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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Adverse events, including injection site tolerability
Time Frame: during treatment
during treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 7, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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