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

• Register: EUCTR
• Last refreshed on: 30 April 2019
• Main ID: EUCTR2015-001022-42-IT
• Date of registration: 29/03/2019
• Prospective Registration: No
• Primary sponsor: Holy Stone Healthcare Co., Ltd.
• Public 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
• Scientific 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
• Date of first enrolment: 01/12/2015
• Target sample size: 51
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001022-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Italy

Contacts

• Name: Clinical Trials Information
• Affiliation: Holy Stone Biotech Co., Ltd.

• Name: Clinical Trials Information
• Affiliation: Holy Stone Biotech Co., Ltd.

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female, age =18 and <75 years, suffering from UC for at least 6 months prior to screening.
2. If the patient is a female, she is eligible to enter the study if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who has undergone sterilization [hysterectomy or bilateral tubal ligation] or is post-menopausal. For purposes of this study, postmenopausal is defined as 1 year without menses).
OR
If she is of childbearing potential, she is eligible to enter the study if she has a negative serum pregnancy test at screening and, one of the following:
a) Agrees to use hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, implants, intrauterine hormone-releasing system (IUS), intrauterine device (IUD) inserted by a qualified clinician with published data showing that the lowest expected failure rate is less than or equal to 1% per year (not all IUDs meet this criterion), for the duration of the study, plus a further 90-day period. The Investigator will be responsible for determining whether the patient is using appropriate birth control method for study participation.
b) Has a vasectomized partner (provided that partner is the sole sexual partner and that the vasectomized partner has received medical assessment of the surgical success), or the partner agrees to use medically acceptable and highly effective method of contraception such as double barrier method of contraception, specifically, use of a condom and spermicide throughout the study period and 90-day period after the study.
c) For non-sexually active females, abstinence may be regarded as an adequate method of birth control only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. However, if the patient becomes heterosexually active during the study treatment period, she must agree to use adequate birth control methods as defined above for the remainder of the study treatment period.
3. If the patient is a male, he is eligible to enter the study if he is vasectomized or agrees to use medically acceptable and highly effective method of contraception such as double barrier method of contraception, specifically, use of condom and spermicide throughout the study period and 90-day period after the study.
4. Diagnosis of active UC with modified UCDAI =4 and =10, with endoscopy score of =1 in the modified UCDAI mucosal appearance subscore.
5. Patients with either newly diagnosed or relapsed UC (onset of current episode of relapse must be within 6 weeks prior to screening). 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 visit.
6. Patients must have up-to-date surveillance colonoscopy for malignancy, per treatment guideline.
7. Willing and able to provide signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-
Exclusion criteria:
Patients meeting any of the following criteria are ineligible to participate in this study:
1. Patients diagnosed with Crohn’s disease, indeterminate colitis, ischaemic colitis, or active gastric or active duodenal ulcers.
2. Female patients who are pregnant or breastfeeding
3. Ulcerative proctitis with =15 cm of disease
4. 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
5. History of or current evidence of toxic megacolon, fulminant colitis (e.g., Lichtiger score of =10), colonic perforation
6. Any previous colonic surgery (except appendectomy) or short bowel syndrome
7. Patients who required doses of mesalamine higher than 2.4 g/day for maintenance.
8. Hypersensitivity to salicylates/aspirin
9. Use of the following medications:
a - Use of oral or rectal 5 aminosalicylic (5-ASA) within 11 days prior to randomization.
b - Use of systemic or rectal corticosteroid within 4 weeks prior to or during screening.
c - Use of anti-tumor necrosis factor-alpha (anti TNF-a) agents or other biologics such as vedolizumab within 90 days prior to or during screening.
d - Use of immunosuppressants (e.g., azathioprine, mercaptopurine) within 6 weeks prior to or during screening.
e - Use of antibiotics for UC within 7 days prior to or during screening.
10. Clinically significantly abnormal ECG at screening
11. Liver cirrhosis or alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels >2 times the upper limit of normal (ULN)
12. Serum creatinine >2X ULN
13. Known history of drug or alcohol abuse within the last 3 years prior to screening
14. Participation in another clinical trial involving an investigational agent within 3 months prior to screening (Visit 1). Patients cannot participate in any other investigational medication or medical device trial while participating in this study (participation in a registry or observational study without an additional therapeutic intervention is allowed)
15. Any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the Investigator, would confound the study results or compromise patient safety
16. Had any surgical procedure requiring general anesthesia within 30 days prior to screening or is planning to undergo major surgery during the study period
17. Any active malignancy within the last 5 years, except for basal cell carcinoma of the skin, or if female, in situ cervical carcinoma that has been surgically excised
18. Patient has a history of hepatitis B or C (HVB or HVC) or human immunodeficiency virus (HIV). HVB-HVC positive is defined as positive hepatitis B surface antigen (HBsAg), total hepatitis B core antibody (HBcAb; also referred to as anti-HBc), and/or hepatitis C antibody (HCVAb) with confirmation by hepatitis C virus ribonucleic acid (HCV RNA). For HIV, pa

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Active, Mild to Moderate Ulcerative Colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Product Name: IBD98-M Delayed-release Capsules
Product Code: IBD98-M
Pharmaceutical Form: Capsule
INN or Proposed INN: SODIUM HYALURONATE
CAS Number: 9067-32-7
Other descriptive name: SODIUM HYALURONATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 23-
INN or Proposed INN: MESALAZINE
CAS Number: 89-57-6
Other descriptive name: Mesalamine, 5-ASA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: To compare the percentage of patients in UC remission at Week 6 for each of the 2 IBD98-M dose groups versus placebo (remission defined as the modified Ulcerative Colitis Disease Activity Index [UCDAI] score of =1, with a score of 0 for rectal bleeding and stool frequency, no mucosal friability, and sigmoidoscopy score not exceeding 1)

Secondary Objective: Secondary Objectives
? To compare clinical improvement rates at Week 6 among treatment groups (defined as a =3 point reduction from baseline in the modified UCDAI score)
?To compare endoscopic improvement at Week 6 among treatment groups (defined as a =1 point decrease in modified UCDAI mucosal appearance subscore)
? To determine the change in symptoms (rectal bleeding and stool frequency) from baseline to each study visit among treatment groups
? To evaluate the safety and tolerability profile of IBD98-M

Timepoint(s) of evaluation of this end point: Week 6

Primary end point(s): ? Percentage of patients in remission at Week 6
Remission as defined by modified UCDAI score of =1, with a score of 0 for rectal bleeding and stool frequency, no mucosal friability, and sigmoidoscopy score not exceeding 1.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Timepoints for secondary efficacy endpoints are as follows:

• Proportion of patients with clinical improvement at Week 6 (defined as a =3 point reduction from baseline in the modified UCDAI score)
• Proportion of patients with endoscopic improvement at Week 6 (defined as a =1 point decrease in modified UCDAI mucosal appearance subscore)
• Change in symptoms (rectal bleeding and stool frequency) from baseline to each study visit

Secondary end point(s): The secondary efficacy endpoints are as follows:
• Proportion of patients with clinical improvement at Week 6 (defined as a =3 point reduction from baseline in the modified UCDAI score)
• Proportion of patients with endoscopic improvement at Week 6 (defined as a =1 point decrease in modified UCDAI mucosal appearance subscore)
• Change in symptoms (rectal bleeding and stool frequency) from baseline to each study visit
The safety endpoints are as follows:
• Incidence and severity of all TEAEs
• Incidence and severity of SAEs
• Systemic tolerance (physical examination, vital signs, electrocardiograms [ECGs], and laboratory assessments of safety parameters)

Secondary ID(s)

IBD98-M-2002

Source(s) of Monetary Support

Holy Stone Healthcare Co., Ltd.

Ethics review

Status: Approved
Approval date:
Contact: