NCT01396213

A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease

Completed Phase 2 Last updated 20 September 2017

What this trial tests

Phase 2 trial testing Larazotide Acetate in Celiac Disease in 342 participants. Completed in 20 August 2013.

Timeline

7 November 2011

Primary endpoint
20 August 2013

20 August 2013

Quick facts

Lead sponsor	9 Meters Biopharma, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	342
Start date	7 November 2011
Primary completion	20 August 2013
Estimated completion	20 August 2013
Sites	62 locations across Canada, United States

Drugs / interventions tested

• Larazotide Acetate — full drug profile →
• placebo

Conditions studied

• Celiac Disease — all drugs for Celiac Disease →

Sponsor

9 Meters Biopharma, Inc. — full company profile →

Who can join

Adults 18 to 75, any sex, with Celiac Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A randomized, double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and safety of Larazotide Acetate in the treatment of patients with celiac disease who have persistent symptoms despite being on a gluten-free diet.

Publications & conference data

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

1. Larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet: a randomized controlled trial.
   Leffler DA, Kelly CP, Green PH, Fedorak RN, et al · · 2015 · cited 171× · PMID 25683116 · DOI 10.1053/j.gastro.2015.02.008
2. Evolving Therapy for Celiac Disease.
   Yoosuf S, Makharia GK. · · 2019 · cited 54× · PMID 31157194 · DOI 10.3389/fped.2019.00193
3. Zonulin as a Potential Therapeutic Target in Microbiota-Gut-Brain Axis Disorders: Encouraging Results and Emerging Questions.
   Veres-Székely A, Szász C, Pap D, Szebeni B, et al · · 2023 · cited 53× · PMID 37108711 · DOI 10.3390/ijms24087548
4. The present and the future in the diagnosis and management of celiac disease.
   Castillo NE, Theethira TG, Leffler DA. · · 2015 · cited 51× · PMID 25326000 · DOI 10.1093/gastro/gou065
5. Novel Nondietary Therapies for Celiac Disease.
   Alhassan E, Yadav A, Kelly CP, Mukherjee R. · · 2019 · cited 37× · PMID 31146067 · DOI 10.1016/j.jcmgh.2019.04.017
6. Current and emerging therapy for celiac disease.
   Makharia GK. · · 2014 · cited 32× · PMID 25705619 · DOI 10.3389/fmed.2014.00006
7. Development of drugs for celiac disease: review of endpoints for Phase 2 and 3 trials.
   Gottlieb K, Dawson J, Hussain F, Murray JA. · · 2015 · cited 26× · PMID 25725041 · DOI 10.1093/gastro/gov006
8. Novel avian single-chain fragment variable (scFv) targets dietary gluten and related natural grain prolamins, toxic entities of celiac disease.
   Stadlmann V, Harant H, Korschineck I, Hermann M, et al · · 2015 · cited 16× · PMID 26625857 · DOI 10.1186/s12896-015-0223-z