4SC Trials - LARVOL Sigma

Trial + Data / Events

Status

Region

Interventions

Sponsor

Conditions

Primary compl

Study compl

Kinselby (resminostat) / 4SC, Yakult Honsha

RITA, NCT04525729: Rituximab and RASi in Patients With IgAN

Recruiting

116

RoW

Rituximab, HLX01, RAS 2410, No specific restrictions

CHENNAN, Dongfang Hospital Affiliated to Tongji University, Shanghai Pudong New Area People's Hospital, Ruijin Hospital North Shanghai Jiao Tong University School of Medicine, Ningbo Municipal Yinzhou District No.2 Hospital, Third Affiliated Hospital, Sun Yat-Sen University, Xiamen Hongai Hospital, Sir Run Run Shaw Hospital

IgA Nephropathy

07/23

12/23

RESMAIN, NCT02953301 / 2016-000807-99: Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS)

Completed

201

Europe, Japan

resminostat, 4SC-201, Placebo

4SC AG

Mycosis Fungoides, Sezary Syndrome, Lymphoma, T-Cell, Cutaneous

03/23

08/24

vidofludimus (IMU-838) / Immunic

2021-000028-36: Not applicable

Not yet recruiting

1050

Europe, RoW

vidofludimus calcium, Vidofludimus calcium, IMU-838, Tablet

Immunic AG, Immunic AG

Relapsing Multiple Sclerosis, Multiple Sclerosis, Diseases [C] - Nervous System Diseases [C10]

2021-000029-28: Not applicable

Not yet recruiting

1050

Europe

vidofludimus calcium, Vidofludimus calcium, IMU-838, Tablet

Immunic AG, Immunic AG

Relapsing Multiple Sclerosis, Multiple Sclerosis, Diseases [C] - Nervous System Diseases [C10]

ENSURE-1, NCT05134441: Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis

Recruiting

1050

Europe, US, RoW

IMU-838 tablets, vidofludimus calcium, Placebo matching IMU-838 tablets, Placebo matching vidofludimus calcium

Immunic AG

Multiple Sclerosis

09/24

09/32

ENSURE-2, NCT05201638: Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis

Recruiting

1050

Europe, US, RoW

IMU-838 tablets, Vidofludimus calcium, Placebo matching IMU-838 tablets, Placebo matching vidofludimus calcium

Immunic AG

Multiple Sclerosis, Relapsing-Remitting

10/24

10/32

2018-001895-39: A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s disease

Ongoing

258

RoW, Europe

vidofludimus calcium, IMU-838, Tablet

Immunic AG, Immunic AG

Crohn’s disease (CD), Crohn’s disease (CD), Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

EMPhASIS, NCT03846219 / 2018-001896-19: MRI Trial to exPlore the efficAcy and Safety of IMU-838 in Relapsing Remitting Multiple Sclerosis

Active, not recruiting

210

Europe, RoW

IMU-838 (30 mg/day), Vidofludimus Calcium, Oral Tablet (30 mg/day), IMU-838 (45 mg/day), Vidofludimus Calcium, Oral Tablet (45 mg/day), Placebo, IMU-838 (10 mg/day), Vidofludimus Calcium, Oral Tablet (10 mg/day)

Immunic AG

Relapsing-Remitting Multiple Sclerosis (RRMS)

04/20

12/29

IONIC, NCT04516915 / 2020-001805-21: IMU-838 and Oseltamivir in the Treatment of COVID-19

Completed

Europe

IMU-838, Intervention Arm, Oseltamivir, Control arm

University Hospitals Coventry and Warwickshire NHS Trust, Immunic AG, University of Warwick, MODEPHARMA

Covid 19

05/22

09/22

CALDOSE-1, NCT03341962 / 2017-003703-22: Phase 2 Dose-finding IMU-838 for Ulcerative Colitis

Oct 2021 - Dec 2021 : Top-line data from CALDOSE-1 study in moderate-to-severe ulcerative colitis

Terminated

263

Europe, US, RoW

IMU-838, IM90838, vidofludimus calcium, Placebo, Placebo (for IMU-838)

Immunic AG

Ulcerative Colitis

11/22

CALLIPER, NCT05054140 / 2021-000048-23: Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis

Active, not recruiting

450

Europe, Canada, US, RoW

IMU-838, Vidofludimus calcium, Placebo matching IMU-838, Placebo Arm

Immunic AG

Multiple Sclerosis

01/25

domatinostat (4SC-202) / 4SC

2017-001770-42: EMERGE is a trial to investigate whether combining the histone deacetylase inhibitor (HDAC inhibitor) drug 4SC-202 with the immunotherapy drug avelumab is safe and improves outcomes for patients with previously treated gastroesophageal or colorectal cancer

Not yet recruiting

Europe

Domatinostat, Bavencio, Domatinostat, Tablet, Concentrate for solution for infusion, Bavencio

The Royal Marsden NHS Foundation Trust

Advanced gastrooesophageal and colorectal cancer, Gastric, oesophageal and bowel cancer which cannot be cured by surgery and which has been treated before with chemotherapy, Diseases [C] - Cancer [C04]

2018-004788-30: The purpose of the research study is to determine if domatinostat in combination with avelumab will be able to delay or prevent worsening of the disease in patients with advanced unresectable/metastatic Merkel Cell Carcinoma that is continuing to grow after previous anti-PD-(L)1 antibody therapy. Furthermore, safety of the combination during the study conduct will be assessed.

Not yet recruiting

Europe

Domatinostat, Formulation 01, Avelumab, Domatinostat, Formulation 02, 4SC-202, MSB0010718C, Tablet, Concentrate for solution for infusion

4SC AG, 4SC AG, Merck KgAA, A4SC AG, 4SC AG Fraunhoferstrasse 22 82152 Planegg-Martinsried, Germany

patients with advanced unresectable/metastatic Merkel Cell Carcinoma progressing on anti-PD(L)1 antibody therapy Patienten mit fortgeschrittenem, nicht resezierbaren / metastasierten Merkelzellkarzinom, bei denen unter einer Anti-PD-(L)1-Antikörpertherapie eine Progression aufgetreten ist, Metastatic, unresectable Merkel Cell Carcinoma that continues to grow after trearment with anti-PD-(L)1 antibody therapy, Diseases [C] - Cancer [C04]

2019-003575-19: The purpose of the research study is to determine if domatinostat in combination with avelumab will be safe and effective in the treatment of metastatic Merkel Cell Carcinoma in patients who have not received any treatment of their disease

Not yet recruiting

Europe

Domatinostat, Avelumab, 4SC-202, MSB0010718C, Tablet, Concentrate for solution for infusion

4SC AG, 4SC AG, Merck KgAA

treatment-naïve metastatic Merkel Cell Carcinoma, metastatic Merkel Cell Carinoma in patients who have not received any treatment of their disease, Diseases [C] - Cancer [C04]

MERKLIN 2, NCT04393753: Domatinostat in Combination With Avelumab in Patients With Advanced Merkel Cell Carcinoma Progressing on Anti-PD-(L)1

Completed

Europe

domatinostat in combination with avelumab

4SC AG

Merkel Cell Carcinoma

02/24

DONIMI, NCT04133948: Multicenter Phase 1b Trial Testing the Neoadjuvant Combination of Domatinostat, Nivolumab and Ipilimumab in IFN-gamma Signature-low and IFN-gamma Signature-high RECIST 1.1-measurable Stage III Cutaneous or Unknown Primary Melanoma

Active, not recruiting

1/2

Europe

Domatinostat, Nivolumab, Ipilimumab

The Netherlands Cancer Institute, 4SC

Malignant Melanoma Stage III

01/22

11/24

KIO-101 / Kiora Pharma

NCT05629364: A Multi-Centre, Randomised, Controlled, Masked Phase 2 Study of the Safety and Efficacy of KIO-101 Ophthalmic Solution, Versus Vehicle Control in the Treatment of Dry Eye Disease in Patients With Autoimmune Disease

Terminated

RoW

KIO-101, DHODH inhibitor

Kiora Pharmaceuticals, Inc.

Dry Eye Disease

01/24



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