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Phase 3 Study of MT-0551 in Patients with Systemic Sclerosis (Placebo-Controlled Double-Blind Study)

Phase 3 Study of MT-0551 in Patients with Systemic Sclerosis

Kondou Kazuoki

Tanabe Pharma Corporation

1-1-1, Marunouchi, Chiyoda-ku, Tokyo

cti-inq-ml.JP@ml.tanabe-pharma.com

Information Desk Clinical Trials

Tanabe Pharma Corporation

1-1-1, Marunouchi, Chiyoda-ku, Tokyo

+81-3-5960-9608

cti-inq-ml.JP@ml.tanabe-pharma.com

Not Recruiting

July. 01, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

(1)ACR/European League Against Rheumatism (EULAR) criteria (2013) systemic sclerosis (SSc) diagnostic criteria satisfied.
(2)Skin thickening score based on the mRTSS between 10 and 22 inclusive.

(1)Pulmonary hypertension associated with SSc.
(2)Presence of a serious, SSc-related concurrent illness other than interstitial pneumonia.
(3)Finding of inadequate respiratory reserve capacity.
(4)Past history of rituximab, blinatumomab, obinutuzumab, or ofatumumab.
(5)Presence of a clinically significant active infection requiring antimicrobial therapy.
(6)A past history of cancer.
(7)Past history of a recurrent, clinically significant infection.
(8)Past history of severe allergy or anaphylactic reaction to a biologic drug product.
(9)Treatment with live vaccine within a certain period (inactivated vaccine is acceptable).

Both

Systemic Sclerosis

(1)MT-0551 group
Participants will receive intravenous (IV) inebilizumab on Day 1 and Day 15 of randomized controlled period (RCP). The participants who entered open label period (OLP) will receive IV inebilizumab on Day 1 and IV placebo on Day 15 of OLP and will be followed by IV inebilizumab every 26 weeks.
(2)Placebo group
Participants will receive IV placebo on Day 1 and Day 15 of the RCP. The participants who entered OLP will receive IV inebilizumab on both Day 1 and Day 15 in OLP and will be followed by IV inebilizumab every 26 weeks.

Change from baseline in the mRTSS up to the end of the long-term extension period

(1)Pulmonary function tests: Change and percentage change from baseline in the percent predicted forced vital capacity (%FVC) and percent predicted diffusing capacity of the lung carbon monoxide (%DLco)
(2)Change from baseline in the mRTSS
(3)Composite response index in diffuse cutaneous systemic sclerosis

+81-3-5800-8743

Jan. 07, 2022

No

none