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

NCT00818064 | Completed Phase 1

• 3 other identifiers: NN8226-37032008-005529-13EudraCT No: 2008-005529-13
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Adverse events, including injection site tolerability

  during treatment

Secondary Outcomes (5)

• Terminal serum half-life (t½)

  during treatment

• Maximum observed serum concentration (Cmax)

  during treatment

• Time to reach maximum serum concentration (tmax)

  during treatment

• Area under the serum concentration-time curve (AUC0-t and AUC)

  during treatment

• Relevant biomarkers in serum and plasma, as well as synovial fluid (if applicable)

  during treatment

Study Arms (8)

A, HV

EXPERIMENTAL

Dose cohort 1 (3 subjects active, 1 placebo)

Drug: anti-IL-20; Drug: placebo

B, HV

EXPERIMENTAL

Dose cohort 2 (3 subjects active, 1 placebo)

Drug: anti-IL-20; Drug: placebo

C, HV

EXPERIMENTAL

Dose cohort 3 (3 subjects active, 1 placebo)

Drug: anti-IL-20; Drug: placebo

D, HV

EXPERIMENTAL

Dose cohort 4 (3 subjects active, 1 placebo)

Drug: anti-IL-20; Drug: placebo

E, HV

EXPERIMENTAL

Dose cohort 5 (3 subjects active, 1 placebo)

Drug: anti-IL-20; Drug: placebo

A, RA

EXPERIMENTAL

Dose cohort 1 (3 subjects active, 1 placebo)

Drug: anti-IL-20; Drug: placebo

B, RA

EXPERIMENTAL

Dose cohort 2 (3 subjects active, 1 placebo)

Drug: anti-IL-20; Drug: placebo

C, RA

EXPERIMENTAL

Dose cohort 3 (3 subjects active, 1 placebo)

Drug: anti-IL-20; Drug: placebo

Interventions

anti-IL-20 DRUG

Single s.c. injection (per dose cohort)

Also known as: NN8226

A, HV; A, RA; B, HV; B, RA; C, HV; C, RA; D, HV; E, HV

placebo DRUG

Single s.c. injection (per dose cohort)

Also known as: NN8226

A, HV; A, RA; B, HV; B, RA; C, HV; C, RA; D, HV; E, HV

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Groningen, 9728 NZ, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 25749867 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Inflammation; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2008
• First Posted: January 7, 2009
• Study Start: December 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: February 9, 2017

Record last verified: 2017-02

Locations

NL (1)