Chinese SLE Treatment And Research Group — Biomedical Watch V2

Traitements3programmes

Essais1liés

Publications2liées

SourceDBlocale

Traitements

3

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
Ivarmacitinib Sulfate TabletsThis randomized, double-blind, parallel-group, noninferiority clinical trial will evaluate the efficacy and safety of ivarmacitinib compared with oral prednisone in participants with mild-to-moderate active systemic lupus erythematosus (SLE) without active major organ involvement. Approximately 294 participants will be randomized in a 1:1 ratio to receive either ivarmacitinib 8 mg once daily or oral prednisone starting at 30 mg/day with a prespecified tapering schedule, together with the corresponding matching placebo, for 24 weeks. The study will assess whether ivarmacitinib is noninferior to oral prednisone in achieving the primary efficacy outcome. The primary outcome is the proportion of participants achieving remission of arthritis and/or rash, as defined by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), at Week 12. Safety and secondary efficacy outcomes will be evaluated throughout the 24-week treatment period.	Lupus	Phase 2/3	À vérifier	China	À vérifier
Prednisone Acetate TabletsThis randomized, double-blind, parallel-group, noninferiority clinical trial will evaluate the efficacy and safety of ivarmacitinib compared with oral prednisone in participants with mild-to-moderate active systemic lupus erythematosus (SLE) without active major organ involvement. Approximately 294 participants will be randomized in a 1:1 ratio to receive either ivarmacitinib 8 mg once daily or oral prednisone starting at 30 mg/day with a prespecified tapering schedule, together with the corresponding matching placebo, for 24 weeks. The study will assess whether ivarmacitinib is noninferior to oral prednisone in achieving the primary efficacy outcome. The primary outcome is the proportion of participants achieving remission of arthritis and/or rash, as defined by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), at Week 12. Safety and secondary efficacy outcomes will be evaluated throughout the 24-week treatment period.	Lupus	Phase 2/3	À vérifier	China	À vérifier
Ivarmacitinib Sulfate TabletsThis randomized, double-blind, parallel-group, noninferiority clinical trial will evaluate the efficacy and safety of ivarmacitinib compared with oral prednisone in participants with mild-to-moderate active systemic lupus erythematosus (SLE) without active major organ involvement. Approximately 294 participants will be randomized in a 1:1 ratio to receive either ivarmacitinib 8 mg once daily or oral prednisone starting at 30 mg/day with a prespecified tapering schedule, together with the corresponding matching placebo, for 24 weeks. The study will assess whether ivarmacitinib is noninferior to oral prednisone in achieving the primary efficacy outcome. The primary outcome is the proportion of participants achieving remission of arthritis and/or rash, as defined by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), at Week 12. Safety and secondary efficacy outcomes will be evaluated throughout the 24-week treatment period.	Lupus	Phase 2/3	À vérifier	China	À vérifier

Essais cliniques

1

Molécule	Indication / population	Phase	NCT	Titre	Statut
Ivarmacitinib Sulfate Tablets	Lupus	Phase 2/3	NCT07814664	Ivarmacitinib Versus Glucocorticoids in Mild-to-Moderate Systemic Lupus Erythematosus	NOT_YET_RECRUITING

Publications

2

Molécule	Indication / population	Titre	Journal	Date
Ivarmacitinib Sulfate Tablets		Quantification of SHR0302 in human plasma by UPLC-MS/MS and application to a pharmacokinetic study.	Biomedical chromatography : BMC
Prednisone Acetate Tablets		['s subcutaneous needling for postauricular pain in the treatment of acute idiopathic facial paralysis: a randomized controlled trial].	Zhongguo zhen jiu = Chinese acupuncture & moxibustion