Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)

NCT05722938 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 996
• Study Type: interventional
• Target: 590
• Locations: 17 countries
• Sites: 164

Brief Summary

The main objective of the trial is to assess the efficacy and safety of trimodulin as adjunctive treatment to standard of care (SoC) compared to placebo plus SoC in hospitalized subjects with sCAP on invasive mechanical ventilation (IMV). Other objectives are to determine detailed pharmacokinetic (PK) properties of trimodulin in a PK substudy and to determine its pharmacodynamic (PD) properties.

Conditions

Community-acquired Pneumonia

Keywords

Severe Community-acquired Pneumonia

Outcome Measures

Primary Outcomes (1)

• 28-day all-cause mortality rate

  Percentage of subjects that died until day 29 regardless of cause of death

  Between days 1-29

Secondary Outcomes (25)

• 90-day all-cause mortality rate

  Between days 1-91

• Deterioration rate (up to day 29)

  Up to day 29

• Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day 7

  Between baseline and Day 7

• Proportion of subjects with clinical cure of pneumonia up to day 29

  Up to day 29

• Days of invasive mechanical ventilation (IMV) up to day 29

  Up to day 29

Other Outcomes (3)

• Serum concentration of immunoglobulins

  Day 1, 5, 14

• Pharmacokinetic assessment of immunoglobulins

  Day 1, 2, 3, 4, 5, 6, 7, 9, 14, 21, 29

• Pharmacodynamic assessment of disease related serum proteins

  Day 1, 2, 3, 4, 5, 7, 14, 21, 29

Study Arms (2)

Trimodulin

EXPERIMENTAL

Trimodulin (human IgM, IgA, IgG solution) for intravenous (IV) administration.

Drug: Trimodulin

Placebo

PLACEBO COMPARATOR

Human albumin 1%

Drug: Placebo (human albumin 1%)

Interventions

Trimodulin DRUG

IMP will be administered via IV infusion on 5 consecutive days

Also known as: BT588

Trimodulin

Placebo (human albumin 1%) DRUG

IMP will be administered via IV infusion on 5 consecutive days

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent.
• Hospitalized, adult (≥ 18 years of age) subject; In US only: ≥ 12 years of age
• Signs of inflammation based on C-reactive protein threshold level.
• Diagnosis of active community-acquired pneumonia (CAP) before hospital-admission or within 48 hours after admission.
• Radiological (or other imaging technology) evidence consistent with active pneumonia.
• Acute respiratory failure requiring IMV.

You may not qualify if:

• Pregnant or lactating women.
• Subjects of childbearing potential not willing to use reliable contraceptive measures during the trial and for 15 weeks after the last IMP treatment.
• Subjects on ECMO at start of IMP treatment.
• Suspected hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP).
• Subjects discharged from hospital within the previous 14 days.
• Defined neutrophil counts up to one calendar day prior to start of IMP treatment.
• Defined platelet counts up to one calendar day prior to start of IMP treatment.
• Defined hemoglobin within up to one calendar day prior to start of IMP treatment.
• Pre-existing hemolytic disease.
• Thromboembolic events (TEEs) caused by other reasons than the current sCAP within 3 months before start of IMP treatment unless the risk for further TEEs can be adequately managed with standard prophylaxis or treatment.
• Severe renal impairment prior to start of IMP treatment.
• End-stage renal disease (ESRD) or known primary focal segmental glomerulosclerosis (FSGS).
• Pre-existing severe lung diseases concomitant to current sCAP (e.g. active tuberculosis, active lung cancer).
• Pre-existing decompensated heart failure.
• Pre-existing severe hepatic cirrhosis (Child Pugh score ≥ 10 points), or severe hepatic impairment (Child Pugh score ≥ 10 points), or hepatocellular carcinoma.

Sponsors & Collaborators

• Biotest: lead

Study Sites (170)

#1012 Pulmonary Associates of Mobile, P.C.

Mobile, Alabama, 36608, United States

WITHDRAWN

# 1033 Banner University Medical Center

Phoenix, Arizona, 85006, United States

NOT YET RECRUITING

#1007 University of California San Francisco-Fresno

Fresno, California, 93701, United States

RECRUITING

# 1015 UC Davis Health

Sacramento, California, 95817, United States

WITHDRAWN

# 1002 Augusta University

Augusta, Georgia, 30912, United States

WITHDRAWN

# 1028 University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

NOT YET RECRUITING

# 1034 Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

NOT YET RECRUITING

# 1010 Sparrow Clinical Research Institute Site 1010

Lansing, Michigan, 48912, United States

WITHDRAWN

# 1003 William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

WITHDRAWN

#1009 University of Missouri Clinical Research Center

Columbia, Missouri, 65212, United States

WITHDRAWN

# 1006 Hannibal Clinic

Hannibal, Missouri, 63401, United States

WITHDRAWN

# 1005 Mercury Street Medical Group

Butte, Montana, 59701, United States

WITHDRAWN

# 1001 St. Michael's Medical Center

Newark, New Jersey, 07102, United States

WITHDRAWN

# 1011 Buffalo VA Medical Center

Buffalo, New York, 14215, United States

WITHDRAWN

# 1021 Northern Westchester Hospital

Mount Kisco, New York, 10549, United States

RECRUITING

# 1030 NYU Langone Medical Center (Tisch Hospital)

New York, New York, 10016, United States

NOT YET RECRUITING

# 1031 Health Hospitals Bellvue

New York, New York, 10016, United States

NOT YET RECRUITING

# 1023 Mount Sinai Hospital

New York, New York, 10029, United States

NOT YET RECRUITING

# 1032 NYC Langone Brooklyn

New York, New York, 11220, United States

NOT YET RECRUITING

# 1017 Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

RECRUITING

# 1025 University of Cincinnati College of Medicine

Cincinnati, Ohio, 45267, United States

NOT YET RECRUITING

# 1004 Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

ACTIVE NOT RECRUITING

# 1013 University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

WITHDRAWN

# 1016 Jefferson University Hospitals

Philadelphia, Pennsylvania, 19107, United States

WITHDRAWN

# 1018 Vanderbilt University Medical Cente

Nashville, Tennessee, 37232, United States

WITHDRAWN

# 1020 Medical City Fort Worth

Fort Worth, Texas, 76104, United States

WITHDRAWN

# 1022 Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

# 1022 Houston Methodist Hospital

Houston, Texas, 77030, United States

NOT YET RECRUITING

# 1026 Intermountain Medical Center

Murray, Utah, 84107, United States

NOT YET RECRUITING

# 1019 University of Utah

Salt Lake City, Utah, 84108, United States

WITHDRAWN

# 5404 Sanatorio de la Trinidad Mitre

Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., C1039AAO, Argentina

WITHDRAWN

# 5413 Estudios Clinicos de los Arroyos

San Nicolás, Buenos, 2900, Argentina

RECRUITING

# 5409 Hospital San Roque

Córdoba, Córdoba Province, 5000, Argentina

WITHDRAWN

# 5412 Clinica Chutro

Córdoba, Córdoba Province, 5000, Argentina

WITHDRAWN

# 5416 Sanatorio Privado de la Canada - Cordoba

Córdoba, Córdoba Province, X5000BSQ, Argentina

WITHDRAWN

# 5405 Sanatorio Parque S.A. Privado

San Vicente, Córdoba Province, 5006, Argentina

WITHDRAWN

# 5415 Sanatorio de la Canada

Villa María, Córdoba Province, 5000, Argentina

RECRUITING

# 5420 Sanatorio Parque S.A.

Rosario, Santa Fe Province, 2000, Argentina

RECRUITING

# 5411 Centro Medico IPAM

Rosario, Santa Fe Province, CP2000, Argentina

WITHDRAWN

# 5414 Cemic

Buenos Aires, 1431, Argentina

RECRUITING

# 5406 Hospital Italiano de Buenos Aires

Buenos Aires, C1181ACH, Argentina

WITHDRAWN

# 5418 Sanatorio Guemes Site 5418

Buenos Aires, C1188AAX, Argentina

RECRUITING

# 5419 Hospital General de Agudos Dr. J. M. Ramos Mejia

Buenos Aires, C1221ADC, Argentina

RECRUITING

# 5417 Hospital Britanico de Buenos Aires

Buenos Aires, C1280AEB, Argentina

RECRUITING

# 5408 Hospital General de Agudos Dr. Ignacio Pirovano

Buenos Aires, C1430BKC, Argentina

WITHDRAWN

# 5407 Clinica Adventista Belgrano

Buenos Aires, C1430EGF, Argentina

WITHDRAWN

# 6102 Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

WITHDRAWN

# 6105 Monash Medical Centre

Clayton, Victoria, 3168, Australia

RECRUITING

# 6104 Footscray Hospital

Footscray, Victoria, 3011, Australia

RECRUITING

# 6101 Austin Health

Heidelberg, Victoria, 3084, Australia

RECRUITING

# 6103 Sunshine Hospital

Saint Albans, Victoria, 3021, Australia

RECRUITING

# 6106 Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

RECRUITING

# 4302 KABEG-Klinikum Klagenfurt

Klagenfurt, 9020, Austria

WITHDRAWN

# 4301 AKH - Medizinische Universität Wien

Vienna, 1090, Austria

WITHDRAWN

# 3212 Onze Lieve Vrouw Ziekenhuis

Aalst, 9300, Belgium

NOT YET RECRUITING

# 3207 AZ Sint-Jan

Bruges, 8000, Belgium

RECRUITING

# 3205 HUB Erasme

Brussels, 1070, Belgium

RECRUITING

# 3203 Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

# 3206 Antwerp University Hospital (UZA)

Edegem, 2650, Belgium

RECRUITING

# 3211 Zol

Genk, 3600, Belgium

RECRUITING

# 3210 AZ Maria Middelares

Ghent, 9000, Belgium

RECRUITING

# 3204 Universitair Ziekenhuis Brussel

Jette, 1090, Belgium

RECRUITING

# 3209 C. H. R. de la Citadelle

Liège, 4000, Belgium

RECRUITING

# 3208 CHU Charleroi Hôpital Civil Marie Curie

Lodelinsart, 6042, Belgium

RECRUITING

# 3201 Clinique Saint-Pierre

Ottignies, 1340, Belgium

RECRUITING

# 3213 AZ Delta VZW

Roeselare, 8800, Belgium

RECRUITING

# 5516 Hospital do Rocio

Campo Largo, Paraná, 83606-177, Brazil

RECRUITING

# 5510 Universidade de Caxias do Sul, IPCEM - Instituto de Pesquisa Clínica para Estudos Multicêntricos

Caxias do Sul, Rio Grande, 95070-560, Brazil

WITHDRAWN

# 5518 Hospital de Clínicas de Passo Fundo

Passo Fundo, Rio Grande, 99010-260, Brazil

RECRUITING

# 5503 Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande, 90020-090, Brazil

RECRUITING

# 5507 Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande, 90035-903, Brazil

WITHDRAWN

# 5509 Hospital Ernesto Dornelles

Porto Alegre, Rio Grande, 90160-093, Brazil

WITHDRAWN

# 5519 Hospital Moinhos de Vento

Porto Alegre, Rio Grande, 90560-032, Brazil

RECRUITING

# 5512 UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

Botucatu, São Paulo, 18618-686, Brazil

RECRUITING

# 5508 HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas

Campinas, São Paulo, 13060-904, Brazil

WITHDRAWN

# 5514 Universidade Municipal de Sao Caetano do Sul (USCS)

São Caetano do Sul, São Paulo, 09530-700, Brazil

WITHDRAWN

# 5513 Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

São José do Rio Preto, São Paulo, 15090-000, Brazil

RECRUITING

# 5517 Hospital Alemão Oswaldo Cruz

São Paulo, São Paulo, 01323-020, Brazil

WITHDRAWN

#4202 Fakultni nemocnice u sv. Anny v Brne

Brno, 65691, Czechia

RECRUITING

# 4203 Oblastni nemocnice Kolin a.s.

Kolín, 28002, Czechia

RECRUITING

# 4204 Hospital Kyjov

Kyjov, 69701, Czechia

RECRUITING

#4201 Fakultni nemocnice Kralovske Vinohrady

Prague, 10034, Czechia

RECRUITING

# 3317 CHU Nice-Hopital de l' Archet

Nice, Alpes Maritime, 06202, France

RECRUITING

# 3320 CHU Nice Hopital Pasteur 2

Nice, Alpes Maritime, 6100, France

WITHDRAWN

# 3321 CHU Reims - Hôpital Robert Debré

Reims, Ardennes, 51100, France

RECRUITING

# 3306 CHU Strasbourg - Nouvel Hôpital Civil

Strasbourg, Bas Rhin, 67091, France

RECRUITING

# 3308 CHU Strasbourg - Hôpital Hautepierre

Strasbourg, Bas Rhin, 67098, France

WITHDRAWN

# 3310 Hôpital Louis Mourier

Colombes, Haute de Seine, 92700, France

WITHDRAWN

# 3311 CHU de Limoges - Hôpital Dupuytren

Limoges, Haute Vienne, 87000, France

WITHDRAWN

# 3319 CHU Rennes - Hôpital Pontchaillou

Rennes, Ille Et Vilaine, 35000, France

WITHDRAWN

# 3314 CHU Tours - Hôpital Bretonneau

Tours, Indre Et Loire, 37000, France

WITHDRAWN

# 3318 CHU de Grenoble - Hôpital Albert Michallon

Grenoble, Isere, 38043, France

RECRUITING

# 3315 CHRU Lille - Hôpital Salengro

Lille, Landes, 59037, France

WITHDRAWN

# 3305 CHU Saint-Etienne

Saint-Étienne-de-Montluc, Pays de la Loire Region, 42055, France

RECRUITING

# 3303 Centre Hospitalier de Melun

Melun, Seine Maritime, 77000, France

RECRUITING

# 3302 Hôpital Nord Franche-Comté

Trévenans, Territoire De Belfort, 90400, France

WITHDRAWN

# 3309 Centre Hospitalier Victor Dupouy

Argenteuil, Val d'Oise, 95107, France

WITHDRAWN

# 3313 Hôpital Sainte Musse

Toulon, Var, 83056, France

WITHDRAWN

# 3312 Hôpital Cochin

Paris, 75014, France

RECRUITING

# 3301 Hôpital Bichat - Claude Bernard

Paris, 75018, France

RECRUITING

# 3304 Hôpital Tenon

Paris, 75020, France

TERMINATED

# 3316 Groupe Hospitalier Diaconesses - Hopital De La Croix Saint Simon

Paris, 75020, France

WITHDRAWN

# 4909 Universitaetsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

WITHDRAWN

# 4903 Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

WITHDRAWN

# 4910 Universitaetsklinikum Essen

Essen, North Rhine-Westphalia, 45147, Germany

RECRUITING

# 4904 Charité Universitätsmedizin Berlin - Campus Charité Mitte

Berlin, 10117, Germany

WITHDRAWN

# 4905 Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

WITHDRAWN

# 3606 Bugat Pal Korhaz

Gyöngyös, 3200, Hungary

WITHDRAWN

# 3607 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

Gyula, 5700, Hungary

WITHDRAWN

# 3608 Pest Megyei Flor Ferenc Korhaz

Kistarcsa, 2143, Hungary

WITHDRAWN

# 3610 Aneszteziologiai es Intenziv Terapias Intezet

Pécs, 7624, Hungary

WITHDRAWN

# 3612 Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, 6725, Hungary

WITHDRAWN

# 3604 Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

Székesfehérvár, 8000, Hungary

WITHDRAWN

# 3501 St James's Hospital

Dublin, D08NYH1, Ireland

RECRUITING

# 3503 Beaumont Hospital

Dublin, D09 V2N0, Ireland

RECRUITING

# 3504 St Vincents University Hospital

Dublin, Dublin 4, Ireland

NOT YET RECRUITING

# 3502 University Hospital Galway

Galway, H91YR71, Ireland

RECRUITING

# 9704 Soroka Medical Center

Beersheba, 8410101, Israel

RECRUITING

# 9701 Bnai Zion Medical Center

Haifa, 31048, Israel

WITHDRAWN

# 9703 Rambam Medical Center

Haifa, 31096, Israel

WITHDRAWN

# 9706 The Lady Davis Carmel Medical Center

Haifa, 3436212, Israel

WITHDRAWN

# 9702 Rabin Medical Center

Petah Tikva, 4941492, Israel

WITHDRAWN

# 9705 Kaplan Medical Center

Rehovot, 761001, Israel

RECRUITING

# 9708 Shamir Medical Center (Assaf Harofe)

Rishon LeZiyyon, 70300, Israel

RECRUITING

# 9707 Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

WITHDRAWN

# 6401 Middlemore Hospital

Otahuhu, 2025, New Zealand

RECRUITING

# 6403 Capital, Coast and Hutt Valley District - Wellington Regional Hospital

Wellington, 6021, New Zealand

RECRUITING

# 6302 Baguio General Hospital and Medical Center

Baguio City, 2600, Philippines

WITHDRAWN

# 6307 Dr. Jose N. Rodriguez Memorial Hospital

Caloocan, 1427, Philippines

RECRUITING

# 6304 Southern Philippines Medical Center

Davao City, 8000, Philippines

RECRUITING

# 6309 Davao Doctors Hospital

Davao City, 8000, Philippines

WITHDRAWN

# 6301 West Visayas State University Medical Center

Iloilo City, 5000, Philippines

RECRUITING

# 6306 St.Paul's Hospital

Iloilo City, 5000, Philippines

WITHDRAWN

# 6308 Philippine General Hospital

Manila, 1000, Philippines

RECRUITING

# 6303 Lung Center of the Philippines

Quezon City, 1100, Philippines

WITHDRAWN

# 4001 Institutul Clinic Fundeni

Bucharest, 022328, Romania

WITHDRAWN

# 4003 Spitalul Universitar de Urgenta Bucuresti

Bucharest, 050098, Romania

RECRUITING

# 4002 Spitalul Clinic Judetean de Urgenta "Pius Brinzeu"

Timișoara, 300723, Romania

WITHDRAWN

# 2706 Johese Clinical Research

Centurion, Gauteng, 0157, South Africa

WITHDRAWN

# 2707 Emmed Clinical Research

Pretoria, Gauteng, 0002, South Africa

WITHDRAWN

# 2708 Into Research

Pretoria, Gauteng, 0181, South Africa

WITHDRAWN

# 2701 Dr JM Engelbrecht Trial Site

Somerset West, Western Cape, 7130, South Africa

WITHDRAWN

# 2703 Worthwhile Clinical Trials

Johannesburg, 1500, South Africa

WITHDRAWN

# 2704 RYEXO Clinical Research Zuid Afrikaans Hospital

Pretoria, 0002, South Africa

WITHDRAWN

# 2705 RYEXO Clinical Research

Pretoria, 0184, South Africa

TERMINATED

# 3409 Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, 07120, Spain

RECRUITING

# 3423 Hospital Universitari Parc Tauli

Sabadell, Barcelona, 08208, Spain

RECRUITING

# 3419 Hospital Universitari Mutua de Terrassa

Terrassa, Barcelona, 8221, Spain

RECRUITING

# 3405 Hospital Universitario Reina Sofia

Córdoba, Cordoba, 14004, Spain

RECRUITING

# 3410 Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, 28222, Spain

WITHDRAWN

# 3418 Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

# 3420 Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

NOT YET RECRUITING

# 3414 Hospital del Mar

Barcelona, 08003, Spain

WITHDRAWN

# 3408 Hospital Clinic de Barcelona

Barcelona, 08036, Spain

RECRUITING

# 3421 Hospital Clinic de Barcelona

Barcelona, 08036, Spain

NOT YET RECRUITING

# 3406 Hospital de la Santa Creu i de Sant Pau

Barcelona, 08041, Spain

RECRUITING

# 3407 Hospital Universitari Vall d'Hebrón

Barcelona, 8035, Spain

RECRUITING

# 3417 Hospital Universitari de Bellvitge

Barcelona, 8907, Spain

RECRUITING

# 3411 Hospital Universitari de Girona Dr Josep Trueta

Girona, 17007, Spain

RECRUITING

# 3413 Hospital Universitario Clinico San Carlos

Madrid, 28040, Spain

WITHDRAWN

# 3415 Hospital Universitario La Paz

Madrid, 28046, Spain

WITHDRAWN

# 3422 Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

RECRUITING

# 3404 Hospital Universitari de Tarragona Joan XXIII

Tarragona, 43007, Spain

RECRUITING

# 3416 Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

WITHDRAWN

# 4405 Derriford Hospital

Plymouth, Devon, PL6 8DH, United Kingdom

RECRUITING

# 4401 St Thomas' Hospital

London, Greater London, SE1 7EH, United Kingdom

RECRUITING

# 4410 King's College Hospital

London, Greater London, SE5 9RS, United Kingdom

NOT YET RECRUITING

# 4403 Queen Elizabeth University Campus

Glasgow, Strathclyde, G11 6NT, United Kingdom

WITHDRAWN

# 4404 Royal Surrey County Hospital

Guildford, Surrey, GU2 7XX, United Kingdom

WITHDRAWN

# 4411 University Hospital of Wales

Cardiff, CF14 4XW, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

trimodulin

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Ricard Ferrer Roca, Dr.

  Hospital Vall d'Hebron

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Langohr

CONTACT

+491732947122; patrick.langohr@biotest.com

Claudia Schulte

CONTACT

+4915222801491; claudia.schulte@biotest.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All bottles will be indistinguishable.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized on a 1:1 basis to receive trimodulin or placebo, stratified by center

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: February 10, 2023
• Study Start: September 9, 2023
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (4); BE (12); GB (6); AU (2); IL (8); HU (6); FR (20); ES (19); BR (12); IE (4); RO (3); PH (8); ZA (7); US (30); DE (5); NZ (2); AR (16)