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

JRCT ID: jRCT2031210521

Registered date:26/12/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Systemic Sclerosis
• Date of first enrollment: 20/07/2022
• Target sample size: 80
• Study type: Interventional

Intervention(s)

(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.

Outcome(s)

• Primary Outcome: Change from baseline in the mRTSS at Week 26

Secondary Outcome

(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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

(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.

Exclude criteria

(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).

Related Information

• Primary Sponsor: Kondou Kazuoki
• Secondary ID(s): NCT05198557