Phase 2 Crohn's Disease and Colitis Trial, Recruiting NCT07507513 Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. Condition: Crohn's Disease and Colitis
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Phase 2 Crohn's Disease and Colitis Trial, Recruiting

NCT07507513
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are able to understand the study requirements and agree in writing to take part.
  • People aged 18 to 75 years old at the time of signing the agreement to participate.
  • People who have been diagnosed with ulcerative colitis (a condition causing inflammation of the large intestine) for at least 3 months before entering the trial.
  • People with moderate to severe active ulcerative colitis.
  • People whose condition has not responded well to, or who have lost response to, or who cannot tolerate one or more existing treatments, or who are dependent on corticosteroid medications.
  • People who are able to use highly effective contraception from the screening period until at least 6 months after the last dose of the study treatment, and who have no plans for pregnancy, sperm donation, or egg donation during that time (applies to women who could become pregnant and to men and their female partners).

Who may not be able to join:

  • People who have had a serious opportunistic infection (a type of infection that takes advantage of a weakened immune system) within the past 2 months that has not been adequately treated.
  • People who are currently receiving treatments that are not permitted under the trial rules.
  • People whose blood test results during screening show abnormalities, or where the doctor running the trial considers participation may pose uncontrollable safety risks.
  • People who test positive for hepatitis B, hepatitis C, HIV, or syphilis during screening.
  • People who have had a significant heart or stroke-related condition within the 6 months before screening.
  • People who have had any cancer in the past 5 years, or who currently have an active cancer.
  • People who have a known allergy to the study drug or any of its ingredients.
  • People who have had problems with alcohol or substance misuse within the 6 months before screening.
  • People who have had major surgery within the 6 months before screening, or who have major surgery planned during the trial.
  • People who have donated blood or experienced significant blood loss within 4 weeks before screening.
  • People who have taken part in another drug clinical trial within the past 3 months, or within a specific timeframe related to that drug's clearance from the body — whichever is longer.
  • People who have received a live or live-attenuated vaccine (such as certain flu or travel vaccines) within 4 weeks before screening, or who plan to receive one during the trial.
  • People who are currently pregnant or breastfeeding.
  • People whom the trial doctor considers unsuitable for participation for any other reason.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: +86 18911301578

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Registry
ClinicalTrials.gov
Start date
28 March 2026
Est. completion
28 February 2029

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Number of participants with Adverse Events

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov