Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms
Sponsor
9 Meters Biopharma, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT03569007
Collaborator
(none)
307
160
3
37.7
1.9
0.1
Study Details
Study Description
Brief Summary
To assess the efficacy and safety of larazotide acetate versus placebo for the relief of persistent symptoms in adult celiac disease patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
307 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Double-blind
Primary Purpose:
Treatment
Official Title:
A Phase 3, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of Persistent Symptoms in Patients With Celiac Disease on a GFD
Actual Study Start Date
:
May 29, 2019
Actual Primary Completion Date
:
Jul 21, 2022
Actual Study Completion Date
:
Jul 21, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Larazotide 0.25 mg Larazotide 0.25 mg capsules TID |
Drug: Larazotide
Synthetic 8-amino acid peptide formulated as enteric-coated beads in gelatin capsules
Other Names:
|
| Active Comparator: Larazotide 0.50 mg Larazotide 0.50 mg capsules TID |
Drug: Larazotide
Synthetic 8-amino acid peptide formulated as enteric-coated beads in gelatin capsules
Other Names:
|
| Placebo Comparator: Placebo Matching placebo capsules TID |
Drug: Matching Placebo
enteric-coated beads in gelatin capsules
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Proportion of subjects who are binary responders [12 weeks]
Reduction in CeD PRO Abdominal Domain scores
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Male and female adults diagnosed with celiac disease (positive celiac serology plus confirmed biopsy) for at least 6 months
-
On a gluten-free diet for at least 6 months
-
Experiencing symptoms (ie, abdominal pain, abdominal cramping, bloating, gas, diarrhea, loose stool, or nausea)
-
Willing to maintain current gluten-free diet throughout participation in the study
Exclusion Criteria:
-
Refractory celiac disease or severe complications of celiac disease
-
Chronic active GI disease other than celiac disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Saraland | Alabama | United States | 36571 |
| 2 | Research Site | Scottsdale | Arizona | United States | 85251 |
| 3 | Research Site | Tucson | Arizona | United States | 85712 |
| 4 | Research Site | Tucson | Arizona | United States | 85745 |
| 5 | Research Site | North Little Rock | Arkansas | United States | 72117 |
| 6 | Research Site | Bellflower | California | United States | 90706 |
| 7 | Research Site | Beverly Hills | California | United States | 90211 |
| 8 | Research Site | Canoga Park | California | United States | 91303 |
| 9 | Research Site | Corona | California | United States | 92879 |
| 10 | Research Site | Garden Grove | California | United States | 92845 |
| 11 | Research Site | Lancaster | California | United States | 93534 |
| 12 | Research Site | Los Gatos | California | United States | 95032 |
| 13 | Research Site | Northridge | California | United States | 91324 |
| 14 | Research Site | Poway | California | United States | 92064 |
| 15 | Research Site | Rialto | California | United States | 92377 |
| 16 | Research Site | San Diego | California | United States | 92013 |
| 17 | Research Site | San Diego | California | United States | 92103 |
| 18 | Research Site | San Francisco | California | United States | 94102 |
| 19 | Research Site | Walnut Creek | California | United States | 94598 |
| 20 | Research Site | Bridgeport | Connecticut | United States | 06606 |
| 21 | Research Site | Bristol | Connecticut | United States | 06010 |
| 22 | Research Site | Hamden | Connecticut | United States | 06518 |
| 23 | Research Site | Stamford | Connecticut | United States | 06905 |
| 24 | Research Site | Boynton Beach | Florida | United States | 33472 |
| 25 | Research Site | Clearwater | Florida | United States | 33756 |
| 26 | Research Site | Inverness | Florida | United States | 34452 |
| 27 | Research Site | Lakewood Ranch | Florida | United States | 34211 |
| 28 | Research Site | Miami | Florida | United States | 33133 |
| 29 | Research Site | Orange Park | Florida | United States | 32073 |
| 30 | Research Site | Orlando | Florida | United States | 32803 |
| 31 | Research Site | Orlando | Florida | United States | 32825 |
| 32 | Research Site | Port Orange | Florida | United States | 32127 |
| 33 | Research Site | Atlanta | Georgia | United States | 30328 |
| 34 | Research Site | Columbus | Georgia | United States | 31904 |
| 35 | Research Site | Macon | Georgia | United States | 31201 |
| 36 | Research Site | Stockbridge | Georgia | United States | 30281 |
| 37 | Research Site | Stone Mountain | Georgia | United States | 30083 |
| 38 | Research Site | Sugar Hill | Georgia | United States | 30518 |
| 39 | Research Site | Boise | Idaho | United States | 83706 |
| 40 | Research Site | Idaho Falls | Idaho | United States | 83404 |
| 41 | Research Site | Arlington Heights | Illinois | United States | 60005 |
| 42 | Research Site | Fairview Heights | Illinois | United States | 62208 |
| 43 | Research Site | Melrose Park | Illinois | United States | 60160 |
| 44 | Research Site | Morton | Illinois | United States | 61550 |
| 45 | Research Site | Clive | Iowa | United States | 50325 |
| 46 | Research Site | Iowa City | Iowa | United States | 52242 |
| 47 | Research Site | West Des Moines | Iowa | United States | 50266 |
| 48 | Research Site | Topeka | Kansas | United States | 66606 |
| 49 | Research Site | Lexington | Kentucky | United States | 40509 |
| 50 | Research Site | Lexington | Kentucky | United States | 40536 |
| 51 | Research Site | Louisville | Kentucky | United States | 40202 |
| 52 | Research Site | Crowley | Louisiana | United States | 70526 |
| 53 | Research Site | Lafayette | Louisiana | United States | 70503 |
| 54 | Research Site | Marrero | Louisiana | United States | 70072 |
| 55 | Research Site | Metairie | Louisiana | United States | 70006 |
| 56 | Research Site | New Orleans | Louisiana | United States | 70115 |
| 57 | Research Site | New Orleans | Louisiana | United States | 70125 |
| 58 | Research Site | Annapolis | Maryland | United States | 21401 |
| 59 | Research Site | Baltimore | Maryland | United States | 21208 |
| 60 | Research Site | Catonsville | Maryland | United States | 21228 |
| 61 | Research Site | Columbia | Maryland | United States | 21045 |
| 62 | Research Site | Hagerstown | Maryland | United States | 21742 |
| 63 | Research Site | Boston | Massachusetts | United States | 02114 |
| 64 | Research Site | Fall River | Massachusetts | United States | 02723 |
| 65 | Research Site | Chesterfield | Michigan | United States | 48047 |
| 66 | Research Site | Rochester | Michigan | United States | 48307 |
| 67 | Research Site | Wyoming | Michigan | United States | 49519 |
| 68 | Research Site | Jackson | Minnesota | United States | 39216 |
| 69 | Research Site | Maplewood | Minnesota | United States | 55117 |
| 70 | Research Site | Rochester | Minnesota | United States | 55905 |
| 71 | Research Site | Petal | Mississippi | United States | 39465 |
| 72 | Research Site | Jefferson City | Missouri | United States | 65109 |
| 73 | Research Site | Saint Louis | Missouri | United States | 63141 |
| 74 | Research Site | Omaha | Nebraska | United States | 68114 |
| 75 | Research Site | Omaha | Nebraska | United States | 68134 |
| 76 | Research Site | Las Vegas | Nevada | United States | 89106 |
| 77 | Research Site | Las Vegas | Nevada | United States | 89109 |
| 78 | Research Site | Las Vegas | Nevada | United States | 89119 |
| 79 | Research Site | Las Vegas | Nevada | United States | 89128 |
| 80 | Research Site | Reno | Nevada | United States | 89511 |
| 81 | Research Site | Portsmouth | New Hampshire | United States | 03801 |
| 82 | Research Site | Freehold | New Jersey | United States | 07728 |
| 83 | Research Site | Ocean Township | New Jersey | United States | 07712 |
| 84 | Research Site | Albuquerque | New Mexico | United States | 87102 |
| 85 | Research Site | Great Neck | New York | United States | 11023 |
| 86 | Research Site | Mineola | New York | United States | 11501 |
| 87 | Research Site | New Windsor | New York | United States | 12553 |
| 88 | Research Site | New York | New York | United States | 10016 |
| 89 | Research Site | New York | New York | United States | 10032 |
| 90 | Research Site | New York | New York | United States | 11419 |
| 91 | Research Site | Poughkeepsie | New York | United States | 12601 |
| 92 | Research Site | Williamsville | New York | United States | 14221 |
| 93 | Research Site | Asheville | North Carolina | United States | 28801 |
| 94 | Research Site | Charlotte | North Carolina | United States | 28207 |
| 95 | Research Site | Concord | North Carolina | United States | 28025 |
| 96 | Research Site | Greenville | North Carolina | United States | 27834 |
| 97 | Research Site | Salisbury | North Carolina | United States | 28144 |
| 98 | Research Site | Winston-Salem | North Carolina | United States | 27103 |
| 99 | Research Site | Cincinnati | Ohio | United States | 45215 |
| 100 | Research Site | Cincinnati | Ohio | United States | 45219 |
| 101 | Research Site | Cleveland | Ohio | United States | 44122 |
| 102 | Research Site | Columbus | Ohio | United States | 04323 |
| 103 | Research Site | Columbus | Ohio | United States | 43214 |
| 104 | Research Site | Dayton | Ohio | United States | 45415 |
| 105 | Research Site | Dayton | Ohio | United States | 45419 |
| 106 | Research Site | Mentor | Ohio | United States | 44060 |
| 107 | Research Site | Poland | Ohio | United States | 44514 |
| 108 | Research Site | Norman | Oklahoma | United States | 73071 |
| 109 | Research Site | Oklahoma City | Oklahoma | United States | 73112 |
| 110 | Research Site | Tulsa | Oklahoma | United States | 74104 |
| 111 | Research Site | Happy Valley | Oregon | United States | 97086 |
| 112 | Research Site | Medford | Oregon | United States | 97504 |
| 113 | Research Site | Hershey | Pennsylvania | United States | 17033 |
| 114 | Research Site | Philadelphia | Pennsylvania | United States | 19107 |
| 115 | Research Site | Sayre | Pennsylvania | United States | 18840 |
| 116 | Research Site | Scranton | Pennsylvania | United States | 18508 |
| 117 | Research Site | Lincoln | Rhode Island | United States | 02865 |
| 118 | Research Site | Warwick | Rhode Island | United States | 02886 |
| 119 | Research Site | Mount Pleasant | South Carolina | United States | 29464 |
| 120 | Research Site | West Columbia | South Carolina | United States | 29169 |
| 121 | Research Site | Sioux Falls | South Dakota | United States | 57108 |
| 122 | Research Site | Chattanooga | Tennessee | United States | 37421 |
| 123 | Research Site | Nashville | Tennessee | United States | 37212 |
| 124 | Research Site | Austin | Texas | United States | 77024 |
| 125 | Research Site | Austin | Texas | United States | 78704 |
| 126 | Research Site | Austin | Texas | United States | 78726 |
| 127 | Research Site | Austin | Texas | United States | 78745 |
| 128 | Research Site | Austin | Texas | United States | 78757 |
| 129 | Research Site | Cypress | Texas | United States | 77429 |
| 130 | Research Site | Dallas | Texas | United States | 75224 |
| 131 | Research Site | DeSoto | Texas | United States | 75115 |
| 132 | Research Site | Garland | Texas | United States | 75044 |
| 133 | Research Site | Harlingen | Texas | United States | 78550 |
| 134 | Research Site | Houston | Texas | United States | 77025 |
| 135 | Research Site | Houston | Texas | United States | 77058 |
| 136 | Research Site | Houston | Texas | United States | 77084 |
| 137 | Research Site | McAllen | Texas | United States | 78503 |
| 138 | Research Site | San Antonio | Texas | United States | 78215 |
| 139 | Research Site | San Antonio | Texas | United States | 78229 |
| 140 | Research Site | Sugar Land | Texas | United States | 77476 |
| 141 | Research Site | Sugar Land | Texas | United States | 77479 |
| 142 | Research Site | Victoria | Texas | United States | 77904 |
| 143 | Research Site | Ogden | Utah | United States | 84403 |
| 144 | Research Site | Ogden | Utah | United States | 84405 |
| 145 | Research Site | Saint George | Utah | United States | 84790 |
| 146 | Research Site | Salt Lake City | Utah | United States | 84124 |
| 147 | Research Site | Sandy | Utah | United States | 84092 |
| 148 | Research Site | Chesapeake | Virginia | United States | 23320 |
| 149 | Research Site | Fairfax | Virginia | United States | 22031 |
| 150 | Research Site | Gainesville | Virginia | United States | 20155 |
| 151 | Research Site | Lansdowne Town Center | Virginia | United States | 20176 |
| 152 | Research Site | Lynchburg | Virginia | United States | 24502 |
| 153 | Research Site | Norfolk | Virginia | United States | 23507 |
| 154 | Research Site | Bellevue | Washington | United States | 98004 |
| 155 | Research Site | Bellevue | Washington | United States | 98007 |
| 156 | Research Site | Spokane | Washington | United States | 99202 |
| 157 | Research Site | Spokane | Washington | United States | 99204 |
| 158 | Research Site | Tacoma | Washington | United States | 98405 |
| 159 | Research Site | Vancouver | Washington | United States | 98664 |
| 160 | Research Site | Wauwatosa | Wisconsin | United States | 53226 |
Sponsors and Collaborators
- 9 Meters Biopharma, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
9 Meters Biopharma, Inc.
ClinicalTrials.gov Identifier:
NCT03569007
Other Study ID Numbers:
- CeD-LA-3001
First Posted:
Jun 26, 2018
Last Update Posted:
Jul 26, 2022
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: