zamaglutenase (TAK-062) / Takeda - LARVOL DELTA

A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet (clinicaltrials.gov) - P2 | N=153 | Completed | Sponsor: Takeda | Active, not recruiting ➔ Completed | N=357 ➔ 153 | Trial completion date: May 2025 ➔ Nov 2024 | Trial primary completion date: May 2025 ➔ Nov 2024

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Celiac Disease • Immunology

A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet (clinicaltrials.gov) - P2 | N=357 | Active, not recruiting | Sponsor: Takeda | Recruiting ➔ Active, not recruiting

Enrollment closed • Celiac Disease • Immunology

A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet (clinicaltrials.gov) - P2 | N=350 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • Celiac Disease • Immunology

This clinical research study of TAK-062 (the "Takeda study drug") is for subjects with celiac disease with ongoing symptoms believed to be related to gluten exposure. They will be randomly assigned to the group receiving either placebo or the study drug. Placebo looks like the study drug but does not contain any active medicine. Subjects should follow normal gluten-free diet throughout t (clinicaltrialsregister.eu) - P2 | N=350 | Sponsor: Takeda

New P2 trial • Celiac Disease • Gastrointestinal Disorder • Immunology

"KumaMax: An enzyme designed to treat Celiac disease, now in clinical trials. @Ingrid_Pultz, @pvpbio, @TakedaPharma" (@UWproteindesign)

Clinical • Celiac Disease • Immunology

A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet (clinicaltrials.gov) - P2 | N=350 | Not yet recruiting | Sponsor: Takeda

New P2 trial • Celiac Disease • Immunology

A Study of PVP001, PVP002, and PVP003 in Healthy Adults and PVP001 and PVP002 in Adults With Celiac Disease (clinicaltrials.gov) - P1 | N=119 | Completed | Sponsor: Millennium Pharmaceuticals, Inc. | Trial completion date: Mar 2021 ➔ Jul 2021

Trial completion date • Celiac Disease • Gastroenterology • Gastrointestinal Disorder • Immunology

A Study of PVP001, PVP002, and PVP003 in Healthy Adults and PVP001 and PVP002 in Adults With Celiac Disease (clinicaltrials.gov) - P1; N=119; Completed; Sponsor: Millennium Pharmaceuticals, Inc.; Recruiting ➔ Completed

Clinical • Trial completion • Celiac Disease • Gastroenterology • Gastrointestinal Disorder • Immunology

Gluten Degradation, Pharmacokinetics, Safety, and Tolerability of TAK-062, an Engineered Enzyme to Treat Celiac Disease. (PubMed, Gastroenterology) - "TAK-062 is well tolerated, and rapidly and effectively degrades large amounts of gluten, supporting the development of this novel enzyme as an oral therapeutic for patients with CeD."

Clinical • Journal • PK/PD data • Celiac Disease • Immunology

KUMA062 EFFECTIVELY DIGESTS GLUTEN IN THE HUMAN STOMACH: RESULTS OF A PHASE 1 STUDY (DDW 2020) - "Kuma062 can degrade ≥95.5% (95% confidence interval 92.6–98.3%) of immunogenic gliadin fractions in the human stomach in physiologically relevant timeframes on or off PPI, suggesting that it may be a promising oral therapeutic for CD. Further studies are warranted."

P1 data • Celiac Disease • Immunology