Yokohama City University Medical Center Trials

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Primary compl

Study compl

Molad, Yair

TOPAZ-2, NCT04961567 / 2020-005776-35: A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus

Recruiting

540

Europe, Canada, Japan, US, RoW

Litifilimab, BIIB059, Placebo

Biogen

Lupus Erythematosus, Systemic

09/25

03/26

NCT04781543 / 2020-005764-62: A Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis

Jan 2024 - Dec 2024: Data from trial for diffuse cutaneous systemic sclerosis

Active, not recruiting

2/3

301

Europe, Japan, US, RoW

HZN-825 BID, Placebo, HZN-825 QD

Amgen, Horizon Therapeutics USA, Inc

Diffuse Cutaneous Systemic Sclerosis, Sclerosis, Systemic

09/25

Kapandjieva, Nadezhda

TOPAZ-1, NCT04895241 / 2020-005775-12: A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus

	Trial initiation of TOPAZ-1 trial in lupus
	Jun 2021 - Jun 2021: Trial initiation of TOPAZ-1 trial in lupus

Recruiting

540

Europe, US, RoW

Litifilimab, BIIB059, Placebo

Biogen

Lupus Erythematosus, Systemic

09/26

03/27

AMETHYST, NCT05531565 / 2020-000727-40: A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus

Recruiting

2/3

474

Europe, Canada, Japan, US, RoW

Litifilimab, BIIB059, Placebo

Biogen, Biogen Idec Research Limited

Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus

10/26

12/27

WILLOW, NCT05162586 / 2021-004648-27: The Study With M5049 in SLE and CLE (SCLE and/or DLE)

	Oct 2024 - Dec 2024 : Data for SLE
	Jul 2024 - Sep 2024 : Data for CLE

Completed

456

Europe, Japan, US, RoW

Enpatoran low dose, M5049, Enpatoran medium dose, Enpatoran high dose, Placebo

EMD Serono Research & Development Institute, Inc., Merck KGaA, Darmstadt, Germany

Systemic Lupus Erythematosus

11/24

Bohn, Jussara Marilu

	Trial initiation of TOPAZ-1 trial in lupus
	Jun 2021 - Jun 2021: Trial initiation of TOPAZ-1 trial in lupus

Recruiting

540

Europe, US, RoW

Litifilimab, BIIB059, Placebo

Biogen

Lupus Erythematosus, Systemic

09/26

03/27

AMETHYST, NCT05531565 / 2020-000727-40: A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus

Recruiting

2/3

474

Europe, Canada, Japan, US, RoW

Litifilimab, BIIB059, Placebo

Biogen, Biogen Idec Research Limited

Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus

10/26

12/27

WILLOW, NCT05162586 / 2021-004648-27: The Study With M5049 in SLE and CLE (SCLE and/or DLE)

	Oct 2024 - Dec 2024 : Data for SLE
	Jul 2024 - Sep 2024 : Data for CLE

Completed

456

Europe, Japan, US, RoW

Enpatoran low dose, M5049, Enpatoran medium dose, Enpatoran high dose, Placebo

EMD Serono Research & Development Institute, Inc., Merck KGaA, Darmstadt, Germany

Systemic Lupus Erythematosus

11/24

Brezoev, Petyo

AMETHYST, NCT05531565 / 2020-000727-40: A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus

Recruiting

2/3

474

Europe, Canada, Japan, US, RoW

Litifilimab, BIIB059, Placebo

Biogen, Biogen Idec Research Limited

Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus

10/26

12/27

WILLOW, NCT05162586 / 2021-004648-27: The Study With M5049 in SLE and CLE (SCLE and/or DLE)

	Oct 2024 - Dec 2024 : Data for SLE
	Jul 2024 - Sep 2024 : Data for CLE

Completed

456

Europe, Japan, US, RoW

Enpatoran low dose, M5049, Enpatoran medium dose, Enpatoran high dose, Placebo

EMD Serono Research & Development Institute, Inc., Merck KGaA, Darmstadt, Germany

Systemic Lupus Erythematosus

11/24

Allton, Pamela

NCT05251727: Assess Safety and Tolerability of ART-123 + FOLFOX + Bevacizumab in Metastatic Colorectal Cancer Patients

Terminated

Japan, US

thrombomodulin alfa, ART-123, Placebo

Veloxis Pharmaceuticals

Chemotherapy-induced Peripheral Neuropathy

06/24

Cruz, Claudia De La

AMETHYST, NCT05531565 / 2020-000727-40: A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus

Recruiting

2/3

474

Europe, Canada, Japan, US, RoW

Litifilimab, BIIB059, Placebo

Biogen, Biogen Idec Research Limited

Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus

10/26

12/27

WILLOW, NCT05162586 / 2021-004648-27: The Study With M5049 in SLE and CLE (SCLE and/or DLE)

	Oct 2024 - Dec 2024 : Data for SLE
	Jul 2024 - Sep 2024 : Data for CLE

Completed

456

Europe, Japan, US, RoW

Enpatoran low dose, M5049, Enpatoran medium dose, Enpatoran high dose, Placebo

EMD Serono Research & Development Institute, Inc., Merck KGaA, Darmstadt, Germany

Systemic Lupus Erythematosus

11/24

WILLOW LTE, NCT05540327 / 2022-000239-21: The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE

Recruiting

532

Europe, Japan, US, RoW

M5049 low dose, Enpatoran, M5049 medium dose, M5049 high dose, Placebo, M5049 very high dose

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, Merck Healthcare KGaA

Systemic Lupus Erythematosus

04/25

Valenzuela, Fernando

AMETHYST, NCT05531565 / 2020-000727-40: A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus

Recruiting

2/3

474

Europe, Canada, Japan, US, RoW

Litifilimab, BIIB059, Placebo

Biogen, Biogen Idec Research Limited

Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus

10/26

12/27

WILLOW, NCT05162586 / 2021-004648-27: The Study With M5049 in SLE and CLE (SCLE and/or DLE)

	Oct 2024 - Dec 2024 : Data for SLE
	Jul 2024 - Sep 2024 : Data for CLE

Completed

456

Europe, Japan, US, RoW

Enpatoran low dose, M5049, Enpatoran medium dose, Enpatoran high dose, Placebo

EMD Serono Research & Development Institute, Inc., Merck KGaA, Darmstadt, Germany

Systemic Lupus Erythematosus

11/24

WILLOW LTE, NCT05540327 / 2022-000239-21: The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE

Recruiting

532

Europe, Japan, US, RoW

M5049 low dose, Enpatoran, M5049 medium dose, M5049 high dose, Placebo, M5049 very high dose

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, Merck Healthcare KGaA

Systemic Lupus Erythematosus

04/25

Leal, Alvaro Andres San Martin

AMETHYST, NCT05531565 / 2020-000727-40: A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus

Recruiting

2/3

474

Europe, Canada, Japan, US, RoW

Litifilimab, BIIB059, Placebo

Biogen, Biogen Idec Research Limited

Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus

10/26

12/27

Gospodinov, Dimitar

TAK-279-3002, NCT06108544: A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 60 Weeks of Treatment With a Withdrawal and Retreatment Period

Active, not recruiting

1108

Europe, Canada, US, RoW

TAK-279, Placebo, Apremilast

Takeda

Plaque Psoriasis

12/24

11/25

AMETHYST, NCT05531565 / 2020-000727-40: A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus

Recruiting

2/3

474

Europe, Canada, Japan, US, RoW

Litifilimab, BIIB059, Placebo

Biogen, Biogen Idec Research Limited

Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus

10/26

12/27

Calabrese, Renato Eduardo Jimenez

AMETHYST, NCT05531565 / 2020-000727-40: A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus

Recruiting

2/3

474

Europe, Canada, Japan, US, RoW

Litifilimab, BIIB059, Placebo

Biogen, Biogen Idec Research Limited

Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus

10/26

12/27



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