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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Inflammation, Rheumatoid Arthritis

Intervention / Treatment
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* Drug: NNC 0141-0000-0100
* Drug: placebo
* Drug: NNC 0141-0000-0100
* Drug: placebo
* Drug: NNC 0141-0000-0100
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-dose (SD) trial part (i.v.)<br> | Drug: NNC 0141-0000-0100<br>* 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<br>Drug: placebo<br>* Single dose administered intravenously (into a vein), as a comparator at all dose levels<br>|
| Experimental: Single-dose (SD) trial part (s.c.)<br> | Drug: NNC 0141-0000-0100<br>* 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<br>Drug: placebo<br>* Single dose administered subcutaneously (under the skin) as a comparator at all dose levels<br>|
| Experimental: Multiple-dose (MD) trial part (s.c.)<br> | Drug: NNC 0141-0000-0100<br>* Multiple doses administered subcutaneously (under the skin) at 4 different occasions with a dosing interval of two weeks, at five different dose levels.<br>Drug: placebo<br>* Multiple doses administered subcutaneously (under the skin) as a comparator at all dose levels<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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) |