A Phase 3 interventional study of Larazotide and Matching Placebo in Celiac Disease, sponsored by 9 Meters Biopharma, Inc.. Terminated at 160 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-26.
Sponsored by 9 Meters Biopharma, Inc. · Phase 3, Interventional, and Treatment
To assess the efficacy and safety of larazotide acetate versus placebo for the relief of persistent symptoms in adult celiac disease patients.
This is a phase 3, randomized, double-blind, placebo-controlled, multicenter, outpatient study to evaluate the efficacy and safety of larazotide acetate for the relief of persistent symptoms in adult patients with celiac disease on a gluten free diet.
333 studies on the registry are indexed under Celiac Disease; 78 are open to participants now.
This study's enrollment of 307 is above the median of 50 across 203 interventional studies indexed under Celiac Disease.
Browse Celiac Disease studies →9 Meters Biopharma, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Larazotide 0.25 mg capsules TID
Drug: Larazotide
Larazotide 0.50 mg capsules TID
Drug: Larazotide
Matching placebo capsules TID
Drug: Matching Placebo
Synthetic 8-amino acid peptide formulated as enteric-coated beads in gelatin capsules
Also known as: INN-202
enteric-coated beads in gelatin capsules
Also known as: placebo
Proportion of subjects who are binary responders
Reduction in CeD PRO Abdominal Domain scores
Time frame: 12 weeks
Showing the first 100 of 160 sites.
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
9 Meters Biopharma, Inc.