A MULTICENTER, PLACEBO-CONTROLLED, RANDOMIZED, DOUBLE-BLIND PHASE III CLINICAL TRIAL OF OBINUTUZUMAB IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS

JRCT ID: jRCT2071230031

Registered date:25/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: systemic lupus erythematosus
• Date of first enrollment: 10/10/2023
• Target sample size: 24
• Study type: Interventional
• Intervention(s): obinutuzumab: Intravenous infusion of 1000 mg of obinutuzumab (genetical recombination) at a time.

Outcome(s)

Primary Outcome

efficacy
To evaluate the efficacy of obinutuzumab when combined with standard-of-care therapy (the proportion of participants who achieve SRI(4) at Week 52). SRI(4) is defined as achievement of all of the following:
-Reduction from baseline of >4 points in the SLEDAI-2K
-No new systems or organs affected, as defined by >1 new BILAG A or >2 new BILAG B items compared with baseline using BILAG-2004
-No worsening from baseline of >0.3 points on a 3-point PGA-VAS

Secondary Outcome

safety,efficacy,phamacokinetics,phamacodynamics,other
To evaluate the efficacy of obinutuzumab when combined with standard-of-care therapy(i.e., the secondary endpoints).
The main secondary endpoints are
-Proportion of participants who achieve BICLA at Week 52
-Proportion of participants who achieve LLDAS at Week 52
-Proportion of participants who achieve SRI(6) at Week 52

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

(1)Patients living in Japan aged 18-75 years
(2)Diagnosis of SLE according to the 2019 EULAR/ACR Classification Criteria >12 weeks prior to screening
(3)ANA >1:80, or anti-dsDNA and/or anti-Sm antibodies above the upper limit of normal (ULN)
(4)Low C3 and/or low C4 and/or low CH50 complement
(5)High disease activity at screening, as defined by all of the following:
-BILAG-2004: Category A disease in >1 organ system and/or Category B disease in >2 organ systems
-SLEDAI-2K: score >8
-Physician`s Global Assessment (PGA): score >1.0 on a 0 to 3 Visual Analog Scale (VAS)
(6)Current receipt of >1 of the following classes of standard therapies for the treatment of SLE at stable doses: OCS, antimalarials, conventional immunosuppressants

Exclude criteria

(1)Presence of significant lupus-associated renal disease and/or renal impairment
(2)Active severe or unstable lupus-associated neuropsychiatric disease
(3)Receipt of any of the following excluded therapies:
-Any B-cell depleting (e.g., anti-CD20, anti-CD19) or anti-plasma cell therapy such as, but not limited to, obinutuzumab, rituximab, ofatumumab, or bortezomib less than 9 months prior to Day1
-Cyclophosphamide less than 3 months prior to Day1
-Calcineurin inhibitor (ciclosporin, voclosporin) less than 4 weeks prior to Day1
-Any biologic therapy (drugs other than B cell or plasma cell depleting drugs that may affect the safety of subjects or evaluation of this study) such as, but not limited to, belimumab, ustekinumab, anifrolumab, secukinumab, or atacicept less than 2 months prior to Day1
-Any live vaccine less than 28 days prior to Day1

Related Information

• Primary Sponsor: Yoshiya Tanaka