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Efficacy and Safety of Trimod...

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

Last Updated: 2025-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

590 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-09

Study Completion Date

2026-12-31

Brief Summary

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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 adult 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.

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Detailed Description

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This is a randomized, placebo-controlled, double-blind, multi-center, multi-national, phase III trial, to assess the efficacy and safety of trimodulin compared to placebo treatment, as adjunctive treatment to SoC in adult hospitalized subjects with sCAP receiving IMV.

Subjects will be randomized on a 1:1 basis to receive trimodulin or placebo, stratified by center. Investigational medicinal product (IMP) treatments will be blinded.

Subject will be administered IMP once daily on 5 consecutive days (day 1 through day 5) adjunctive to SoC. The subsequent follow-up phase comprises maximally 23 days (day 6 through day 28) followed by an end-of-follow-up visit/telephone call on day 29 \[+3\]. For subjects still in the hospital (trial site) after day 29, an extended follow-up is conducted until discharge or until day 90. For all subjects alive on day 29, a closing visit/telephone call on day 91 \[+10\] will be done.

Conditions

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Community-acquired Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

All bottles will be indistinguishable.

Study Groups

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Trimodulin

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

Group Type EXPERIMENTAL

Trimodulin

Intervention Type DRUG

IMP will be administered via IV infusion on 5 consecutive days

Placebo

Human albumin 1%

Group Type PLACEBO_COMPARATOR

Placebo (human albumin 1%)

Intervention Type DRUG

IMP will be administered via IV infusion on 5 consecutive days

Interventions

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Trimodulin

IMP will be administered via IV infusion on 5 consecutive days

Intervention Type DRUG

Placebo (human albumin 1%)

IMP will be administered via IV infusion on 5 consecutive days

Intervention Type DRUG

Other Intervention Names

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BT588

Eligibility Criteria

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Inclusion Criteria

1. Written informed consent.
2. Hospitalized, adult (≥ 18 years of age) subject.
3. Signs of inflammation based on C-reactive protein threshold level.
4. Diagnosis of active community-acquired pneumonia (CAP) before hospital-admission or within 48 hours after admission.
5. Radiological (or other imaging technology) evidence consistent with active pneumonia.
6. Acute respiratory failure requiring IMV.

Exclusion Criteria

1. For an incapacitated subject: any indication that the subject's presumed will would be against inclusion in the trial.
2. Pregnant or lactating women.
3. Subjects of childbearing potential not willing to use reliable contraceptive measures during the trial and for 15 weeks after the last IMP treatment.
4. Subjects on ECMO or predicted to be on ECMO at start of IMP treatment.
5. Suspected hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP).
6. Subjects discharged from hospital within the previous 14 days.
7. Defined neutrophil counts within 24 hours prior to start of IMP treatment.
8. Defined platelet counts within 24 hours prior to start of IMP treatment.
9. Defined hemoglobin within 24 hours prior to start of IMP treatment.
10. Pre-existing hemolytic disease.
11. Pre-existing thrombosis or other thromboembolic events (TEEs) within 3 months before start of IMP treatment. Subjects particularly at risk for TEEs caused by other reasons than the current sCAP.
12. Subject on dialysis or with severe renal impairment within 24 hours prior to start of IMP treatment.
13. Subject with end-stage renal disease (ESRD) or known primary focal segmental glomerulosclerosis (FSGS).
14. Pre-existing severe lung diseases concomitant to current sCAP (e.g., subjects with chronic obstructive pulmonary disease \[COPD\] Gold Stage III or IV, severe interstitial lung disease \[incl. idiopathic pulmonary fibrosis\], cystic fibrosis, active tuberculosis, chronically infected bronchiectasis, or active lung cancer).
15. Pre-existing decompensated heart failure.
16. Pre-existing severe hepatic cirrhosis (Child Pugh score ≥ 10 points), or severe hepatic impairment (Child Pugh score ≥ 10 points), or hepatocellular carcinoma.
17. Known intolerance to proteins of human origin or known allergic reactions to components of trimodulin / placebo.
18. Selective immunoglobulin A (IgA) deficiency with known antibodies to IgA.
19. Life expectancy of less than 90 days, according to the investigator's clinical judgment, because of medical conditions related neither to sCAP nor to sCAP-associated septic conditions.
20. Morbid obesity with high body mass index (BMI) ≥ 40 kg/m2, or malnutrition with low BMI \< 16 kg/m2.
21. Treatment with polyvalent immunoglobulin preparations during the last 21 days before start of IMP treatment.
22. Known treatment with predefined medications, during the last 2 days before start of IMP treatment.
23. Treatment with any type of interferon during the last 21 days before start of IMP treatment
24. Subject with previous organ or hematopoietic stem cell transplantation receiving ongoing treatment with immunosuppressants (exception: corticosteroids) at start of IMP treatment.
25. Participation in another interventional clinical trial (using medications and/or procedures not according to SoC of the trial site) within 30 days before start of IMP treatment or previous IMP treatment in this clinical trial.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ricard Ferrer Roca, Dr.

Role: PRINCIPAL_INVESTIGATOR

Hospital Vall d'Hebron

Locations

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Pulmonary Associates of Mobile, P.C.

Mobile, Alabama, United States

Site Status WITHDRAWN

University of California San Francisco-Fresno

Fresno, California, United States

Site Status RECRUITING

UC Davis Health

Sacramento, California, United States

Site Status WITHDRAWN

Augusta University

Augusta, Georgia, United States

Site Status WITHDRAWN

Sparrow Clinical Research Institute

Lansing, Michigan, United States

Site Status WITHDRAWN

William Beaumont Hospital

Royal Oak, Michigan, United States

Site Status WITHDRAWN

University of Missouri Clinical Research Center

Columbia, Missouri, United States

Site Status WITHDRAWN

Hannibal Clinic

Hannibal, Missouri, United States

Site Status WITHDRAWN

Mercury Street Medical Group

Butte, Montana, United States

Site Status WITHDRAWN

St. Michael's Medical Center

Newark, New Jersey, United States

Site Status WITHDRAWN

Buffalo VA Medical Center

Buffalo, New York, United States

Site Status WITHDRAWN

Lenox Hill Hospital

New York, New York, United States

Site Status RECRUITING

Wake Forest Baptist

Winston-Salem, North Carolina, United States

Site Status RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status WITHDRAWN

Jefferson University Hospitals

Philadelphia, Pennsylvania, United States

Site Status WITHDRAWN

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status WITHDRAWN

Medical City Fort Worth

Fort Worth, Texas, United States

Site Status WITHDRAWN

Houston Methodist Hospital

Houston, Texas, United States

Site Status RECRUITING

University of Utah

Salt Lake City, Utah, United States

Site Status RECRUITING