Military Medical Academy - MHAT - Sofia Trials

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Primary compl

Study compl

Chong, Benjamin F

NCT05531565 / 2020-000727-40: A Study to Assess the Efficacy and Safety of BIIB059 (Litifilimab) in Participants With Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy

Recruiting

2/3

474

Europe, Canada, Japan, US, RoW

BIIB059 (litifilimab), litifilimab, Placebo

Biogen, Biogen Idec Research Limited

Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus

10/26

12/27

Najam, Sabeen

BE-EARLY, NCT06411249: A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE)

Recruiting

350

Europe, Japan, US, RoW

Belimumab (GSK1550188), BEL (BENLYSTA)

GlaxoSmithKline

Systemic Lupus Erythematosus

04/27

05/29

RA-BRANCH, NCT04086745: A Study of Baricitinib in Participants With Rheumatoid Arthritis

Recruiting

1300

Baricitinib, LY3009104, TNF Inhibitor, Etanercept, Adalimumab

Eli Lilly and Company, Incyte Corporation

Rheumatoid Arthritis

12/24

02/26

NCT04314531: Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti-TNF naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2)

Active, not recruiting

292

Europe, Japan, US, RoW

TILD, matching placebo injections

Sun Pharmaceutical Industries Limited

Active Psoriatic Arthritis

09/24

12/24

NCT04314544: Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1)

Recruiting

472

Europe, Canada, US, RoW

TILD, matching placebo injections

Sun Pharmaceutical Industries Limited

Active Psoriatic Arthritis

06/24

03/25

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

03/25

09/25

NCT04991116: Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis

Recruiting

650

Europe, Japan, US, RoW

TILD sub-cutaneous (SC) injection

Sun Pharmaceutical Industries Limited

Psoriatic Arthritis

09/25

01/26

NCT06104124: A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease Activity

Recruiting

510

Japan, US, RoW

Dazodalibep, VIB 4920, MEDI 4920, Placebo

Amgen

Sjogren's Syndrome

07/26

SIRIUS-SLE 1, NCT05639114 / 2022-002691-36: Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus

Recruiting

406

Europe, Canada, Japan, US, RoW

Ianalumab, VAY736, Placebo

Novartis Pharmaceuticals, Novartis Pharma AG

Systemic Lupus Erythematosus

01/27

01/29

RESOLUTION-1, NCT05516758: A Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid Arthritis

Active, not recruiting

491

Europe, Canada, Japan, US, RoW

Peresolimab, Placebo

Eli Lilly and Company

Rheumatoid Arthritis, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, Connective Tissue Diseases, Autoimmune Diseases, Immune System Diseases

11/23

01/25

NCT03631225: The Effect of Guided Care With Vectra Compared to Treatment as Usual in Patients With Rheumatoid Arthritis

Recruiting

N/A

1500

Vectra

Sequenom, Inc., Laboratory Corporation of America

Rheumatoid Arthritis (RA)

09/25

Lazaro, Maria Alicia

NCT05848258: An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis

Recruiting

380

Europe, US, RoW

LY3871801, Placebo

Eli Lilly and Company, Rigel Pharmaceuticals

Rheumatoid Arthritis

02/26

07/26

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

Active, not recruiting

532

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

07/24

08/24

Zamora, Jose Luis Velasco

BE-EARLY, NCT06411249: A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE)

Recruiting

350

Europe, Japan, US, RoW

Belimumab (GSK1550188), BEL (BENLYSTA)

GlaxoSmithKline

Systemic Lupus Erythematosus

04/27

05/29

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

Recruiting

2/3

474

Europe, Canada, Japan, US, RoW

BIIB059 (litifilimab), litifilimab, Placebo

Biogen, Biogen Idec Research Limited

Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus

10/26

12/27

Rodgers, Timothy

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

Recruiting

1000

Europe, Canada, US

TAK-279, Placebo, Apremilast

Takeda

Plaque Psoriasis

07/25

06/26

Recruiting

2/3

474

Europe, Canada, Japan, US, RoW

BIIB059 (litifilimab), litifilimab, Placebo

Biogen, Biogen Idec Research Limited

Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus

10/26

12/27

NCT06436183: A Study of the Effects of Camoteskimab in Adults With Moderate to Severe Atopic Dermatitis

Recruiting

Canada, US

Camoteskimab, APL-9109, AVTX-007, CERC-007, AEVI-007, MEDI2338, Placebo

Apollo Therapeutics Ltd

Atopic Dermatitis, Atopic, Dermatitis, Dermatologic Disease, Eczema, Eczema Atopic Dermatitis, Eczema, Atopic

02/25

06/25

NCT06046729: A Study of Eltrekibart (LY3041658) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Recruiting

350

Europe, Canada, US, RoW

Eltrekibart, LY3041658, Placebo

Eli Lilly and Company

Hidradenitis Suppurativa

08/25

07/26

TARGET-DERM, NCT03661866: A Longitudinal Observational Study of Patients Undergoing Therapy for IMISC

Recruiting

N/A

15000

Europe, Canada, US

Target PharmaSolutions, Inc.

Atopic Dermatitis, Alopecia Areata, Hidradenitis Suppurativa, Vitiligo, Psoriasis, Chronic Spontaneous Urticaria

12/50

Basu, Dhiman

BE-EARLY, NCT06411249: A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE)

Recruiting

350

Europe, Japan, US, RoW

Belimumab (GSK1550188), BEL (BENLYSTA)

GlaxoSmithKline

Systemic Lupus Erythematosus

04/27

05/29

SELUNE, NCT04181762 / 2019-003211-57: Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis

Terminated

275

Europe, Canada, Japan, US, RoW

secukinumab, AIN457

Novartis Pharmaceuticals

Lupus Nephritis

09/23

RESET-RA, NCT04539964: Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis

Active, not recruiting

250

Implant Procedure, Surgical placement of vagus nerve stimulator inside the neck, Conventional Synthetic DMARD, Background therapy with conventional synthetic DMARD, Active stimulation, Non-active stimulation

SetPoint Medical Corporation

Rheumatoid Arthritis

05/24

10/27

NCT04314531: Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti-TNF naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2)

Active, not recruiting

292

Europe, Japan, US, RoW

TILD, matching placebo injections

Sun Pharmaceutical Industries Limited

Active Psoriatic Arthritis

09/24

12/24

NCT04314544: Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1)

Recruiting

472

Europe, Canada, US, RoW

TILD, matching placebo injections

Sun Pharmaceutical Industries Limited

Active Psoriatic Arthritis

06/24

03/25

	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

03/25

09/25

NEPTUNUS-1, NCT05350072 / 2020-005661-14: Two-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome

Active, not recruiting

276

Europe, US, RoW

VAY736, Placebo

Novartis Pharmaceuticals, Novartis Pharma AG

Sjogren Syndrome

03/26

03/28

Recruiting

2/3

474

Europe, Canada, Japan, US, RoW

BIIB059 (litifilimab), litifilimab, 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)

Active, not recruiting

532

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

07/24

08/24

NCT05781750: A Study of Zetomipzomib (KZR-616) in Patients With Active Lupus Nephritis (PALIZADE)

Recruiting

279

Europe, US, RoW

zetomipzomib, KZR-616, placebo, matching placebo

Kezar Life Sciences, Inc.

Lupus Nephritis

05/26

07/26

Brionez, Tamar

SERENITY CM, NCT05614648: Sciatica Epidural Radiculopathy Experimental New Interventional TherapY Clonidine Micropellet

Terminated

Clonidine Micropellets, Tuohy epidural needle

Sollis Therapeutics, Inc.

Lumbosacral Radiculopathy

03/24

GCAptAIN, NCT04930094: Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Giant Cell Arteritis (GCA)

Active, not recruiting

354

Europe, Canada, US, RoW

Secukinumab 300 mg, AIN457, Placebo, Placebo Comparator, Secukinumab 150 mg

Novartis Pharmaceuticals

Giant Cell Arteritis (GCA)

04/25

07/27

	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

03/25

09/25

REPLENISH, NCT05767034: Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)

Recruiting

360

Europe, Canada, Japan, US, RoW

Secukinumab 300 mg, AIN457, Secukinumab 150 mg, Placebo to secukinumab

Novartis Pharmaceuticals

Polymyalgia Rheumatica

09/25

02/26

NEPTUNUS-2, NCT05349214 / 2021-005687-22: Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome

Recruiting

489

Europe, Canada, Japan, US, RoW

VAY736, Placebo

Novartis Pharmaceuticals, Novartis Pharma AG

Sjogren Syndrome

03/26

03/28

NEPTUNUS-Ext, NCT05985915: A Randomized, Double-blind 2-arm NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome.

Recruiting

600

Europe, Canada, Japan, US, RoW

Ianalumab (VAY736), Placebo

Novartis Pharmaceuticals

Sjogrens Syndrome

08/28

07/30

NCT05690204: Dose Finding Study to Evaluate Safety and Efficacy of 3 Dosages of SAP 001.

Recruiting

SAP001, Xanthine Oxidase Inhibitor, Colchicine

Shanton Pharma Co., Ltd.

Gout

12/24

01/25

Testa, Gladys Alicia

Recruiting

540

Europe, Canada, Japan, US, RoW

Litifilimab, BIIB059, Placebo

Biogen

Lupus Erythematosus, Systemic

09/25

03/26

Recruiting

2/3

474

Europe, Canada, Japan, US, RoW

BIIB059 (litifilimab), litifilimab, 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)

Active, not recruiting

532

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

07/24

08/24

MARS-17, NCT05838742: A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults With Knee Osteoarthritis Pain

Recruiting

420

Europe, Canada, Japan, US, RoW

GSK3858279, Placebo

GlaxoSmithKline

Pain

07/25

10/25

Oparanov, Boycho

	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

03/25

09/25

Recruiting

2/3

474

Europe, Canada, Japan, US, RoW

BIIB059 (litifilimab), litifilimab, 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)

Active, not recruiting

532

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

07/24

08/24



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