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

Primary Purpose

Inflammation, Rheumatoid Arthritis

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

NNC 0141-0000-0100

placebo

NNC 0141-0000-0100

placebo

NNC 0141-0000-0100

placebo

About this trial

This is an interventional treatment trial for Inflammation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Single-dose (SD) trial part (i.v.)

Single-dose (SD) trial part (s.c.)

Multiple-dose (MD) trial part (s.c.)

Arm Description

Outcomes

Primary Outcome Measures

Incidence of adverse events

Secondary Outcome Measures

Antibodies against NNC141-0100

Area under the serum concentration-time curve - SD trial part

Terminal half-life (t½) - SD trial part

Terminal half-life (t½) - MD trial part

Full Information

NCT ID

NCT01370902

First Posted

May 31, 2011

Last Updated

December 20, 2014

Sponsor

Innate Pharma

1. Study Identification

Unique Protocol Identification Number

NCT01370902

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Innate Pharma

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammation, Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

92 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single-dose (SD) trial part (i.v.)

Arm Type

Experimental

Arm Title

Single-dose (SD) trial part (s.c.)

Arm Type

Experimental

Arm Title

Multiple-dose (MD) trial part (s.c.)

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

NNC 0141-0000-0100

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Single dose administered subcutaneously (under the skin) as a comparator at all dose levels

Intervention Type

Drug

Intervention Name(s)

NNC 0141-0000-0100

Intervention Description

Multiple doses administered subcutaneously (under the skin) at 4 different occasions with a dosing interval of two weeks, at five different dose levels.

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Multiple doses administered subcutaneously (under the skin) as a comparator at all dose levels

Intervention Type

Drug

Intervention Name(s)

NNC 0141-0000-0100

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Single dose administered intravenously (into a vein), as a comparator at all dose levels

Primary Outcome Measure Information:

Title

Incidence of adverse events

Time Frame

from trial product administration to week 12

Secondary Outcome Measure Information:

Title

Antibodies against NNC141-0100

Time Frame

from trial product administration until final visit (week 12 or longer if applicable)

Title

Area under the serum concentration-time curve - SD trial part

Time Frame

from trial product administration until final visit (week 12 or longer if applicable)

Title

Terminal half-life (t½) - SD trial part

Time Frame

from trial product administration until final visit (week 12 or longer if applicable)

Title

Terminal half-life (t½) - MD trial part

Time Frame

from trial product administration until final visit (week 12 or longer if applicable)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Renaud Buffet

Organizational Affiliation

Innate Pharma

Official's Role

Study Director

Facility Information:

City

Berlin

ZIP/Postal Code

13353

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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