A Phase 2 Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HRS-7085 Tablets in Patients With Inflammatory Bowel Disease
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 2
Contacts and Locations
Study Contact
Study Contact
- Name: Tingyu Dong
- Phone Number: 0518-82342973
- Email: tingyu.dong@hengrui.com
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 610044
- Recruiting
- West China Hospital of Sichuan University
-
Principal Investigator:
- Yufang Wang
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male and female subject age ≥ 18,≤75.
- the body mass index (BMI= weight (kg)/height (2 m ²)) of the subjects is ≥ 18 kg/m ².
- Subject has active Ulcerative Colitis with a 9-point modified Mayo score of 4-9 at baseline, with an endoscopic subscore of ≥ 2 (confirmed by central read), and rectal bleeding subscore of ≥1.
- Subject has at least a 90-days history of Ulcerative Colitis diagnosis at baseline.
- Subject is deemed by the physician as having inadequate response, loss of response or intolerance to at least one conventional treatment (oral 5-ASA, immunosuppressants or corticosteroids), or anti-TNF therapy (e.g., infliximab, adalimumab) or other biological, or JAK inhibitors treatment.
- Subject is capable of providing a signed and dated informed consent form indicating the subject has been informed of all pertinent aspects of the study.
- All women of childbearing potential and their male partners must commit to using a highly effective contraception to 3 months after last dose of study medication.
Exclusion Criteria:
- Subject has a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's Disease.
- Subject with Ulcerative Colitis, which is confined to a proctitis (distal 15 cm or less).
- Treatment naïve subject diagnosed with Ulcerative Colitis.
- Subject is displaying clinical signs of ischemic colitis, fulminant colitis or toxic megacolon.
- Subject had previous surgery as a treatment for Ulcerative Colitis or likely to require surgery during the study period.
- Screening endoscopic examination revealed that the subjects had a history of gastrointestinal dysplasia (atypical hyperplasia)/cancer or dysplasia (atypical hyperplasia)/cancer. Except for completely resected low-grade dysplasia.
- Subject has evidence of pathogenic bowel infection. Subjects had Clostridium difficile or other intestinal infection within 30 days of screening endoscopy or test positive at screening for C. difficile toxin or other intestinal pathogens.
Subject currently has or had:
8.1 A clinically significant infection within 1 month of baseline. 8.2 A history of more than one episode of herpes zoster, or disseminated zoster (single episode).
8.3 Any infection otherwise judged by the investigator to have the potential for exacerbation by participation in the study.
8.4Any infection requiring antimicrobial therapy within 2 weeks of screening.
- Subject is receiving any of the following therapies:
9.1 Cyclosporine, mycophenolate, tacrolimus、JAK inhibitors within 4 weeks prior to baseline.
9.2 Interferon therapy within 8 weeks prior to baseline. 9.3 Intravenous corticosteroids or rectally administered formulation of corticosteroids or 5-ASA within 2 weeks prior to baseline.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Treatment group A: HRS-7085 Low dose
|
HRS-7085 Low dose po
HRS-7085 High dose po
|
|
Experimental: Treatment group B: HRS-7085 High dose
|
HRS-7085 Low dose po
HRS-7085 High dose po
|
|
Placebo Comparator: Treatment group C: Placebo
|
Placebo po
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Proportion of subjects experiencing at least one Adverse Event
Time Frame: at Week 14
|
at Week 14
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Peak Plasma Concentrations (Cmax)
Time Frame: at Week 4
|
at Week 4
|
|
Area Under the Curve (AUC) of Plasma Concentrations
Time Frame: at Week 4
|
at Week 4
|
|
Proportion of subjects achieving clinical response
Time Frame: at Week 8
|
at Week 8
|
|
Proportion of subjects achieving symptomatic remission,
Time Frame: at Week 8
|
at Week 8
|
|
Proportion of subjects achieving clinical remission
Time Frame: at Week 8
|
at Week 8
|
|
Change from baseline in partial Mayo score,
Time Frame: at week8、week12
|
at week8、week12
|
|
Change from baseline in EQ-5D-5L (5-Level EuroQol 5-Dimension) index score,
Time Frame: at Week 8
|
at Week 8
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- HRS-7085-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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