Safety and Tolerability of NNC0141-0000-0100 in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

A Randomised, Double-blind, Placebo-controlled, Single-dose and Multiple-dose, Dose-escalation Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0141-0000-0100 in Subjects With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01370902
• Other study ID #: NN8765-3658
• Secondary ID: 2010-019234-28U1
• Status: Completed
• Phase: Phase 1
• First received: May 31, 2011
• Last updated: December 20, 2014
• Start date: May 2011
• Est. completion date: March 2014

Study information

• Verified date: December 2014
• Source: Innate Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Vaccines and Biomedicines; Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Europe. The aim of this dose-escalating trial is to assess the safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and pharmacodynamics (the effect of the investigated drug on the body) of single and repeated doses of NNC141-0100 in subjects with Rheumatoid Arthritis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• A diagnosis of rheumatoid arthritis (RA) according to the American College of Rheumatology (ACR1987 classification) of at least 3 months duration prior to randomisation

• Active Rheumatoid Arthritis (RA) characterised by a DAS28-CRP (Disease Activity Score of 28 joints, calculated with CRP (C-reactive protein) value) greater than or equal to 3.2

• Females must be post-menopausal or surgically sterile (post-menopausal for at least 1 year) or be willing to use highly effective method of birth control

• Males must be willing to use highly effective contraception

• Subjects on stable doses of methotrexate (7.5 to 25 mg/week, both inclusive) for at least 4 weeks prior to randomisation

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Inflammation
• Rheumatoid Arthritis

Intervention

Drug:
• NNC 0141-0000-0100
Single dose administered subcutaneously (under the skin), up to six dose levels. Progression to next dose will be based on safety evaluation. Initiation of the MD s.c. phase will depend on the results from the SD i.v. cohorts as well as the first two dose cohorts of the SD s.c. part
• placebo
Single dose administered subcutaneously (under the skin) as a comparator at all dose levels
• NNC 0141-0000-0100
Multiple doses administered subcutaneously (under the skin) at 4 different occasions with a dosing interval of two weeks, at five different dose levels.
• placebo
Multiple doses administered subcutaneously (under the skin) as a comparator at all dose levels
• NNC 0141-0000-0100
Single dose administered intravenously (into a vein), up to nine dose levels. Progression to next dose will be based on safety evaluation. Initiation of the SD s.c. phase will depend on the results from the first three dose cohorts of the SD i.v. part
• placebo
Single dose administered intravenously (into a vein), as a comparator at all dose levels

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Innate Pharma

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		from trial product administration to week 12	No
Secondary	Antibodies against NNC141-0100		from trial product administration until final visit (week 12 or longer if applicable)	No
Secondary	Area under the serum concentration-time curve - SD trial part		from trial product administration until final visit (week 12 or longer if applicable)	No
Secondary	Terminal half-life (t½) - SD trial part		from trial product administration until final visit (week 12 or longer if applicable)	No
Secondary	Terminal half-life (t½) - MD trial part		from trial product administration until final visit (week 12 or longer if applicable)	No