A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M
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| ClinicalTrials.gov Identifier: NCT02493712 |
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Recruitment Status :
Completed
First Posted : July 9, 2015
Results First Posted : August 14, 2020
Last Update Posted : August 14, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Colitis, Ulcerative | Drug: High dose Drug: Low dose Drug: Placebo | Phase 2 |
Study IBD98-M-2002 is a Phase 2a, multicenter, randomized, double-blind, parallel-group, placebo-controlled study in patients with active, mild to moderate UC. It is being conducted as an exploratory proof of concept study to investigate the clinical efficacy of IBD98-M delayed-release capsules (in a fixed combination) over a 6-week treatment period and a 2-week follow-up period.
Patients will be screened for study enrollment up to 4 weeks prior to randomization (Visit 3). During the screening period, patients will be evaluated by conducting laboratory tests, physical examination, and sigmoidoscopy. To be eligible, patients are to have a score of ≥4 and ≤10 on the UCDAI, and a score of ≥1 on the UCDAI endoscopy subscore. In addition, the diagnosis of UC must be confirmed by endoscopic and histologic evidence in the past; if prior confirmation is not available, this must be done at the time of screening endoscopy. After the screening visits, eligible patients will be randomized to 1 of 3 study groups: (1) IBD98 M 0.8 g/day (mesalamine 0.8 g with sodium hyaluronate 92 mg), (2) IBD98 M 1.2 g/day (mesalamine 1.2 g with sodium hyaluronate 138 mg), or (3) placebo. Up to 51 patients will be enrolled in this study (including drop-out patients), with 17 patients randomized to each treatment group. Patients will be encouraged to take their medication at the same time every day.
During the study, patients will visit the clinic on 7 occasions: 2 visits during the screening period (the second screening visit is the baseline visit); 4 visits during the treatment period, Visits 3, 4, 5, and 6/early termination at Weeks 0, 2, 4, and 6; and 1 visit at the end of the follow-up period, Visit 7 at Week 8. Patients will record the dates/times of dosing (after randomization), concomitant medication, and symptoms and adverse events (AEs) in a daily diary starting at Visit 1 and continuing until the end of treatment (Visit 6/early termination). Rescue medication will not be permitted during the 6 weeks of the treatment period, and patients who are considered to not be benefiting from the therapy can be withdrawn and assigned an appropriate alternative UC treatment by the Investigator. Compliance will be assessed throughout the study by determining the amount of unused medication. Records will be kept of all medication dispensed, used, and returned by each patient. At the end of the study, all unused trial medication and used packaging will be returned to the Sponsor. All study medication will be accounted for and any discrepancies documented.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 51 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M Delayed-release Capsules to Induce Remission in Patients With Active, Mild to Moderate Ulcerative Colitis |
| Study Start Date : | January 2016 |
| Actual Primary Completion Date : | July 2018 |
| Actual Study Completion Date : | April 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: High dose
High dose, twice a day for 6 weeks.
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Drug: High dose
6 capsules of IBD98-M, twice a day
Other Name: Mesalamine-Sodium Hyaluronic 200 mg-23 mg |
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Placebo Comparator: Placebo: C
Placebo, twice a day
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Drug: Placebo
Placebo |
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Experimental: Low dose
Low dose, twice a day for 6 weeks
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Drug: Low dose
4 capsules of IBD98-M
Other Name: Mesalamine-Sodium Hyaluronic 200 mg-23 mg |
- Remission Rate [ Time Frame: 6 weeks ]
Percentage of patients in remission over a 6-week treatment period. Remission is defined as a modified UCDAI (Ulcerative Colitis Disease Activity Index) score of ≤1, with a score of 0 for rectal bleeding and stool frequency, no mucosal friability, and sigmoidoscopy score not exceeding 1).
Modified UCDAI scoring system is sum of following 4 subscores (parameters). Higher score means worst disease condition.
Rectal bleeding: score 1 (Streaks of blood), score 2 (obvious blood), score 3 (Mostly Blood) Stool frequency: score 1 (1-2/day> normal), score 2 (3-4/day >normal), score 3 (>4/day> normal) Mucosal appearance: score 1 (Erythema, decreased vascular pattern, Minimal granularity), score 2 (Marked erythema, Friability, Granularity, Absent vascular pattern, Bleeding minimal trauma, No ulcerations), score 3 (Ulceration Spontaneous bleeding) Physician's Global Assessment: score 1 (mild), score 2 (Moderate), score 3 (Severe)
- Improvement Rate [ Time Frame: 6 weeks ]
Clinical improvement over a 6-weeks treatment period was defined as a ≥ 3 point reduction from Baseline in the modified UCDAI (Ulcerative Colitis Disease Activity Index ) score.
Modified UCDAI scoring system is sum of following 4 subscores (parameters). Higher score means worst disease condition.
Rectal bleeding: score 1 (Streaks of blood), score 2 (obvious blood), score 3 (Mostly Blood) Stool frequency: score 1 (1-2/day> normal), score 2 (3-4/day >normal), score 3 (>4/day> normal) Mucosal appearance: score 1 (Erythema, decrased vascular pattern, Minimal granularity), score 2 (Marked erythema, Friability, Granularity, Absent vascular pattern, Bleeding minimal trauma, No ulcerations), score 3 (Ulceration Spontaneous bleeding) Physician's Global Assessment: score 1 (mild), score 2 (Moderate), score 3 (Severe)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female, age ≥18 and <75 years, suffering from UC for at least 6 months prior to screening
- Female patients must be postmenopausal, sterile, or have a negative urine pregnancy test prior to entering the study and use adequate contraception during the study if of childbearing potential.
- Diagnosis of active UC with UCDAI ≥4 and ≤10, with endoscopy score of ≥1 in the UCDAI mucosal appearance subscore
Exclusion Criteria:
- Patients diagnosed with Crohn's disease, indeterminate colitis, or ischemic colitis
- Female patients who are pregnant or breastfeeding
- Ulcerative proctitis with ≤15 cm of disease
- Patients with infectious colitis as determined by assessment for Clostridium difficile (C. difficile) and fecal pathogens at screening or treatment for C. difficile within 30 days prior to screening
- History of or current evidence of toxic megacolon, fulminant colitis (e.g., Lichtiger score of ≥10), colonic perforation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02493712
| Italy | |
| Istituto Clinico Humanitas | |
| Milan, Italy | |
| Principal Investigator: | Silvio Danese | Istituto Clinico Humanitas |
Documents provided by Holy Stone Healthcare Co., Ltd:
| Responsible Party: | Holy Stone Healthcare Co., Ltd |
| ClinicalTrials.gov Identifier: | NCT02493712 |
| Other Study ID Numbers: |
IBD98-M-2002 |
| First Posted: | July 9, 2015 Key Record Dates |
| Results First Posted: | August 14, 2020 |
| Last Update Posted: | August 14, 2020 |
| Last Verified: | August 2020 |
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Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases |
Mesalamine Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents |