Safety and Tolerability of Anti-IL-20 in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Dose-escalation, Phase 1 Trial of Anti-IL-20 in Subjects With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01038674
• Other study ID #: NN8226-3704
• Secondary ID: 2009-013132-20U1
• Status: Completed
• Phase: Phase 1
• First received: December 22, 2009
• Last updated: February 8, 2017
• Start date: February 2010
• Est. completion date: December 2010

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety and tolerability of the drug Anti-IL-20 in subjects with rheumatoid arthritis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Informed consent obtained before any trial-related activities

• A diagnosis of rheumatoid arthritis made at least 3 months prior to screening

• Active rheumatoid arthritis, characterised by a DAS28 equal or above 3.2

• Methotrexate treatment (stable dose, equal or below 25 mg/week) for at least 4 weeks prior to study start (subjects receiving stable doses of oral corticosteroids, and/or non-steroidal anti-inflammatory drugs and/or acetaminophen and/or opioids according to prescribed recommended doses can be included)

• Male subjects and female subjects of non-child bearing potential

Exclusion Criteria:

• Body mass index (BMI) less than 18.5 or above 35.0 kg/m2

• Subjects with chronic inflammatory autoimmune disease other than rheumatoid arthritis

• History of or current inflammatory joint disease other than rheumatoid arthritis

• Chronic or ongoing infectious disease requiring systemic anti-infectious treatment within 2 weeks prior to study start

• Past or current malignancy (as judged by the investigator)

• Clinically significant cardiac or cardiovascular disease

• Positive for human immunodeficiency virus (HIV), hepatitis or tuberculosis

• Blood donation or blood loss of more than 0.45L within 2 months prior to study start, or longer if required by local regulations

• Breast-feeding women

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Inflammation
• Rheumatoid Arthritis

Intervention

Drug:
• anti-IL-20
Anti-IL-20 injected subcutaneously (under the skin) with 1 dose once weekly during a 6 week period (in total 7 doses) at 2 dose levels.
• placebo
Placebo injected subcutaneously (under the skin) with 1 dose once weekly during a 6 week period (in total 7 doses) at 2 dose levels.

Locations

Country	Name	City	State
Belgium	Novo Nordisk Investigational Site	Brussels
Poland	Novo Nordisk Investigational Site	Warszawa

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Belgium,  Poland, 

References & Publications (1)

Lundblad MS, Overgaard RV, Göthberg M, Fjording MS, Watson E. Clinical pharmacokinetics of the anti-interleukin-20 monoclonal antibody NNC0109-0012 in healthy volunteers and patients with psoriasis or rheumatoid arthritis. Adv Ther. 2015 Mar;32(3):228-38. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events		0 - 21 weeks after dosing
Secondary	Terminal serum half-life		0 - 21 weeks after dosing
Secondary	Maximum observed serum concentration (Cmax)		6 - 10 weeks after dosing
Secondary	Change in ACR20, ACR50 and ACR70		0-21 hours after dosing

External Links

•   Clinical Trials at Novo Nordisk