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

• Sponsor: Innate Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01370902
• Collaborator: (none)
• Enrollment: 92
• Location: 1
• Arms: 3
• Duration (Months): 34
• Patients Per Site Per Month: 2.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammation; Rheumatoid Arthritis	Drug: NNC 0141-0000-0100; Drug: placebo; Drug: NNC 0141-0000-0100; Drug: placebo; Drug: NNC 0141-0000-0100; Drug: placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 92 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: May 1, 2011
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single-dose (SD) trial part (i.v.)	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
Experimental: Multiple-dose (MD) trial part (s.c.)	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

Outcome Measures

Primary Outcome Measures

1. Incidence of adverse events [from trial product administration to week 12]

Secondary Outcome Measures

1. Antibodies against NNC141-0100 [from trial product administration until final visit (week 12 or longer if applicable)]

2. Area under the serum concentration-time curve - SD trial part [from trial product administration until final visit (week 12 or longer if applicable)]

3. Terminal half-life (t½) - SD trial part [from trial product administration until final visit (week 12 or longer if applicable)]

4. Terminal half-life (t½) - MD trial part [from trial product administration until final visit (week 12 or longer if applicable)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Berlin		Germany	13353

Sponsors and Collaborators

• Innate Pharma

Investigators

• Study Director: Renaud Buffet, Innate Pharma

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Innate Pharma
• ClinicalTrials.gov Identifier: NCT01370902
• Other Study ID Numbers: NN8765-3658; 2010-019234-28; U1111-1120-2542
• First Posted: Jun 10, 2011
• Last Update Posted: Dec 23, 2014
• Last Verified: Dec 1, 2014

• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Inflammation

Study Results

No Results Posted as of Dec 23, 2014