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

February 8, 2017 updated by: Novo Nordisk A/S

A Randomised, Double-blind, Placebo-controlled, Single- Dose, Dose-escalation Trial of Anti-IL-20 in Healthy Volunteers and Patients With Rheumatoid Arthritis

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9728 NZ
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A, HV
Dose cohort 1 (3 subjects active, 1 placebo)
Drug: anti-IL-20
Single s.c. injection (per dose cohort)
Other Names:
  • NN8226
Drug: placebo
Single s.c. injection (per dose cohort)
Other Names:
  • NN8226
Experimental: B, HV
Dose cohort 2 (3 subjects active, 1 placebo)
Drug: anti-IL-20
Single s.c. injection (per dose cohort)
Other Names:
  • NN8226
Drug: placebo
Single s.c. injection (per dose cohort)
Other Names:
  • NN8226
Experimental: C, HV
Dose cohort 3 (3 subjects active, 1 placebo)
Drug: anti-IL-20
Single s.c. injection (per dose cohort)
Other Names:
  • NN8226
Drug: placebo
Single s.c. injection (per dose cohort)
Other Names:
  • NN8226
Experimental: D, HV
Dose cohort 4 (3 subjects active, 1 placebo)
Drug: anti-IL-20
Single s.c. injection (per dose cohort)
Other Names:
  • NN8226
Drug: placebo
Single s.c. injection (per dose cohort)
Other Names:
  • NN8226
Experimental: E, HV
Dose cohort 5 (3 subjects active, 1 placebo)
Drug: anti-IL-20
Single s.c. injection (per dose cohort)
Other Names:
  • NN8226
Drug: placebo
Single s.c. injection (per dose cohort)
Other Names:
  • NN8226
Experimental: A, RA
Dose cohort 1 (3 subjects active, 1 placebo)
Drug: anti-IL-20
Single s.c. injection (per dose cohort)
Other Names:
  • NN8226
Drug: placebo
Single s.c. injection (per dose cohort)
Other Names:
  • NN8226
Experimental: B, RA
Dose cohort 2 (3 subjects active, 1 placebo)
Drug: anti-IL-20
Single s.c. injection (per dose cohort)
Other Names:
  • NN8226
Drug: placebo
Single s.c. injection (per dose cohort)
Other Names:
  • NN8226
Experimental: C, RA
Dose cohort 3 (3 subjects active, 1 placebo)
Drug: anti-IL-20
Single s.c. injection (per dose cohort)
Other Names:
  • NN8226
Drug: placebo
Single s.c. injection (per dose cohort)
Other Names:
  • NN8226

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events, including injection site tolerability
Time Frame: during treatment
during treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Terminal serum half-life (t½)
Time Frame: during treatment
during treatment
Maximum observed serum concentration (Cmax)
Time Frame: during treatment
during treatment
Time to reach maximum serum concentration (tmax)
Time Frame: during treatment
during treatment
Area under the serum concentration-time curve (AUC0-t and AUC)
Time Frame: during treatment
during treatment
Relevant biomarkers in serum and plasma, as well as synovial fluid (if applicable)
Time Frame: during treatment
during treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

December 30, 2008

First Submitted That Met QC Criteria

January 6, 2009

First Posted (Estimate)

January 7, 2009

Study Record Updates

Last Update Posted (Estimate)

February 9, 2017

Last Update Submitted That Met QC Criteria

February 8, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN8226-3703
  • 2008-005529-13 (EudraCT Number)
  • EudraCT No: 2008-005529-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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