Trial intelligence / Profile preview

TAK-101 in Well-Controlled Celiac Disease

NCT03738475Phase 2

Key facts

Status: Completed
Start: Nov 2018
Primary completion: Jun 2019
Countries: 1
Sponsor: Takeda
Modality: Polymer-based Nanoparticles, Recombinant Proteins and Enzymes

Drugs: CNP-101
Conditions: celiac disease

Overview

Phase 2, randomised, double-blind trial in celiac disease comparing TAK-101 with Placebo (2 arms). Primary endpoint: Change From Baseline in Interferon-Gamma Spot Forming Units (ELISpot) at Day 20. Started Nov 2018; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

TAK-101
8 mg/kg IV on Days 1 and 8.
Placebo
Saline IV on Days 1 and 8.

Who it enrols

Adults with biopsy-confirmed celiac disease, HLA-DQ2 or DQ2/DQ8 positive, on a gluten-free diet for at least 6 months with healed mucosa (Vh:Cd >= 1.5).

Endpoints

Primary

Change From Baseline in Interferon-Gamma Spot Forming Units (ELISpot)Day 20

Secondary

Change From Baseline in Gliadin-specific T Cell ProliferationDay 20
Change From Baseline in Ratio of Villus Height to Crypt DepthDay 29
Celiac Symptom Index-ModifiedDay 35
Plasma Concentrations of TIMP-GLIADay 8
Treatment-emergent Adverse EventsDay 35

Results

Primary endpoints met

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