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

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

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Rheumatoid Arthritis
• Intervention / Treatment: Drug: NNC 0141-0000-0100; Drug: placebo; Drug: NNC 0141-0000-0100; Drug: placebo; Drug: NNC 0141-0000-0100; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single-dose (SD) trial part (i.v.)	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; Drug: placebo; Single dose administered subcutaneously (under the skin) as a comparator at all dose levels; Drug: 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.; Drug: placebo; Multiple doses administered subcutaneously (under the skin) as a comparator at all dose levels; Drug: 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; Drug: placebo; Single dose administered intravenously (into a vein), as a comparator at all dose levels
Experimental: Single-dose (SD) trial part (s.c.)	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; Drug: placebo; Single dose administered subcutaneously (under the skin) as a comparator at all dose levels; Drug: 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.; Drug: placebo; Multiple doses administered subcutaneously (under the skin) as a comparator at all dose levels; Drug: 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; Drug: placebo; Single dose administered intravenously (into a vein), as a comparator at all dose levels
Experimental: Multiple-dose (MD) trial part (s.c.)	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; Drug: placebo; Single dose administered subcutaneously (under the skin) as a comparator at all dose levels; Drug: 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.; Drug: placebo; Multiple doses administered subcutaneously (under the skin) as a comparator at all dose levels; Drug: 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; Drug: placebo; Single dose administered intravenously (into a vein), as a comparator at all dose levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events	from trial product administration to week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Antibodies against NNC141-0100	from trial product administration until final visit (week 12 or longer if applicable)
Area under the serum concentration-time curve - SD trial part	from trial product administration until final visit (week 12 or longer if applicable)
Terminal half-life (t½) - SD trial part	from trial product administration until final visit (week 12 or longer if applicable)
Terminal half-life (t½) - MD trial part	from trial product administration until final visit (week 12 or longer if applicable)

Collaborators and Investigators

• Sponsor: Innate Pharma
• Investigators: Study Director: Renaud Buffet, Innate Pharma

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: May 31, 2011
• First Submitted That Met QC Criteria: June 9, 2011
• First Posted (Estimate): June 10, 2011

Study Record Updates

• Last Update Posted (Estimate): December 23, 2014
• Last Update Submitted That Met QC Criteria: December 20, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Inflammation
• Other Study ID Numbers: NN8765-3658; 2010-019234-28 (EudraCT Number); U1111-1120-2542 (Other Identifier: WHO)