A Trial to Evaluate the Safety and Tolerability of Namilumab (MT203) in Patients With Mild to Moderate Rheumatoid Arthritis (PRIORA)

Takeda

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: namilumab (MT203)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01317797

M1-1188-002-EM

NL33507.058.10 (Registry Identifier)

U1111-1137-3923 (Registry Identifier)

2010-018502-36 (EudraCT Number)

Details and patient eligibility

About

The purpose of this trial is primarily to investigate the safety and tolerability of repeated subcutaneous injections of MT203 in patients with mild to moderate rheumatoid arthritis. Furthermore, the amount of MT203 in the blood will be measured and it will be investigated how the body responds to MT203 treatment and if MT203 is effective in the treatment of rheumatoid arthritis.

Full description

The trial medication will be administered at 2 dose levels as subcutaneous injections. Each patient will receive three injections in total. The trial duration consists of a screening period (28 - 2 days prior to the first injection) and a treatment and observation period (4 months). The trial requires approximately 20 visits at the study site.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Out-patients with active rheumatoid arthritis (RA), according to the ACR 1987 revised criteria, with low to moderate disease activity (DAS28-ESR ≥ 2.6 and ≤ 5.1)
2. Patients must be on stable doses of methotrexate (MTX) ≥ 7.5 and ≤ 25 mg/week for at least 12 weeks before the first injection, with appropriate folic acid supplementation
3. Age ≥ 18 years at Screening
4. Body weight at least 50 kg at Screening; BMI: ≥ 18.0 and ≤ 30.0 kg/m2 at Screening
5. Negative tuberculosis test at Screening
6. Heterosexually active male and female patients of childbearing potential are obliged to follow whatever contraceptive and / or breastfeeding restrictions may be required for their concomitant medication(s), including methotrexate.

In addition, heterosexually active male and female patients of childbearing potential are required to use effective double-method contraception (one hormonal contraceptive or intrauterine device and one other additional contraceptive method) for 1 month before the first administration of the IMP, during the course of the trial, and for 6 month after the last injection of MT203.

No special requirements are made for female patients proven to be post-menopausal (at least 2 years after last menstrual period and FSH ≥ 40IU/L), surgically sterilized or hysterectomized. Likewise no special requirements for heterosexually active male who are surgical sterilized.

Pregnant or lactating female patients have to be excluded.

Exclusion criteria

1. Participation in another clinical trial or previous dosing in this trial
2. Use of specified medications within certain timeframes or use of certain comedications
3. History or presence of specified diseases
4. Drug abuse
5. Certain laboratory parameters outside a specified range
6. Donation of blood
7. Relevant decrease in lung function
8. Infections, frequent or chronic infections, herpes zoster
9. Females: positive pregnancy test
10. Presence of history of tuberculosis
11. History of malignancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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24 participants in 3 patient groups, including a placebo group

Namilumab 150 mg

Experimental group

Description:

Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.

Treatment:

Drug: namilumab (MT203)

Namilumab 300 mg

Experimental group

Description:

Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.

Treatment:

Drug: namilumab (MT203)

Placebo

Placebo Comparator group

Description:

Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.

Treatment:

Drug: Placebo