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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00818064
First received: December 30, 2008
Last updated: January 19, 2010
Last verified: January 2010
  Purpose

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).


Condition Intervention Phase
Rheumatoid Arthritis
Inflammation
Healthy
Drug: Anti-IL-20
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, Single- Dose, Dose-escalation Trial of Anti-IL-20 in Healthy Volunteers and Patients With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Adverse events, including injection site tolerability [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Terminal serum half-life (t½) [ Time Frame: during treatment ] [ Designated as safety issue: No ]
  • Maximum observed serum concentration (Cmax) [ Time Frame: during treatment ] [ Designated as safety issue: No ]
  • Time to reach maximum serum concentration (tmax) [ Time Frame: during treatment ] [ Designated as safety issue: No ]
  • Area under the serum concentration-time curve (AUC0-t and AUC) [ Time Frame: during treatment ] [ Designated as safety issue: No ]
  • Relevant biomarkers in serum and plasma, as well as synovial fluid (if applicable) [ Time Frame: during treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: December 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A, HV
Dose cohort 1 (3 subjects active, 1 placebo)
Drug: Anti-IL-20
Single s.c. injection (per dose cohort)
Other Name: NN8226
Drug: placebo
Single s.c. injection (per dose cohort)
Other Name: NN8226
Experimental: B, HV
Dose cohort 2 (3 subjects active, 1 placebo)
Drug: Anti-IL-20
Single s.c. injection (per dose cohort)
Other Name: NN8226
Drug: placebo
Single s.c. injection (per dose cohort)
Other Name: NN8226
Experimental: C, HV
Dose cohort 3 (3 subjects active, 1 placebo)
Drug: Anti-IL-20
Single s.c. injection (per dose cohort)
Other Name: NN8226
Drug: placebo
Single s.c. injection (per dose cohort)
Other Name: NN8226
Experimental: D, HV
Dose cohort 4 (3 subjects active, 1 placebo)
Drug: Anti-IL-20
Single s.c. injection (per dose cohort)
Other Name: NN8226
Drug: placebo
Single s.c. injection (per dose cohort)
Other Name: NN8226
Experimental: E, HV
Dose cohort 5 (3 subjects active, 1 placebo)
Drug: Anti-IL-20
Single s.c. injection (per dose cohort)
Other Name: NN8226
Drug: placebo
Single s.c. injection (per dose cohort)
Other Name: NN8226
Experimental: A, RA
Dose cohort 1 (3 subjects active, 1 placebo)
Drug: Anti-IL-20
Single s.c. injection (per dose cohort)
Other Name: NN8226
Drug: placebo
Single s.c. injection (per dose cohort)
Other Name: NN8226
Experimental: B, RA
Dose cohort 2 (3 subjects active, 1 placebo)
Drug: Anti-IL-20
Single s.c. injection (per dose cohort)
Other Name: NN8226
Drug: placebo
Single s.c. injection (per dose cohort)
Other Name: NN8226
Experimental: C, RA
Dose cohort 3 (3 subjects active, 1 placebo)
Drug: Anti-IL-20
Single s.c. injection (per dose cohort)
Other Name: NN8226
Drug: placebo
Single s.c. injection (per dose cohort)
Other Name: NN8226

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00818064

Locations
Netherlands
Zuidlaren, Netherlands, 9471 GP
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Lene Jensen Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00818064     History of Changes
Other Study ID Numbers: NN8226-3703, EudraCT No: 2008-005529-13
Study First Received: December 30, 2008
Last Updated: January 19, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Inflammation
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014