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

Innate Pharma

Status and phase: Completed; Phase 1

Conditions: Inflammation; Rheumatoid Arthritis

Treatments: Drug: placebo; Drug: NNC 0141-0000-0100

Study type: Interventional

Funder types: Industry

Identifiers

NCT01370902

U1111-1120-2542 (Other Identifier)

2010-019234-28 (EudraCT Number)

NN8765-3658

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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92 participants in 3 patient groups

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

Experimental group

Treatment:

Drug: placebo

Drug: NNC 0141-0000-0100

Drug: placebo

Drug: NNC 0141-0000-0100

Drug: placebo

Drug: NNC 0141-0000-0100

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

Experimental group

Treatment:

Drug: placebo

Drug: NNC 0141-0000-0100

Drug: placebo

Drug: NNC 0141-0000-0100

Drug: placebo

Drug: NNC 0141-0000-0100

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

Experimental group

Treatment:

Drug: placebo

Drug: NNC 0141-0000-0100

Drug: placebo

Drug: NNC 0141-0000-0100

Drug: placebo

Drug: NNC 0141-0000-0100