Dose-Ranging Study of the Efficacy and Safety of TAK-101 for Prevention of Gluten-Specific T Cell Activation in Participants With Celiac Disease on a Gluten-Free Diet
- Conditions
- Celiac Disease
- Interventions
- Registration Number
- NCT04530123
- Lead Sponsor
- Takeda
- Brief Summary
The main aim of the study is to assess if TAK-101 can reduce gluten related symptoms and immune activation in adult participants with celiac disease (CeD) on a gluten-free diet (GFD).
Participants will receive TAK-101 and/or placebo through the vein on Day 1 and Day 8. All participants will receive active treatment at Week 24.
- Detailed Description
The drug being tested in this study is called TAK-101. TAK-101 is being tested to treat people who have celiac disease. The study has two cohorts planned. The first cohort has 1 dose level and the second cohort may include 1 or 2 dose levels, depending on safety, tolerability, and activity observed in the first cohort. Dosing in the second cohort will be based on data from the initial cohort.
The study will enrol approximately 108 patients (18 per arm). In the first cohort, approximately 45 participants will be randomly assigned in 1:2:2 ratio in one of the three arm groups which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need). Eligible participants in Cohort 1 will receive:
* Group A: 2 infusion doses of placebo, 1 on Day 1 and 1 on Day 8, followed by 1 infusion dose of 2 mg/kg TAK-101 at Week 24.
* Group B: 1 infusion dose of 2 mg/kg of TAK-101 on Day 1 followed by 1 infusion dose of placebo on Day 8, followed by 1 infusion dose of 2 mg/kg TAK-101 at Week 24.
* Group C: 2 infusion doses of 2 mg/kg of TAK-101, 1 on Day 1 and 1 on Day 8, followed by 1 infusion dose of 2 mg/kg TAK-101 at Week 24.
After the review of Cohort 1 safety data, a decision will be made to either stop the study or continue the study by the sponsor safety management team (SMT), based on recommendations from independent data monitoring committee (IDMC). If it is deemed appropriate to enroll both the TAK-101 4 mg/kg and 1 mg/kg dose level, approximately 63 participants may be randomly assigned in 1:2:2:2 ratio in Cohort 2 to receive:
* Group D: Two infusion doses of placebo, 1 on Day 1 and 1 on Day 8, followed by 1 infusion dose of 2 mg/kg TAK-101 at Week 24.
* Group E: One infusion dose of 4 mg/kg TAK-101 on Day 1 followed by 1 infusion dose of placebo on Day 8, followed by 1 infusion dose of 4 mg/kg TAK-101 at Week 24.
* Group F: Two infusion doses of 4mg/kg, 1 on Day 1 and 1 on day 8, followed by 1 infusion dose of 4 mg/kg TAK-101 at Week 24.
* Group G: TAK-101 1 mg/kg: Two infusion doses of 1 mg/kg TAK-101, 1 on Day 1 and 1 on Day 8, followed by 1 infusion dose of 1 mg/kg TAK-101 at Week 24 (1 mg/kg may not be needed based on review of Cohort 1 data).
In Cohort 2 if the 1 mg/kg treatment arm is not needed, Cohort 2 will consist of 45 participants in total, being randomized in a 1:2:2 ratio to 1 of the 3 treatment groups (Groups D, E, F) listed above.
If it is decided not to open the second cohort at the 4 mg/kg dose level and if 1 mg/kg dose is recommended to be tested by the IDMC, approximately 45 participants will be randomly assigned in 1:2:2 ratio to receive:
* Group D: Two infusion doses of placebo, 1 on Day 1 and 1 on Day 8, followed by 1 infusion dose of 1 mg/kg TAK-101 at Week 24.
* Group E: One infusion dose of 1 mg/kg TAK-101 on Day 1 followed by 1 infusion dose of placebo on Day 8, followed by 1 infusion dose of 1 mg/kg TAK-101 at Week 24.
* Group F: Two infusion doses of 1 mg/kg, 1 on Day 1 and 1 on Day 8, followed by 1 infusion dose of 1 mg/kg TAK-101 at Week 24.
This trial will be conducted in United States and Canada. The overall time to participate in this study is approximately 24 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone OR plus a final visit after receiving their last dose of study drug for a follow-up assessment.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 17
-
Biopsy-confirmed CeD that is well-controlled, defined as mild or with no ongoing signs or symptoms felt to be related to active CeD and with immunoglobulin A (IgA) tissue transglutaminase (tTG) <2 × upper limit of normal (ULN) and IgG deamidated gliadin peptide (DGP) <3 × ULN.
Note: Participants may be retested for IgA tTG and IgG DGP to meet eligibility criteria at the discretion of the investigator. Intermittent symptoms would not exclude participants from participation as long as symptoms are generally well controlled in the opinion of the investigator, and as long as symptoms are back to baseline for 2 weeks before the run-in gluten challenge.
-
Must be attempting to maintain a gluten-free diet (GFD) for ≥6 months.
-
Must be HLA-DQ2 and/or HLA-DQ8 positive during screening laboratory testing.
- Has received any investigational compound within 12 weeks (84 days) before signing of the informed consent or during the current study.
- Has received TAK-101 (TIMP-GLIA) in a previous clinical study or as a therapeutic agent.
- Has presence of inflammatory gastrointestinal disorders or autoimmune diseases, other than well-controlled autoimmune thyroid disease or well-controlled type 1 diabetes mellitus (defined as glycosylated hemoglobin <8% and no hospitalization in the last 12 months for hyper/hypoglycemia).
- Has known or suspected refractory CeD or ulcerative jejunitis.
- Has additional food allergies or intolerances that prevent participation in the food challenge.
- Is receiving ongoing systemic immunosuppressant, systemic (oral or IV) corticosteroid treatment, or has received treatment with systemic immunosuppressants or corticosteroids in the 12 weeks before run-in gluten challenge.
- Has known or suspected chronic liver disease or positive for hepatitis B or C.
- Has intolerable symptoms after the run-in gluten challenge and is unwilling to undergo subsequent posttreatment gluten challenges.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2, Group A: Placebo + Placebo + TAK-101 25 µg/kg GE TAK-101 Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 placebo-matching IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 25 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1. Cohort 1, Group A: Placebo + Placebo + TAK-101 25 µg/kg GE Placebo Following a single-day 3 gram (g) oral run-in gluten challenge, participants will receive TAK-101 placebo-matching intravenous (IV) infusion dose, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 25 microgram per kilogram (µg/kg) GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 1, Group A: Placebo + Placebo + TAK-101 25 µg/kg GE TAK-101 Following a single-day 3 gram (g) oral run-in gluten challenge, participants will receive TAK-101 placebo-matching intravenous (IV) infusion dose, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 25 microgram per kilogram (µg/kg) GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 1, Group A: Placebo + Placebo + TAK-101 25 µg/kg GE Gluten Following a single-day 3 gram (g) oral run-in gluten challenge, participants will receive TAK-101 placebo-matching intravenous (IV) infusion dose, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 25 microgram per kilogram (µg/kg) GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 1, Group B: TAK-101 25 µg/kg GE + Placebo + TAK-101 25 µg/kg GE Placebo Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 25 µg/kg, IV infusion once on Day 1 followed by TAK-101 placebo-matching IV infusion, once on Day 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 25 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 1, Group B: TAK-101 25 µg/kg GE + Placebo + TAK-101 25 µg/kg GE TAK-101 Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 25 µg/kg, IV infusion once on Day 1 followed by TAK-101 placebo-matching IV infusion, once on Day 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 25 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 1, Group B: TAK-101 25 µg/kg GE + Placebo + TAK-101 25 µg/kg GE Gluten Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 25 µg/kg, IV infusion once on Day 1 followed by TAK-101 placebo-matching IV infusion, once on Day 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 25 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 1, Group C: TAK-101 25 µg/kg GE + TAK-101 25 µg/kg GE + TAK-101 25 µg/kg GE TAK-101 Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 25 µg/kg GE IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 25 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 1, Group C: TAK-101 25 µg/kg GE + TAK-101 25 µg/kg GE + TAK-101 25 µg/kg GE Gluten Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 25 µg/kg GE IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 25 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 2, Group A: Placebo + Placebo + TAK-101 25 µg/kg GE Placebo Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 placebo-matching IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 25 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1. Cohort 2, Group A: Placebo + Placebo + TAK-101 25 µg/kg GE Gluten Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 placebo-matching IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 25 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1. Cohort 2, Group D: TAK-101 50 µg/kg GE + TAK-101 50 µg/kg GE+ TAK-101 50 µg/kg GE TAK-101 Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 50 µg/kg GE IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 50 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1. Cohort 2, Group D: TAK-101 50 µg/kg GE + TAK-101 50 µg/kg GE+ TAK-101 50 µg/kg GE Gluten Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 50 µg/kg GE IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 50 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1. Cohort 2, Group E: Placebo + Placebo + TAK-101 12.5 µg/kg GE Placebo Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 placebo-matching IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 12.5 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1. This group would be opened only if it is decided not to open Cohort 2 at the 50 µg/kg GE dose level. Cohort 2, Group E: Placebo + Placebo + TAK-101 12.5 µg/kg GE TAK-101 Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 placebo-matching IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 12.5 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1. This group would be opened only if it is decided not to open Cohort 2 at the 50 µg/kg GE dose level. Cohort 2, Group E: Placebo + Placebo + TAK-101 12.5 µg/kg GE Gluten Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 placebo-matching IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 12.5 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1. This group would be opened only if it is decided not to open Cohort 2 at the 50 µg/kg GE dose level. Cohort 2, Group F: TAK-101 12.5 µg/kg GE + TAK-101 12.5 µg/kg GE + TAK-101 12.5 µg/kg GE TAK-101 Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 12.5 µg/kg GE IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 12.5 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1. Cohort 2, Group F: TAK-101 12.5 µg/kg GE + TAK-101 12.5 µg/kg GE + TAK-101 12.5 µg/kg GE Gluten Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 12.5 µg/kg GE IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 12.5 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1.
- Primary Outcome Measures
Name Time Method Change From Baseline in Interferon-gamma Spot Forming Units (IFN-γ SFUs) in Human Leukocyte Antigens Density Quotient (HLA-DQ2.5-positive) Participants Based on Results of a Gliadin-Specific Enzyme-Linked Immunospot (ELISpot) Assay Baseline (Day 15, or Day 1 in the absence of Day 15) to Week 3 (Day 20) IFN-γ SFUs will be measured based on results of a gliadin-specific ELISpot assay using gluten-specific T cells which will be isolated from blood.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Experiencing at Least One Adverse Event (AE) and Adverse Events of Special Interest (AESIs) From the first IV dose up to 30 days after last IV dose (Up to Week 28) An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a markedly abnormal physical examination finding, vital sign value, laboratory test value), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. An AESI (serious or nonserious) is one of scientific and medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor may be appropriate.
Change From Run-in (Visit 2) to Weeks 8, 14, and 20 in the Pre- to Post-gluten Challenge Change of the 3-day Average Nausea Severity Score as Measured in Celiac Disease Symptom Diary (CDSD) Run-in (Visit 2), Weeks 8, 14, and 20 The CDSD version 2.1 is an 8-item, self-administered questionnaire that evaluates the celiac disease (CeD) symptoms using 5-point Likert-type scales, where lower score indicating no symptoms and higher score indicating severe symptoms for all items except for frequency questions relating to stool counts, diarrhea, and vomiting frequency. The scores from the past 3 days with a 24-hour recall period will be averaged. For Weeks 8, 14, and 20, it is calculated as the average of the available daily scores recorded in the 3 days prior and after the respective gluten challenge.
Change From Run-in (Visit 2) to Weeks 8,14, and 20 in the Pre- to Post-gluten Challenge Change in CDSD 3-day Peak Nausea Severity Score Run-in (Visit 2), Weeks 8, 14, and 20 The CDSD version 2.1 is an 8-item, self-administered questionnaire that evaluates the CeD symptoms using 5-point Likert-type scales, where lower score indicating no symptoms and higher score indicating severe symptoms for all items except for frequency questions relating to stool counts, diarrhea, and vomiting frequency. The scores from the past 3 days with a 24-hour recall period will be averaged. Peak score is the highest score in the 3 days prior and following gluten challenge at Weeks 8, 14, and 20.
Change From Run-in (Visit 2) to Weeks 8, 14, and 20 in the Pre- to Post-gluten Challenge Change in Weekly Gastrointestinal (GI) Symptom Severity Score Run-in (Visit 2), Weeks 8, 14, and 20 The CDSD version 2.1 is an 8-item, self-administered questionnaire that evaluates the CeD symptoms using 5-point Likert-type scales, where lower score indicating no symptoms and higher score indicating severe symptoms for all items except for frequency questions relating to stool counts, diarrhea, and vomiting frequency. GI symptom severity score ranges from 0 to 20 with higher score indicating more severe disease.
Fold Change in Plasma Interleukin-2 (IL-2) from Run-in (Visit 2) to Day 15, and Weeks 8, 14, and 20 Pre-/post-gluten challenge at Run-in (Visit 2), Day 15, and Weeks 8, 14, and 20 The pre-/post-gluten challenge fold change in plasma IL-2 from Run-in (Visit 2) to Day 15, and Weeks 8, 14, and 20 will be compared.
Fold Change in Plasma IL-2 at Specified Time Points Pre-/post-gluten challenge at Run-in (Visit 2), Day 15, and Weeks 8, 14, and 20 The pre-/post-gluten challenge fold change in plasma IL-2 at each of the time points will be compared.
Plasma Concentration of TAK-101 After Each Dose Predose and postdose at Weeks 0, 1 and 24 Serum Concentration of Antidrug Antibody (ADAs) to Various Doses of TAK-101 Predose at Week 1 and before gluten challenge at Weeks 2, 14, 20, and 24 ADA includes deamidated gliadin peptide- immunoglobulin G (DGP- IgG).
Trial Locations
- Locations (48)
Cadena Care Institute, Inc.
🇺🇸Poway, California, United States
Asthma and Allergy Associates, PC
🇺🇸Colorado Springs, Colorado, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Lemah Creek Clinical Research
🇺🇸Burr Ridge, Illinois, United States
Berkshire Medical Center
🇺🇸New Albany, Indiana, United States
Gastroenterology Health Partners, PLLC
🇺🇸New Albany, Indiana, United States
Agile Clinical Research Trials
🇺🇸Atlanta, Georgia, United States
Gastroenterology Associates, PA
🇺🇸Rockford, Illinois, United States
Boston Specialists
🇺🇸Boston, Massachusetts, United States
Berkshire Medical Center, Inc.
🇺🇸Pittsfield, Massachusetts, United States
Wellness Clinical Research
🇺🇸Chesterfield, Michigan, United States
Albuquerque Clinical Trials, Inc.
🇺🇸Albuquerque, New Mexico, United States
Basil Clinical
🇺🇸Inwood, New York, United States
One of a Kind Clinical Research Center LLC
🇺🇸Scottsdale, Arizona, United States
Gastroenterology and Liver Institute
🇺🇸Escondido, California, United States
GCP Clinical Research, LLC
🇺🇸Tampa, Florida, United States
Rockford Gastroenterology Associates, Ltd.
🇺🇸Rockford, Illinois, United States
Clinical Research Institute of Michigan, LLC
🇺🇸Chesterfield, Michigan, United States
Mayo Clinic - Rochester
🇺🇸Rochester, Minnesota, United States
Mount Sinai
🇺🇸New York, New York, United States
Columbia University Medical Center. New York Presbyterian Hospital
🇺🇸New York, New York, United States
East Carolina Gastroenterology, PA
🇺🇸Jacksonville, North Carolina, United States
GI Alliance-Rhode Island
🇺🇸Providence, Rhode Island, United States
Amel Med LLC
🇺🇸Georgetown, Texas, United States
Care Access Research - Salt Lake City
🇺🇸Ogden, Utah, United States
Royal Melbourne Hospital
🇦🇺Parkville, AU, Australia
Emeritus Research, Sydney
🇦🇺Botany, NS, Australia
Coral Sea Clinical Research Institute
🇦🇺North Mackay, Queensland, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
Emeritus Research, Melbourne
🇦🇺Camberwell, Victoria, Australia
The Northern Hospital
🇦🇺Epping, Victoria, Australia
St John of God Midland
🇦🇺Midland, Western Australia, Australia
St Vincent's Hospital Melbourne
🇦🇺Fitzroy, Australia
Mater Hospital Brisbane
🇦🇺South Brisbane, Australia
Gastroenterology and Internal Medicine Research Institute (GIRI)
🇨🇦Edmonton, Alberta, Canada
PerCuro Clinical Research Ltd.
🇨🇦Victoria, British Columbia, Canada
McMaster University
🇨🇦Hamilton, Ontario, Canada
Scott Shulman Medicine Professional Corporation
🇨🇦North bay, Ontario, Canada
DIEX Recherche Quebec Inc.
🇨🇦Quebec, Canada
Silverdale Medical
🇳🇿Silverdale, Auckland, New Zealand
Optimal Clinical Trials - North
🇳🇿Auckland, AU, New Zealand
Southern Clinical Trials Totara
🇳🇿New Lynn, AU, New Zealand
Momentum Clinical Research Dunedin
🇳🇿Dunedin, OT, New Zealand
P3 Research Limited (Wellington)
🇳🇿Wellington, OT, New Zealand
Capital, Coast and Hutt Valley - Wellington Regional Hospital
🇳🇿Boulcott, WG, New Zealand
Lakeland Clinical Trials Wellington
🇳🇿Upper Hutt, WG, New Zealand
Optimal Clinical Trials - Central
🇳🇿Grafton, New Zealand