A Study Evaluating the Efficacy and Safety of ST-0529 in Subjects With Moderately to Severely Active Ulcerative Colitis
NCT ID: NCT03844932
Last Updated: 2021-05-07
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE2
Total Enrollment
235 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-01-24
Study Completion Date
2021-04-14
Brief Summary
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Study CYC-202 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of ST-0529 in subjects with moderately to severely active UC, defined as a score of 5 to 9 on the 3-Component Adapted Mayo Score (comprised of rectal bleeding, stool frequency and endoscopy sub-scores; score range 0-9).
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Detailed Description
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The study consists of a Screening period, Treatment period and Follow-up. The Screening period is comprised of two separate in-clinic visits, SV1 and SV2. At the initial Screening visit (SV1), subjects will be required to provide written informed consent to participate in the study and will then be assessed for eligibility. Electronic diaries will be provided to subjects at this visit to use for the duration of the study in order to record information relating to their UC disease. Subjects will return to the clinic for their Screening endoscopic assessment (SV2). Ulcerative colitis disease activity for eligibility will be assessed using the 3-Component Adapted Mayo Score. Upon successful completion of the Screening period, subjects will return to the clinic for their Baseline visit.
During the Treatment period, subjects will be evaluated in the clinic at Baseline (Day 1), Week 2, Week 4, Week 8, and Week 12 (End of Treatment Period). At Week 6 and Week 10, subjects will be contacted by telephone to assess Adverse Events (AEs), concomitant medication usage and study drug regimen adherence.
Subjects who complete the 12-week Treatment period will attend the Week 16 End of Study (EOS) visit. Subjects who discontinue study drug and withdraw or are withdrawn from the study before the Week 12 visit will be requested to return to the clinic as soon as possible to complete an Early Termination (ET) visit.
During the Treatment period, subjects will be evaluated in the clinic at Baseline (Day 1), Week 2, Week 4, Week 8, and Week 12 (End of Treatment Period). At Week 6 and Week 10, subjects will be contacted by telephone to assess Adverse Events (AEs), concomitant medication usage and study drug regimen adherence.
Subjects who complete the 12-week Treatment period will attend the Week 16 End of Study (EOS) visit. Subjects who discontinue study drug and withdraw or are withdrawn from the study before the Week 12 visit will be requested to return to the clinic as soon as possible to complete an Early Termination (ET) visit.
Conditions
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Colitis, Ulcerative
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
The study will investigate ST-0529 doses of 18.75 mg BID, 37.5 mg BID, or 75 mg BID, versus matching placebo BID.
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Investigators
Outcome Assessors
The study will be conducted as a double-blind study. Both the Investigator and subjects will be blinded with respect to the treatment the subject will receive. In addition, the central reader of the endoscopy assessment will be blinded to subject treatment for the entire study.
Study Groups
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ST-0529 18.75 mg*
ST-0529: 18.75 mg orally twice daily (BID)
\*Jan 2021 update: following the IDMC recommendation, this arm has been dropped
Group Type
EXPERIMENTAL
ST-0529
Intervention Type
DRUG
ST-0529 utilizes SmPill® technology to encapsulate the otherwise insoluble cyclosporine in a presolubilized, lipid-based formulation.
ST-0529 37.5 mg*
ST-0529: 37.5 mg orally twice daily (BID)
\*Jan 2021 update: following the IDMC recommendation, this arm has been dropped
Group Type
EXPERIMENTAL
ST-0529
Intervention Type
DRUG
ST-0529 utilizes SmPill® technology to encapsulate the otherwise insoluble cyclosporine in a presolubilized, lipid-based formulation.
ST-0529 75 mg
ST-0529: 75 mg orally twice daily (BID)
Group Type
EXPERIMENTAL
ST-0529
Intervention Type
DRUG
ST-0529 utilizes SmPill® technology to encapsulate the otherwise insoluble cyclosporine in a presolubilized, lipid-based formulation.
Matching Placebo
Placebo: matching placebo orally twice daily (BID)
Group Type
PLACEBO_COMPARATOR
ST-0529
Intervention Type
DRUG
ST-0529 utilizes SmPill® technology to encapsulate the otherwise insoluble cyclosporine in a presolubilized, lipid-based formulation.
Interventions
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ST-0529
ST-0529 utilizes SmPill® technology to encapsulate the otherwise insoluble cyclosporine in a presolubilized, lipid-based formulation.
Intervention Type
DRUG
Other Intervention Names
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cyclosporine
Eligibility Criteria
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Inclusion Criteria
1. Male and female adult subjects 18 to 75 years old, inclusive.
2. Willing to provide written informed consent and to be compliant with the schedule of study visits and protocol assessments.
3. Diagnosis of UC established at least 3 months prior to the Baseline visit, by clinical and endoscopic evidence (colonoscopy or flexible sigmoidoscopy)
4. Moderately to severely active UC defined as the 3-Component Adapted Mayo Score of 5-9, inclusive, with an endoscopic sub-score of ≥ 2 (from central reading), and a rectal bleeding sub-score of ≥ 1, as determined 10 days (± 3 days) prior to Baseline.
5. Evidence of active UC, confirmed histologically (from local read), extending proximal to the rectum with ≥ 15 cm of involved colon.
6. At Screening, a colonoscopy will be required if the subject has had extensive colitis or pancolitis of \> 8 years duration or left-sided colitis of \> 12 years duration but has not had a colonoscopy within 1 year of the initial screening date. If the subject has had a colonoscopy within 1 year of the initial screening date, a flexible sigmoidoscopy may be used.
7. Subjects presenting at Screening with moderately to severely active UC demonstrating an inadequate response or loss of response or intolerance/medical contraindication to at least one of the following conventional therapies for UC:
a. Corticosteroids:
i. Signs and symptoms of active disease despite treatment with an adequate dose (e.g., prednisolone \> 40 mg/day or equivalent) over a period of 4 weeks for oral therapy or intravenously (IV) for up to 1 week or ≥ 9 mg/day oral budesonide;
OR
ii. Unable to reduce corticosteroids below the equivalent of prednisolone 10 mg daily orally within 3 months of starting steroids or having experienced a relapse within 3 months of stopping steroids;
OR
iii. History of, or current intolerance to corticosteroids (including, but not limited to Cushing's syndrome, osteopenia/osteoporosis, hyperglycemia, insomnia, infection).
b. Immunomodulators:
i. Signs and symptoms of active disease despite at least 3 months of treatment with a sufficient dose (oral azathioprine ≥ 1.5 mg/kg or 6-mercaptopurine \[6-MP\] ≥ 0.75 mg/kg);
OR
ii. History of, or current dose-limiting toxicity associated with use of the agent (e.g., but not limited to nausea/vomiting, abdominal pain, pancreatitis, liver function test \[LFT\] abnormalities, lymphopenia, TPMT genetic mutation, infection).
c. Anti-tumor necrosis factor (anti-TNF) agents:
i. Signs and symptoms of active disease despite treatment with a single anti-TNF agent. Treatment failure is defined as a relapse after an initial response to therapy as follows:
* Infliximab: At least 4 infusions of at least 5 mg/kg within a 14-week timeframe for induction and maintenance;
* Adalimumab: Induction regimen incorporating 160 mg at Week 0 (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days) and 80 mg at Week 2, followed by maintenance treatment of 40 mg every other week up to at least Week 8;
* Golimumab: Induction regimen incorporating 200 mg subcutaneous (sc) injection at Week 0, followed by 100 mg at Week 2 and then maintenance treatment of 50 mg or 100 mg (weight dependent) every 4 weeks after completion of the induction regimen up to at least Week 12;
OR
ii. History of, or current intolerance (with an initial response), defined as the presence of clinically significant side-effects, including infusion-related hypersensitivity.
d. Vedolizumab:
i. Signs and symptoms of active disease despite a history of at least one induction regimen, defined as at least a 14-week (10 weeks in the EU) induction consisting of 300 mg IV at Weeks 0, 2 and 6.
OR
ii. History of intolerance to vedolizumab including, but not limited to, serious infections, hepatotoxicity, heart failure, allergic reactions, or any other condition that contributed to discontinuation of the agent.
8. Subjects receiving oral corticosteroids for the treatment of UC must be on a stable dose of ≤ 40 mg/day (prednisolone or equivalent), or ≤ 9 mg/day budesonide. This dose must be stable from the initial Screening visit until 1 week after the initiation of study treatment.
9. Subjects receiving oral 5-ASA must be on a stable dose from the initial Screening visit until the end of the study.
10. Subjects willing to cease the use of any therapeutic enema or suppository or foams, other than that required in preparation for study-mandated colonoscopy/flexible sigmoidoscopies, from the initial Screening visit until the end of the study.
11. Subjects willing to cease use of azathioprine or 6-MP from the initial Screening visit until the end of the study.
12. Negative serum pregnancy test in females of childbearing potential at Screening.
13. If female and of childbearing potential, must agree to be sexually abstinent or use one of the following highly effective methods of birth control from the initial Screening visit until 30 days after the last dose of study drug is administered:
1. Hormonal contraceptives (e.g., combined oral contraceptives, patch, vaginal ring, injectables, and implants);
2. Intrauterine contraceptive system;
3. Surgical sterilization or partner sterile (must have documented proof);
AND
One of the following effective methods of birth control:
1. Male/female condom;
2. Cervical cap with spermicide;
3. Diaphragm with spermicide;
4. Contraceptive sponge.
14. Male subjects must be either surgically sterile (must have documented proof), agree to be sexually inactive or use a double-barrier method of birth control (e.g., condom and diaphragm with spermicide, condom with cervical cap and spermicide) from first study drug administration until 90 days after final drug administration.
2. Willing to provide written informed consent and to be compliant with the schedule of study visits and protocol assessments.
3. Diagnosis of UC established at least 3 months prior to the Baseline visit, by clinical and endoscopic evidence (colonoscopy or flexible sigmoidoscopy)
4. Moderately to severely active UC defined as the 3-Component Adapted Mayo Score of 5-9, inclusive, with an endoscopic sub-score of ≥ 2 (from central reading), and a rectal bleeding sub-score of ≥ 1, as determined 10 days (± 3 days) prior to Baseline.
5. Evidence of active UC, confirmed histologically (from local read), extending proximal to the rectum with ≥ 15 cm of involved colon.
6. At Screening, a colonoscopy will be required if the subject has had extensive colitis or pancolitis of \> 8 years duration or left-sided colitis of \> 12 years duration but has not had a colonoscopy within 1 year of the initial screening date. If the subject has had a colonoscopy within 1 year of the initial screening date, a flexible sigmoidoscopy may be used.
7. Subjects presenting at Screening with moderately to severely active UC demonstrating an inadequate response or loss of response or intolerance/medical contraindication to at least one of the following conventional therapies for UC:
a. Corticosteroids:
i. Signs and symptoms of active disease despite treatment with an adequate dose (e.g., prednisolone \> 40 mg/day or equivalent) over a period of 4 weeks for oral therapy or intravenously (IV) for up to 1 week or ≥ 9 mg/day oral budesonide;
OR
ii. Unable to reduce corticosteroids below the equivalent of prednisolone 10 mg daily orally within 3 months of starting steroids or having experienced a relapse within 3 months of stopping steroids;
OR
iii. History of, or current intolerance to corticosteroids (including, but not limited to Cushing's syndrome, osteopenia/osteoporosis, hyperglycemia, insomnia, infection).
b. Immunomodulators:
i. Signs and symptoms of active disease despite at least 3 months of treatment with a sufficient dose (oral azathioprine ≥ 1.5 mg/kg or 6-mercaptopurine \[6-MP\] ≥ 0.75 mg/kg);
OR
ii. History of, or current dose-limiting toxicity associated with use of the agent (e.g., but not limited to nausea/vomiting, abdominal pain, pancreatitis, liver function test \[LFT\] abnormalities, lymphopenia, TPMT genetic mutation, infection).
c. Anti-tumor necrosis factor (anti-TNF) agents:
i. Signs and symptoms of active disease despite treatment with a single anti-TNF agent. Treatment failure is defined as a relapse after an initial response to therapy as follows:
* Infliximab: At least 4 infusions of at least 5 mg/kg within a 14-week timeframe for induction and maintenance;
* Adalimumab: Induction regimen incorporating 160 mg at Week 0 (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days) and 80 mg at Week 2, followed by maintenance treatment of 40 mg every other week up to at least Week 8;
* Golimumab: Induction regimen incorporating 200 mg subcutaneous (sc) injection at Week 0, followed by 100 mg at Week 2 and then maintenance treatment of 50 mg or 100 mg (weight dependent) every 4 weeks after completion of the induction regimen up to at least Week 12;
OR
ii. History of, or current intolerance (with an initial response), defined as the presence of clinically significant side-effects, including infusion-related hypersensitivity.
d. Vedolizumab:
i. Signs and symptoms of active disease despite a history of at least one induction regimen, defined as at least a 14-week (10 weeks in the EU) induction consisting of 300 mg IV at Weeks 0, 2 and 6.
OR
ii. History of intolerance to vedolizumab including, but not limited to, serious infections, hepatotoxicity, heart failure, allergic reactions, or any other condition that contributed to discontinuation of the agent.
8. Subjects receiving oral corticosteroids for the treatment of UC must be on a stable dose of ≤ 40 mg/day (prednisolone or equivalent), or ≤ 9 mg/day budesonide. This dose must be stable from the initial Screening visit until 1 week after the initiation of study treatment.
9. Subjects receiving oral 5-ASA must be on a stable dose from the initial Screening visit until the end of the study.
10. Subjects willing to cease the use of any therapeutic enema or suppository or foams, other than that required in preparation for study-mandated colonoscopy/flexible sigmoidoscopies, from the initial Screening visit until the end of the study.
11. Subjects willing to cease use of azathioprine or 6-MP from the initial Screening visit until the end of the study.
12. Negative serum pregnancy test in females of childbearing potential at Screening.
13. If female and of childbearing potential, must agree to be sexually abstinent or use one of the following highly effective methods of birth control from the initial Screening visit until 30 days after the last dose of study drug is administered:
1. Hormonal contraceptives (e.g., combined oral contraceptives, patch, vaginal ring, injectables, and implants);
2. Intrauterine contraceptive system;
3. Surgical sterilization or partner sterile (must have documented proof);
AND
One of the following effective methods of birth control:
1. Male/female condom;
2. Cervical cap with spermicide;
3. Diaphragm with spermicide;
4. Contraceptive sponge.
14. Male subjects must be either surgically sterile (must have documented proof), agree to be sexually inactive or use a double-barrier method of birth control (e.g., condom and diaphragm with spermicide, condom with cervical cap and spermicide) from first study drug administration until 90 days after final drug administration.
Exclusion Criteria
If a subject has any of the following criteria, they will be excluded from the study:
1. Subjects without previous treatment for UC.
2. Ulcerative colitis limited to rectum (ulcerative proctitis).
3. Evidence of acute severe colitis with toxic megacolon, abdominal abscess, bowel stricture or bowel perforation.
4. A diagnosis of Crohn's colitis, colitis yet to be classified, ischemic colitis, NSAID-induced colitis, idiopathic colitis (i.e., colitis not consistent with UC) or radiation colitis.
5. Subjects with evidence of pathogenic bowel infection (Clostridium difficile, Escherichia coli, Salmonella, Shigella or Campylobacter).
6. Previous surgery for UC or, in the opinion of the Investigator, will likely require surgery for UC during the study.
7. Any histological evidence of mucosal dysplasia.
8. Subjects with a current or recent history of severe, progressive or uncontrolled cardiac (including uncontrolled hypertension), renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurological (e.g., history of seizures) disease, abnormal magnesium or potassium levels, hypocholesterolemia, or any other severe co-morbidity that, in the opinion of the Investigator, could confound the study results or put the study subject at unreasonable risk.
9. Malignancies or history of malignancy within 5 years of the initial Screening visit, with the exception of adequately treated or excised non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin.
10. Any of the following laboratory abnormalities during the screening period - if values are initially outside the prescribed limits, the evaluation may be repeated once within the screening period to determine eligibility:
1. Hemoglobin level \< 8.0 g/dL
2. Absolute WBC count \< 3.0 × 10\^9/L
3. Absolute Lymphocyte count \< 0.5 × 10\^9/L
4. Absolute neutrophil count \< 1.2 × 10\^9/L
5. Platelet count \< 100 × 10\^9/L or \>1200 × 10\^9/L
6. ALT or AST \> 2.0 × ULN
7. Alkaline phosphatase \> 2.0 × ULN
8. Serum creatinine \> 1.5 × ULN
9. Bilirubin \> 1.5 × ULN
11. Subjects with active TB infection or known history of prior treated or untreated TB infection.
12. Subject with a positive serology test result for HIV (HIV type 1 or type 2).
13. Subject with a positive serology test result for active HBV or HCV infection.
14. Treatment with biologic agents for UC within 56 days or 5 half-lives (whichever is greater) prior to the Baseline visit.
15. Treatment with any calcineurin inhibitor (e.g. cyclosporine or tacrolimus) within 28 days prior to the Baseline visit.
16. Treatment with methotrexate or JAK inhibitors (e.g. tofacitinib) from the initial Screening visit until the end of the study.
17. Initiation of treatment with an oral or IV corticosteroid from the initial Screening visit until the end of the study.
18. Use of any strong inhibitors of CYP enzymes (e.g., cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem, grapefruit juice and HIV antivirals) within 14 days prior to the Baseline visit.
19. Use of strong or moderate P-gp inhibitors (e.g., amiodarone, azithromycin, clarithromycin, itraconazole, ketoconazole, dronedarone, lapatinib, quinidine, ranolazine, verapamil) within 14 days prior to the Baseline visit.
20. Use of any herbal medication for the treatment of UC or which might interfere with CYP enzymes within 14 days prior to the Baseline visit.
21. Subjects vaccinated with a live or live-attenuated vaccine within 14 days of the Baseline visit, or planned vaccination during conduct of the study.
22. Subjects with a QTcF of \> 450 ms for males and \> 470 ms for females at Screening.
23. A history of risk factors for Torsades de pointes (e.g., history of heart failure, hypokalemia, family history of Long QT Syndrome).
24. Known hypersensitivity to cyclosporine or any excipients contained in ST-0529.
25. History of alcohol or drug abuse in the year prior to the initial Screening visit.
26. Subjects currently breast feeding, pregnant, or unwilling to delay initiation of breast feeding for at least 90 days after the last dose of study drug is administered.
27. Participation in another clinical trial and having received investigational medication within 30 days or within 5 half-lives (whichever is longer) prior to the Baseline visit, or concurrent participation in another clinical trial.
28. Subjects who, in the opinion of the Investigator, are unsuitable for inclusion in the study.
1. Subjects without previous treatment for UC.
2. Ulcerative colitis limited to rectum (ulcerative proctitis).
3. Evidence of acute severe colitis with toxic megacolon, abdominal abscess, bowel stricture or bowel perforation.
4. A diagnosis of Crohn's colitis, colitis yet to be classified, ischemic colitis, NSAID-induced colitis, idiopathic colitis (i.e., colitis not consistent with UC) or radiation colitis.
5. Subjects with evidence of pathogenic bowel infection (Clostridium difficile, Escherichia coli, Salmonella, Shigella or Campylobacter).
6. Previous surgery for UC or, in the opinion of the Investigator, will likely require surgery for UC during the study.
7. Any histological evidence of mucosal dysplasia.
8. Subjects with a current or recent history of severe, progressive or uncontrolled cardiac (including uncontrolled hypertension), renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurological (e.g., history of seizures) disease, abnormal magnesium or potassium levels, hypocholesterolemia, or any other severe co-morbidity that, in the opinion of the Investigator, could confound the study results or put the study subject at unreasonable risk.
9. Malignancies or history of malignancy within 5 years of the initial Screening visit, with the exception of adequately treated or excised non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin.
10. Any of the following laboratory abnormalities during the screening period - if values are initially outside the prescribed limits, the evaluation may be repeated once within the screening period to determine eligibility:
1. Hemoglobin level \< 8.0 g/dL
2. Absolute WBC count \< 3.0 × 10\^9/L
3. Absolute Lymphocyte count \< 0.5 × 10\^9/L
4. Absolute neutrophil count \< 1.2 × 10\^9/L
5. Platelet count \< 100 × 10\^9/L or \>1200 × 10\^9/L
6. ALT or AST \> 2.0 × ULN
7. Alkaline phosphatase \> 2.0 × ULN
8. Serum creatinine \> 1.5 × ULN
9. Bilirubin \> 1.5 × ULN
11. Subjects with active TB infection or known history of prior treated or untreated TB infection.
12. Subject with a positive serology test result for HIV (HIV type 1 or type 2).
13. Subject with a positive serology test result for active HBV or HCV infection.
14. Treatment with biologic agents for UC within 56 days or 5 half-lives (whichever is greater) prior to the Baseline visit.
15. Treatment with any calcineurin inhibitor (e.g. cyclosporine or tacrolimus) within 28 days prior to the Baseline visit.
16. Treatment with methotrexate or JAK inhibitors (e.g. tofacitinib) from the initial Screening visit until the end of the study.
17. Initiation of treatment with an oral or IV corticosteroid from the initial Screening visit until the end of the study.
18. Use of any strong inhibitors of CYP enzymes (e.g., cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem, grapefruit juice and HIV antivirals) within 14 days prior to the Baseline visit.
19. Use of strong or moderate P-gp inhibitors (e.g., amiodarone, azithromycin, clarithromycin, itraconazole, ketoconazole, dronedarone, lapatinib, quinidine, ranolazine, verapamil) within 14 days prior to the Baseline visit.
20. Use of any herbal medication for the treatment of UC or which might interfere with CYP enzymes within 14 days prior to the Baseline visit.
21. Subjects vaccinated with a live or live-attenuated vaccine within 14 days of the Baseline visit, or planned vaccination during conduct of the study.
22. Subjects with a QTcF of \> 450 ms for males and \> 470 ms for females at Screening.
23. A history of risk factors for Torsades de pointes (e.g., history of heart failure, hypokalemia, family history of Long QT Syndrome).
24. Known hypersensitivity to cyclosporine or any excipients contained in ST-0529.
25. History of alcohol or drug abuse in the year prior to the initial Screening visit.
26. Subjects currently breast feeding, pregnant, or unwilling to delay initiation of breast feeding for at least 90 days after the last dose of study drug is administered.
27. Participation in another clinical trial and having received investigational medication within 30 days or within 5 half-lives (whichever is longer) prior to the Baseline visit, or concurrent participation in another clinical trial.
28. Subjects who, in the opinion of the Investigator, are unsuitable for inclusion in the study.
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Dr. Falk Pharma GmbH
INDUSTRY
Sponsor Role
collaborator
Sublimity Therapeutics Holdco Limited
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Sponsor Responsible Medical Officer
Role: STUDY_DIRECTOR
Sublimity Therapeutics (HoldCo) Ltd
Locations
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Palmtree Clinical Research Inc
Palm Springs, California, United States
Site Status
Advanced Research Institute
Largo, Florida, United States
Site Status
Advanced Research Institute, Inc.
New Port Richey, Florida, United States
Site Status
Endoscopic Research Inc
Orlando, Florida, United States
Site Status
University of Chicago
Chicago, Illinois, United States
Site Status
AGA Clinical Reasearch Associates, LLC
Egg Harbor, New Jersey, United States
Site Status
Baylor College of Medicine
Houston, Texas, United States
Site Status
Biopharma Informatic, LLC.
Houston, Texas, United States
Site Status
Grodno Regional Clinical Hospital
Grodno, , Belarus
Site Status
Gomel Regional Clinical Hospital
Homyel, , Belarus
Site Status
City Clinical Emergency Hospital
Minsk, , Belarus
Site Status
MedConsult Pleven
Pleven, , Bulgaria
Site Status
Medical Center Asklepion
Sofia, , Bulgaria
Site Status
UMBAL Tsaritsa Joanna ISUL
Sofia, , Bulgaria
Site Status
Dalhousie University - Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Site Status
London Health Sciences Centre
London, Ontario, Canada
Site Status
CHU Amiens Picardie - Service Hépato-Gastroentérologie
Amiens, , France
Site Status
CHU DE MONTPELLIER - Hôpital St ELOI
Montpellier, , France
Site Status
CHU de Saint-Etienne - Service de Gastro-Entérologie-Hépatologie
Saint-Etienne, , France
Site Status
Hôpital de Brabois Service d'Hépato-Gastro-Entérologie
Vandœuvre-lès-Nancy, , France
Site Status
Eugastro GmbH
Leipzig, Saxony, Germany
Site Status
Medizinische Klinik für Gastroenterologie, Infektiologie, Rheumatologie charite
Berlin, , Germany
Site Status
Krankenhaus Walfriede, Akademisches Lehrkrankenhaus der Charite
Berlin, , Germany
Site Status
Klinik für Gastroenterologie, Pulmologie und allg. lnnere Medizin
Cologne, , Germany
Site Status
Agaplesion Markus Krankenhaus Medizinischen Klinik I, Gastroenterologie, Hepatologie, Onkologie, lnfektiologie
Frankfurt, , Germany
Site Status
Universitatsklinikum Freiburg, Medizinische Klinik
Freiburg im Breisgau, , Germany
Site Status
Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Zentrym für Innere Medizin
Hanover, , Germany
Site Status
Universität Leipzig, Klinik f. Gastroenterologie und Rheumatologie
Leipzig, , Germany
Site Status
Gastroenterologische Gemeinschaftspraxis Minden
Minden, , Germany
Site Status
DRC Gyógyszervizsgáló Központ Kft.
Balatonfüred, , Hungary
Site Status
Semmelweis University
Budapest, , Hungary
Site Status
Semmelweis University, AOK Varosmajori Sziv- es Ergyogyaszati Klinika,
Budapest, , Hungary
Site Status
Bugat Pal Hospital
Gyöngyös, , Hungary
Site Status
Mater Misericordiae University Hospital
Dublin, , Ireland
Site Status
St. James's Hospital
Dublin, , Ireland
Site Status
Gastroenterology Institute, Emek Medical Center
Afula, , Israel
Site Status
Barzilai Medical Center
Ashkelon, , Israel
Site Status
Clalit Health Services Jerusalem
Jerusalem, , Israel
Site Status
Institute of Gastroenterology, Meir Medical Center
Kfar Saba, , Israel
Site Status
Humanitas Research Hospital, IBD Center
Milan, , Italy
Site Status
A.0.U. di Modena - Policlinico S.C. di Gastroenterologia
Modena, , Italy
Site Status
Fondazione IRCCS Policlinico San Matteo - Medicina Generale I
Pavia, , Italy
Site Status
ASST Rhodense - Ospedale di Rho
Rho, , Italy
Site Status
Fondazione Casa Sollievo della Sofferenza
San Giovanni Rotondo, , Italy
Site Status
Centrum Opieki Zdrowotnej Orkan-med
Ksawerów, , Poland
Site Status
Oddział Kliniczny Gastroenterologii Ogólnej i Onkologicznej SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego UM
Lodz, , Poland
Site Status
Medicome Sp. z o.o.
Oświęcim, , Poland
Site Status
Centrum Medyczne Medyk
Rzeszów, , Poland
Site Status
Endoskopia sp. z o.o.
Sopot, , Poland
Site Status
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, , Poland
Site Status
MedLife Grivita
Bucharest, , Romania
Site Status
Colentina Clinical Hospital
Bucharest, , Romania
Site Status
University Hospital Bucharest
Bucharest, , Romania
Site Status
Federal State Center of Coloproctology
Moscow, , Russia
Site Status
LLC Medical center Healthy family
Novosibirsk, , Russia
Site Status
Military Medical Academy
Saint Petersburg, , Russia
Site Status
North-Western State Medical University n.a. I.I.Mechnikov
Saint Petersburg, , Russia
Site Status
Saint-Petersburg State Medical Academy n.a. I.I. Mechnikov of Federal Agency of Healthcare & Social Development
Saint Petersburg, , Russia
Site Status
Scientific Research Center Eco-Safety LLC
Saint Petersburg, , Russia
Site Status
Pavlov First Saint Petersburg State Medical University
Saint Petersburg, , Russia
Site Status
Non state Public Health Institution "Railway clinical hospital on station Samara" of joint stock company Russian railways
Samara, , Russia
Site Status
Saratov State Medical University
Saratov, , Russia
Site Status
Siberia State Medical University
Tomsk, , Russia
Site Status
Clinical Center Zvezdara
Belgrade, , Serbia
Site Status
Clinical Hospital Center "Dr Dragisa Misovic-Dedinje"
Belgrade, , Serbia
Site Status
Clinical-Hospital Centre Bezanijska Kosa - Gastroenterology Department
Belgrade, , Serbia
Site Status
Clinical Center Kragujevac
Kragujevac, , Serbia
Site Status
Hospital Universitario Virgen de la Macarena
Seville, , Spain
Site Status
Chernivtsi Regional Clinical Hospital
Chernivtsi, , Ukraine
Site Status
Ivano-Frankivsk National Medical University, Regional Clinical Hospital
Ivano-Frankivsk, , Ukraine
Site Status
Kharkiv City Clinical Hospital No 2 n.a. prof. O.O.Shalimov
Kharkiv, , Ukraine
Site Status
Kiev City Clinical Hospital No. 1
Kiev, , Ukraine
Site Status
Communal Institution of Kyiv Regional Council "Kyiv Regional Clinical Hospital"
Kyiv, , Ukraine
Site Status
Ukrainian-German Gastroenterology Center "BYK-Kyiv"
Kyiv, , Ukraine
Site Status
Volyn Regional Clinical Hospital
Lutsk, , Ukraine
Site Status
Communal Nonprofit Enterprise "Lviv Clinical Emergency Care Hospital"
Lviv, , Ukraine
Site Status
Communal Nonprofit Entreprise, "Lviv Clinical Emergency Care Hospital", 1st Therapeutic Dpt
Lviv, , Ukraine
Site Status
Communal Nonprofit Enterprise "Odesa Regional Clinical Hospital"
Odesa, , Ukraine
Site Status
Communal Nonprofit Enterprise "Ternopil University Hospital" of Ternopil Regional Council
Ternopil, , Ukraine
Site Status
Municipal Institution "Uzhhorod Central District Hospital"
Uzhhorod, , Ukraine
Site Status
Medical Center "Health Clinic"
Vinnytsia, , Ukraine
Site Status
Communal Non-profit Enterprise "Vinnytsia City Clinical Hospital #1"
Vinnytsia, , Ukraine
Site Status
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom
Site Status
South Eastern Health & Social Care Trust, Ulster Hospital
Belfast, Co Antrim, United Kingdom
Site Status
Royal Liverpool & Broadgreen University Hospitals NHS Trust
Liverpool, Merseyside, United Kingdom
Site Status
Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust
Birmingham, Warwickshire, United Kingdom
Site Status
Barnsley Hospital NHS Foundation Trust
Barnsley, Yorkshire, United Kingdom
Site Status
University College London Hospital NHS Foundation Trust
London, , United Kingdom
Site Status
King's College Hospital NHS Foundation Trust
London, , United Kingdom
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
Belarus
Bulgaria
Canada
France
Germany
Hungary
Ireland
Israel
Italy
Poland
Romania
Russia
Serbia
Spain
Ukraine
United Kingdom
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CYC-202
Identifier Type: -
Identifier Source: org_study_id
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