NCT03805789 (MODULAATE) is a Phase 2, PHASE3 clinical trial of AAT in Acute-graft-versus-host Disease, sponsored by CSL Behring.

Who is sponsoring NCT03805789?

NCT03805789 is sponsored by CSL Behring.

What drugs are being tested in NCT03805789?

Interventions in NCT03805789: AAT, Placebo.

What condition does NCT03805789 study?

NCT03805789 studies Acute-graft-versus-host Disease.

Is NCT03805789 still recruiting?

NCT03805789 is currently active, enrolled. Last updated 4 November 2025.

Last reviewed 2025-11-04 · How we verify

NCT03805789: MODULAATE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Safety and Efficacy of Alpha-1 Antitrypsin (AAT) for the Prevention of Graft-versus-host Disease (GVHD) in Patients Receiving Hematopoietic Cell Transplant

Active, enrolled Phase 2, PHASE3 Last updated 4 November 2025

What this trial tests

Phase 2, PHASE3 trial testing AAT in Acute-graft-versus-host Disease in 222 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

27 March 2019

Primary endpoint
31 March 2026

31 March 2026

Quick facts

Lead sponsor	CSL Behring
Phase	Phase 2, PHASE3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	prevention
Enrollment	222
Start date	27 March 2019
Primary completion	31 March 2026
Estimated completion	31 March 2026
Sites	34 locations across Italy, Japan, Germany, South Korea, Australia, United States, Turkey (Türkiye), Spain

Drugs / interventions tested

AAT — full drug profile →
Placebo

Conditions studied

Acute-graft-versus-host Disease — all drugs for Acute-graft-versus-host Disease →

Sponsor

CSL Behring — full company profile →

Who can join

12 and older, any sex, with Acute-graft-versus-host Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a phase 2 / 3 prospective, double-blind, randomized, multicenter, placebo-controlled study for prevention of acute GVHD (aGVHD) in participants undergoing an unrelated (matched or single allele mismatched) or matched related allogeneic hematopoietic cell transplantation (HCT).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

GVHD Prophylaxis 2020.
Gooptu M, Antin JH. · · 2021 · cited 66× · PMID 33897681 · DOI 10.3389/fimmu.2021.605726
Endothelial cell function and endothelial-related disorders following haematopoietic cell transplantation.
Hildebrandt GC, Chao N. · · 2020 · cited 64× · PMID 32319084 · DOI 10.1111/bjh.16621
A Review of Alpha-1 Antitrypsin Binding Partners for Immune Regulation and Potential Therapeutic Application.
O'Brien ME, Murray G, Gogoi D, Yusuf A, et al · · 2022 · cited 57× · PMID 35269582 · DOI 10.3390/ijms23052441
Prevention and Treatment of Acute Graft-versus-Host Disease in Children, Adolescents, and Young Adults.
Gatza E, Reddy P, Choi SW. · · 2020 · cited 41× · PMID 31931115 · DOI 10.1016/j.bbmt.2020.01.004
Biomarker-guided preemption of steroid-refractory graft-versus-host disease with α-1-antitrypsin.
Gergoudis SC, DeFilipp Z, Özbek U, Sandhu KS, et al · · 2020 · cited 34× · PMID 33351103 · DOI 10.1182/bloodadvances.2020003336
Challenges and opportunities targeting mechanisms of epithelial injury and recovery in acute intestinal graft-versus-host disease.
Jansen SA, Nieuwenhuis EES, Hanash AM, Lindemans CA. · · 2022 · cited 24× · PMID 35654837 · DOI 10.1038/s41385-022-00527-6
Controversies and expectations for the prevention of GVHD: A biological and clinical perspective.
Watkins B, Williams KM. · · 2022 · cited 20× · PMID 36505500 · DOI 10.3389/fimmu.2022.1057694
Innovative trial approaches in immune-mediated inflammatory diseases: current use and future potential.
Grayling MJ, Bigirumurame T, Cherlin S, Ouma L, et al · · 2021 · cited 16× · PMID 34210348 · DOI 10.1186/s41927-021-00192-5

Verify or expand the search:

Other recruiting trials for Acute-graft-versus-host Disease

Currently open trials in the same condition.

NCT05236062 — Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial · NA · recruiting

Other CSL Behring trials

Trials by the same sponsor.

NCT07326592 — Phase 4, Double-blind Study Evaluating the Response on Computed Tomography (CT) Lung Density Decline Rates of Respreeza · Phase 4 · not yet recruiting
NCT07224360 — Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD) · Phase 2 · recruiting
NCT07332091 — Efficacy and Safety of Vamifeport in Adult Participants With Homeostatic Iron Regulator Gene (HFE)-Related Hereditary He · Phase 2 · recruiting
NCT07094087 — Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovasc · Phase 3 · recruiting
NCT07048262 — Dose Range Finding, Efficacy, and Safety Study of Nebulized CSL787 in Adults With Non-cystic Fibrosis Bronchiectasis (NC · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03805789 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by CSL Behring
Last refreshed: 4 November 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03805789.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing