Safety and Tolerability of Anti-IL-20 in Healthy Volunteers and Patients With Rheumatoid Arthritis

NCT ID: NCT00818064

Last Updated: 2017-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2010-01-31

Brief Summary

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety and tolerability of single doses of Anti-IL-20 in healthy volunteers (HV) and patients with rheumatoid arthritis (RA).

Conditions

Inflammation; Rheumatoid Arthritis; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A, HV

Dose cohort 1 (3 subjects active, 1 placebo)

Group Type: EXPERIMENTAL

anti-IL-20

Intervention Type: DRUG

Single s.c. injection (per dose cohort)

placebo

Intervention Type: DRUG

Single s.c. injection (per dose cohort)

B, HV

Dose cohort 2 (3 subjects active, 1 placebo)

Group Type: EXPERIMENTAL

anti-IL-20

Intervention Type: DRUG

Single s.c. injection (per dose cohort)

placebo

Intervention Type: DRUG

Single s.c. injection (per dose cohort)

C, HV

Dose cohort 3 (3 subjects active, 1 placebo)

Group Type: EXPERIMENTAL

anti-IL-20

Intervention Type: DRUG

Single s.c. injection (per dose cohort)

placebo

Intervention Type: DRUG

Single s.c. injection (per dose cohort)

D, HV

Dose cohort 4 (3 subjects active, 1 placebo)

Group Type: EXPERIMENTAL

anti-IL-20

Intervention Type: DRUG

Single s.c. injection (per dose cohort)

placebo

Intervention Type: DRUG

Single s.c. injection (per dose cohort)

E, HV

Dose cohort 5 (3 subjects active, 1 placebo)

Group Type: EXPERIMENTAL

anti-IL-20

Intervention Type: DRUG

Single s.c. injection (per dose cohort)

placebo

Intervention Type: DRUG

Single s.c. injection (per dose cohort)

A, RA

Dose cohort 1 (3 subjects active, 1 placebo)

Group Type: EXPERIMENTAL

anti-IL-20

Intervention Type: DRUG

Single s.c. injection (per dose cohort)

placebo

Intervention Type: DRUG

Single s.c. injection (per dose cohort)

B, RA

Dose cohort 2 (3 subjects active, 1 placebo)

Group Type: EXPERIMENTAL

anti-IL-20

Intervention Type: DRUG

Single s.c. injection (per dose cohort)

placebo

Intervention Type: DRUG

Single s.c. injection (per dose cohort)

C, RA

Dose cohort 3 (3 subjects active, 1 placebo)

Group Type: EXPERIMENTAL

anti-IL-20

Intervention Type: DRUG

Single s.c. injection (per dose cohort)

placebo

Intervention Type: DRUG

Single s.c. injection (per dose cohort)

Interventions

anti-IL-20

Single s.c. injection (per dose cohort)

Intervention Type: DRUG

placebo

Single s.c. injection (per dose cohort)

Intervention Type: DRUG

Other Intervention Names

NN8226; NN8226

Eligibility Criteria

Inclusion Criteria

• For healthy volunteers (HV) the following applies:
• Subjects who are considered to be generally healthy based on assessment of medical history, physical examination and clinical laboratory data at screening, as judged by the Investigator
• Females who are post-menopausal, surgically sterile or of non-child-bearing potential
• For rheumatoid arthritis (RA) patients the following applies:
• A diagnosis of rheumatoid arthritis according to the American College of Rheumatology (ACR1987 classification) of at least three months' duration prior to dosing
• Active RA, characterised by a Disease Activity Score 28 (DAS28) greater than 3.2
• Methotrexate treatment (stable doses of maximally 25.0 mg/week for at least 4 weeks) and concomitant intake of folic acid 1 mg/day or 5 mg/week
• Females who are post-menopausal, surgically sterile or of non-child-bearing potential

Exclusion Criteria

• For healthy volunteers (HV) the following applies:
• Male subjects who do not accept to use double barrier methods of birth control from first dosing until 3 moths after their last visit
• Body mass index (BMI) below 18.5 or above 35.0 kg/m2
• Clinically significant cardiac or cardiovascular disease
• Abnormal blood pressure and heart rate
• Hepatic insufficiency
• Renal insufficiency
• Positive for humane immunodeficiency virus (HIV)
• Positive for hepatitis B (HBV) or hepatitis C (HCV)
• Lymphoproliferative disease
• History or signs of malignancy (except adequately treated and cured basal or squamous cell carcinoma of the skin or cervical carcinoma in situ occurring more than 12 months prior to dosing)
• History of any autoimmune or current inflammatory conditions including rheumatoid arthritis or any other joint disease
• Active or latent tuberculosis: For tuberculosis unvaccinated subjects detected as a positive Mantoux test. For subjects vaccinated against tuberculosis detected as a positive QuantiFeron-test
• Chronic or ongoing infectious disease requiring systemic anti-infectious treatment within the last 2 weeks prior to administration of trial drug
• Any vaccination within the last month before dosing
• Known active viral, bacterial or fungal infection, including herpes, herpes zoster or cold sores 14 days prior to dosing
• Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 2 weeks prior to dosing, unless in the opinion of the Investigator the medication will not interfere with the trial procedures or compromise the safety of the subject
• History of or current drug and/or alcohol abuse
• Blood donation within the last 3 months (more than 0.45 L)
• For rheumatoid arthritis (RA) patients the following applies:
• Male subjects who do not accept to use double barrier methods of birth control from first dosing until 3 months after their last visit
• Body mass index (BMI) below 18.5 or above 35.0 kg/m2
• Subjects with chronic inflammatory autoimmune disease other than rheumatoid arthritis (except secondary Sjögren's syndrome)
• History of or current inflammatory joint disease other than rheumatoid arthritis (e.g. gout, psoriatic or reactive arthritis, Lyme's disease, juvenile arthritis)
• Chronic or ongoing infectious disease requiring systemic anti-infectious treatment within the last 2 weeks prior to dosing
• Any vaccination within the last month before dosing
• Known active viral, bacterial or fungal infection, including herpes, herpes zoster or cold sores 14 days prior to administration of trial product
• Lymphoproliferative disease
• History or signs of malignancy (except adequately treated and cured basal or squamous cell carcinoma of the skin or cervical carcinoma in situ occurring more than 12 months prior to dosing)
• Use of selective cyclooxygenase-2 (COX-2) inhibitors within the last 2 weeks prior to randomisation
• Concomitant medication

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Groningen, , Netherlands

Countries

Netherlands

References

Lundblad MS, Overgaard RV, Gothberg 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. doi: 10.1007/s12325-015-0191-7. Epub 2015 Mar 7.

Reference Type: RESULT

PMID: 25749867 (View on PubMed)

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

2008-005529-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EudraCT No: 2008-005529-13

Identifier Type: -

Identifier Source: secondary_id

NN8226-3703

Identifier Type: -

Identifier Source: org_study_id