Adult Patients With Moderately to Severely Active Ulcerative ColitisPhase 2NCT07229950
A Phase 2 Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HRS-7085 Tablets in Patients With Inflammatory Bowel Disease
A Phase 2 study testing HRS-7085 in people with Adult Patients With Moderately to Severely Active Ulcerative Colitis, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
This study is a randomized, double-blind, placebo-controlled Phase II clinical trial comprising screening period, treatment period, and follow-up period. This phase 2 study is being conducted to evaluate the efficacy, safety and pharmacokinetics of HRS-7085 in patients with moderate to severe active ulcerative colitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adult Patients With Moderately to Severely Active Ulcerative Colitis
- What is being tested?
- HRS-7085
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 17 Oct 2025to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610044
Yufang Wang
About this study
This study is a randomized, double-blind, placebo-controlled Phase II clinical trial comprising screening period, treatment period, and follow-up period. This phase 2 study is being conducted to evaluate the efficacy, safety and pharmacokinetics of HRS-7085 in patients with moderate to severe active ulcerative colitis.
- Being tested
- HRS-7085, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-7085Drug
HRS-7085 Low dose po
HRS-7085Drug
HRS-7085 High dose po
PlaceboDrug
Placebo po
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: HRS-7085 Low dose | Experimental | Not described Receives: Drug: HRS-7085 |
| Treatment group B: HRS-7085 High dose | Experimental | Not described Receives: Drug: HRS-7085 |
| Treatment group C: Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects experiencing at least one Adverse Event
Measured: at Week 14
Secondary outcomes (7)
Proportion of subjects achieving clinical response
Measured: at Week 8
Proportion of subjects achieving symptomatic remission,
Measured: at Week 8
Proportion of subjects achieving clinical remission
Measured: at Week 8
Change from baseline in partial Mayo score,
Measured: at week8、week12
Change from baseline in EQ-5D-5L (5-Level EuroQol 5-Dimension) index score,
Measured: at Week 8
Peak Plasma Concentrations (Cmax)
Measured: at Week 4
Area Under the Curve (AUC) of Plasma Concentrations
Measured: at Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start17 Oct 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Patients With Moderately to Severely Active Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229950
- Sponsor's protocol ID
- HRS-7085-201
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HRS-7085 Tablets in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT07229950
- Acronym / sponsor ID
- HRS-7085-201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Oct 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized, double-blind, placebo-controlled Phase II clinical trial comprising screening period, treatment period, and follow-up period. This phase 2 study is being conducted to evaluate the efficacy, safety and pharmacokinetics of HRS-7085 in patients with moderate to severe active ulcerative colitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: HRS-7085 Low dose | Experimental | Drug: HRS-7085 |
| Treatment group B: HRS-7085 High dose | Experimental | Drug: HRS-7085 |
| Treatment group C: Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-7085HRS-7085 Low dose po | Drug | Treatment group A: HRS-7085 Low dose |
| HRS-7085HRS-7085 High dose po | Drug | Treatment group B: HRS-7085 High dose |
| PlaceboPlacebo po | Drug | Treatment group C: Placebo |
Primary outcome
Proportion of subjects experiencing at least one Adverse Event
Time frame: at Week 14
7 secondary outcomes
Proportion of subjects achieving clinical response
Time frame: at Week 8
Proportion of subjects achieving symptomatic remission,
Time frame: at Week 8
Proportion of subjects achieving clinical remission
Time frame: at Week 8
Change from baseline in partial Mayo score,
Time frame: at week8、week12
Change from baseline in EQ-5D-5L (5-Level EuroQol 5-Dimension) index score,
Time frame: at Week 8
Peak Plasma Concentrations (Cmax)
Time frame: at Week 4
Area Under the Curve (AUC) of Plasma Concentrations
Time frame: at Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRS-7085 in people with Adult Patients With Moderately to Severely Active Ulcerative Colitis, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tingyu Dong (0518-82342973, tingyu.dong@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects experiencing at least one Adverse Event (time frame: at Week 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.