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

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

Yoshiya Tanaka

The University of Occupational and Environmental Health

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo

clinical-trials@chugai-pharm.co.jp

Clinical trials information

Chugai Pharmaceutical Co., Ltd.

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo

+81-120189706

clinical-trials@chugai-pharm.co.jp

Not Recruiting

Aug. 01, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

(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

(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

Both

systemic lupus erythematosus

obinutuzumab: Intravenous infusion of 1000 mg of obinutuzumab (genetical recombination) at a time.

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

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

+81-93-603-1611

May. 09, 2023

Yes

Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).

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