A randomised, single-dose, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC 0142-0000-0002 in subjects with active rheumatoid arthritis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-019261-28-DE

Enrollment

160

Registered

2010-06-16

Start date

2010-07-26

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Rheumatoid arthritis MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis

Interventions

Product Name: NNC 0142-0000-0002 Product Code: NNC 142-0002 Pharmaceutical Form: Powder and solvent for solution for injection Current Sponsor code: NNC 142-0002 Concentration unit: mg/ml milligram(s)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Men and women (not pregnant and not nursing) of =18 and =75 years of age • Subjects with active RA characterised by a DAS28-CRP =4.5 and at least five tender and five swollen joints (can be the same), including one swollen wrist or at least two ipsilateral metacarpophalangeal (MCP) joints (second to fifth) • Ability to be examined by MRI • Concomitant treatment with MTX (7.5-25 mg/week) for at least 12 weeks, with stable dose for at least 4 weeks prior to dosing with trial product • Having failed no biologic therapies for RA and no more than two non-biologic DMARDs (primary or secondary failures to therapy) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Chronic inflammatory autoimmune disease other than RA • Any ongoing chronic or active infectious disease or microbial infection requiring systemic oral or intravenous treatment against infection within 1 month prior to randomisation • Body mass index (BMI) =18.0 or =40.0 kg/m^2

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the change in disease activity following a single subcutaneous (s.c.) dose of NNC 142-0002 compared to placebo in subjects with active rheumatoid arthritis (RA) on background methotrexate (MTX) therapy, measured 12 weeks after administration. ;Secondary Objective: To assess signs of clinical efficacy as determined by the change in disease activity, clinical responses, imaging and pharmacodynamic (PD) biomarkers. Further, safety, tolerability and quality of life will be assessed and the pharmacokinetics (PK), natural killer group 2 member D (NKG2D) receptor occupancy, and the immunogenicity of NNC 142-0002 will be measured. ;Primary end point(s): The primary endpoint is the change in the disease activity score 28 (DAS28) calculated with the C-reactive protein (CRP) value (i.e., DAS28-CRP), from baseline to Week 12.	—

Measure

Time frame

Main Objective: To evaluate the change in disease activity following a single subcutaneous (s.c.) dose of NNC 142-0002 compared to placebo in subjects with active rheumatoid arthritis (RA) on background methotrexate (MTX) therapy, measured 12 weeks after administration. ;Secondary Objective: To assess signs of clinical efficacy as determined by the change in disease activity, clinical responses, imaging and pharmacodynamic (PD) biomarkers. Further, safety, tolerability and quality of life will be assessed and the pharmacokinetics (PK), natural killer group 2 member D (NKG2D) receptor occupancy, and the immunogenicity of NNC 142-0002 will be measured. ;Primary end point(s): The primary endpoint is the change in the disease activity score 28 (DAS28) calculated with the C-reactive protein (CRP) value (i.e., DAS28-CRP), from baseline to Week 12.

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026