NCT03456830 is a Phase 3 clinical trial of ALLN-177 in Enteric Hyperoxaluria, sponsored by Allena Pharmaceuticals.

Who is sponsoring NCT03456830?

NCT03456830 is sponsored by Allena Pharmaceuticals.

What drugs are being tested in NCT03456830?

Interventions in NCT03456830: ALLN-177, Placebo.

What condition does NCT03456830 study?

NCT03456830 studies Enteric Hyperoxaluria.

Is NCT03456830 still recruiting?

NCT03456830 is currently completed. Last updated 27 February 2020.

Last reviewed 2020-02-27 · How we verify

NCT03456830

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

Evaluate ALLN-177 in Patients With Enteric Hyperoxaluria

Completed Phase 3 Last updated 27 February 2020

What this trial tests

Phase 3 trial testing ALLN-177 in Enteric Hyperoxaluria in 115 participants. Completed in 28 October 2019.

Timeline

21 May 2018

Primary endpoint
30 September 2019

28 October 2019

Quick facts

Lead sponsor	Allena Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	115
Start date	21 May 2018
Primary completion	30 September 2019
Estimated completion	28 October 2019
Sites	63 locations across France, Italy, United Kingdom, Germany, Canada, United States, Spain

Drugs / interventions tested

ALLN-177 — full drug profile →
Placebo

Conditions studied

Enteric Hyperoxaluria — all drugs for Enteric Hyperoxaluria →

Sponsor

Allena Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Enteric Hyperoxaluria. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to determine the efficacy and safety of ALLN-177 in patients with enteric hyperoxaluria.

Publications & conference data

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

An engineered bacterial therapeutic lowers urinary oxalate in preclinical models and in silico simulations of enteric hyperoxaluria.
Lubkowicz D, Horvath NG, James MJ, Cantarella P, et al · · 2022 · cited 34× · PMID 35253995 · DOI 10.15252/msb.202110539
Future treatments for hyperoxaluria.
Burns Z, Knight J, Fargue S, Holmes R, et al · · 2020 · cited 14× · PMID 31895888 · DOI 10.1097/mou.0000000000000709
Randomized Placebo-Controlled Trial of Reloxaliase in Enteric Hyperoxaluria.
Lieske JC, Lingeman JE, Ferraro PM, Wyatt CM, et al · · 2022 · cited 10× · PMID 38319254 · DOI 10.1056/evidoa2100053

Verify or expand the search:

Other trials of ALLN-177

Trials testing the same drug.

NCT03391804 — Study of ALLN-177 in Patients Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia · Phase 2 · completed

Other recruiting trials for Enteric Hyperoxaluria

Currently open trials in the same condition.

NCT05124886 — Gut Kidney Axis in Enteric Hyperoxaluria · NA · recruiting

Other Allena Pharmaceuticals trials

Trials by the same sponsor.

NCT04987294 — Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease · Phase 2 · terminated
NCT05168683 — Scintigraphy Study in Healthy Volunteers to Characterize the Performance of ALLN-346 Tablets · Phase 1 · completed
NCT04987242 — An Inpatient Study of ALLN-346 (Engineered Urate Oxidase) in Hyperuricemic Subjects (Study 201) · Phase 2 · completed
NCT04829435 — Study 102: Multiple Ascending Dose Study of ALLN-346 (Engineered Urate Oxidase) · Phase 1 · completed
NCT04236219 — ALLN-346 Single Ascending Dose (SAD) Study in Healthy Volunteers · Phase 1 · completed

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 NCT03456830 (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 Allena Pharmaceuticals
Last refreshed: 27 February 2020

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/NCT03456830.

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