Mild to Moderate Ulcerative ColitisPhase 2NCT05770609
A Study of SPH3127 in the Treatment of Mild to Moderate Ulcerative Colitis
A Phase 2 study testing SPH3127 Tablets with Dose A and SPH3127 Tablets with Dose B in people with Mild to Moderate Ulcerative Colitis, run by Shanghai Pharmaceuticals Holding Co., Ltd at 25 sites in China.
Trial summary
To preliminarily evaluate the clinical efficacy of the renin inhibitor SPH3127 Tablets in patients with mild to moderate ulcerative colitis with placebo as a control and determine the recommended dose. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mild to Moderate Ulcerative Colitis
- What is being tested?
- SPH3127 Tablets with Dose A and SPH3127 Tablets with Dose B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 25 sitesChina
- Study dates
- 19 Jun 2023to 13 Sep 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Aged 18 - 75 years, male or female;
- Subjects who have been diagnosed with ulcerative colitis；
- Subjects who agree to take effective contraceptive measures with their spouses throughout the study period and for up to 12 weeks after the last dose;
- Subjects who thoroughly learn about the nature, significance, possible benefits, possible inconvenience and potential risks of the trial, understand the study procedures and voluntarily sign the informed consent form prior to their participation in the trial.
Who cannot join
- Subjects who are diagnosed with Crohn's disease or indeterminate colitis;
- Subjects with active infections at screening which may, as evaluated by the investigator, cause increased risks for subjects;
- Subjects who had surgery that might impact the absorption of oral drugs, subjects who will undergo surgery during the study period, subjects who have undergone major surgery before screening, or subjects who have a plan of surgery during the study period;
- Subjects and lactating women and those who will become pregnant within 6 months after the trial starts;
- Subjects with a history of drug abuse with clinical significance within 1 year prior to screening;
- Subjects with other diseases or conditions that the investigator considers unsuitable for this trial.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
China25 sites
Affiliated Hospital of Hebei University
Baoding, Hebei
Beijing Chao-Yang Hospital,Capital Medical University
Beijing, 100020
Peking University Third Hospital
Beijing
The First Hospital of Hunan University of Chinese Medicine
Changsha, Hunan
Chifeng Municipal Hospital
Chifeng
The First Affiliated Hospital，Sun Yat-sen University
Guangzhou, Guangdong, 510080
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
Nanfang Hospital, Southern Medical University
Guangzhou, Guanmgdong
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, 310003
The First Affiliated Hospital of University of South China
Hengyang, Hunan, 675299
Huizhou First Hospital
Huizhou, Guangdong
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong
The First Affiliated Hospital of Henan University
Kaifeng, Henan
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, 200001
Shengjing Hospital affiliated to China Medical University
Shenyang, Liaoning, 110136
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei
Suining Central Hospital
Suining, Sichuan
Tianjin Medical University General Hospital;
Tianjin, 300052
Union Hospital Tongji Medical College Huazhong Universitu of Science and Technology
Wuhan, Hubei, 430000
Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Xi'an Central Hospital
Xi’an, Shanxi
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, He'nan
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Dose-finding Phase II Clinical Study to Evaluate the Efficacy and Safety of SPH3127 Tablets in the Treatment of Mild to Moderate Ulcerative Colitis
To preliminarily evaluate the clinical efficacy of the renin inhibitor SPH3127 Tablets in patients with mild to moderate ulcerative colitis with placebo as a control and determine the recommended dose.
- Conditions
- Mild to Moderate Ulcerative Colitis
- Being tested
- SPH3127 Tablets with Dose A, SPH3127 Tablets with Dose B, SPH3127 Tablets placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPH3127 Tablets with Dose ADrug
See Arm description
SPH3127 Tablets with Dose BDrug
See Arm description
SPH3127 Tablets placeboDrug
See Arm description
| Study group | Role | What they receive |
|---|---|---|
| SPH3127 Tablets with Dose A | Experimental | Oral daily dose of SPH3127 Tablets for up to 8 weeks Receives: Drug: SPH3127 Tablets with Dose A |
| SPH3127 Tablets with Dose B | Experimental | Oral daily dose of SPH3127 Tablets for up to 8 weeks Receives: Drug: SPH3127 Tablets with Dose B |
| SPH3127 Tablets placebo | Placebo comparator | Oral daily dose of SPH3127 Tablets placebo for up to 8 weeks Receives: Drug: SPH3127 Tablets placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom remission rate
Symptom remission rate
Measured: Week8
Endoscopic remission rate
Endoscopic remission rate
Measured: Week8
Secondary outcomes (3)
Clinical remission rate
Clinical remission rate
Measured: Week8
Symptom remission rate
Symptom remission rate
Measured: Week2、Week4
Safety and tolerability since the start of any study treatment.
Incidence of adverse event and serious adverse event
, correlation with study drug
Measured: Approximately 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start19 Jun 2023
- Primary completion13 Sep 2024
- Study completion13 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Shanghai Pharmaceuticals Holding Co., LtdThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770609
- Sponsor's protocol ID
- SPH3127-203
- Status last verified
- Apr 2025
- First submitted
- 5 Mar 2023
- Last updated
- 28 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Dose-finding Phase II Clinical Study to Evaluate the Efficacy and Safety of SPH3127 Tablets in the Treatment of Mild to Moderate Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT05770609
- Acronym / sponsor ID
- SPH3127-203
- Conditions
- Mild to Moderate Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 13 Sep 2024 (actual)
- Study completion
- 13 Sep 2024 (actual)
- First posted
- 15 Mar 2023 (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.
To preliminarily evaluate the clinical efficacy of the renin inhibitor SPH3127 Tablets in patients with mild to moderate ulcerative colitis with placebo as a control and determine the recommended dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SPH3127 Tablets with Dose A | Experimental | Drug: SPH3127 Tablets with Dose AOral daily dose of SPH3127 Tablets for up to 8 weeks |
| SPH3127 Tablets with Dose B | Experimental | Drug: SPH3127 Tablets with Dose BOral daily dose of SPH3127 Tablets for up to 8 weeks |
| SPH3127 Tablets placebo | Placebo comparator | Drug: SPH3127 Tablets placeboOral daily dose of SPH3127 Tablets placebo for up to 8 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 - 75 years, male or female;
- Subjects who have been diagnosed with ulcerative colitis；
- Subjects who agree to take effective contraceptive measures with their spouses throughout the study period and for up to 12 weeks after the last dose;
- Subjects who thoroughly learn about the nature, significance, possible benefits, possible inconvenience and potential risks of the trial, understand the study procedures and voluntarily sign the informed consent form prior to their participation in the trial.
Key exclusion criteria (6 listed)
- Subjects who are diagnosed with Crohn's disease or indeterminate colitis;
- Subjects with active infections at screening which may, as evaluated by the investigator, cause increased risks for subjects;
- Subjects who had surgery that might impact the absorption of oral drugs, subjects who will undergo surgery during the study period, subjects who have undergone major surgery before screening, or subjects who have a plan of surgery during the study period;
- Subjects and lactating women and those who will become pregnant within 6 months after the trial starts;
- Subjects with a history of drug abuse with clinical significance within 1 year prior to screening;
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 |
|---|---|---|
| SPH3127 Tablets with Dose ASee Arm description | Drug | SPH3127 Tablets with Dose A |
| SPH3127 Tablets with Dose BSee Arm description | Drug | SPH3127 Tablets with Dose B |
| SPH3127 Tablets placeboSee Arm description | Drug | SPH3127 Tablets placebo |
Primary outcome
Symptom remission rate
Time frame: Week8
Symptom remission rate
Endoscopic remission rate
Time frame: Week8
Endoscopic remission rate
3 secondary outcomes
Clinical remission rate
Time frame: Week8
Symptom remission rate
Time frame: Week2、Week4
Safety and tolerability since the start of any study treatment.
Time frame: Approximately 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SPH3127 Tablets with Dose A and SPH3127 Tablets with Dose B in people with Mild to Moderate Ulcerative Colitis, run by Shanghai Pharmaceuticals Holding Co., Ltd at 25 sites 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom remission rate (time frame: Week8). The study lists 2 primary outcomes in all. 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 28 Aug 2025.