2017-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation, Rheumatoid Arthritis

Brief summary

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).

Interventions

DRUGNNC0114-0006

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.

DRUGplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events (AEs)	From first administration of trial product (week 1) and up until week 27

Secondary

Measure	Time frame
Change in serum levels of total IL-21 from first administration of trial product	Week 1, week 27
Change in disease activity score 28 calculated using C-reactive protein (DAS28-CRP)	From week 1 to week 9 (8 weeks after initiation of treatment)

Countries

Germany, Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026