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Tests treatment safety and results for Ulcerative Colitis (UC)
Official title The Purpose of This Study is to Evaluate the Efficacy and Safety of 627 in the Treatment of UC
ClinicalTrials.gov ID: NCT07507513
What this study is testing
What is 627?
627 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for ulcerative colitis (uc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will evaluate the efficacy and safety of 627 in patients with UC.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Able to understand and comply with the requirements of the study protocol, and sign the written informed consent form (ICF).
- Male or female people aged 18-75 years old when signing the ICF.
- people must have been diagnosed with UC for at least 3 months prior to randomization.
- Moderate to Severe Active Ulcerative Colitis (UC).
- Inadequate or lost response, intolerance to one or more therapies, or corticosteroid dependence.
You likely can't join if
- History of severe opportunistic infection within 2 months prior to screening or randomization that remains not adequately controlled.
- Receiving protocol-prohibited treatments prior to screening or randomization.
- Presence of any laboratory test abnormalities during screening and/or determination by the investigator that enrollment in the study may pose...
- Positive hepatitis B test result, positive hepatitis C virus antibody (HCV Ab), positive human immunodeficiency virus antibody (HIV Ab), or positive...
- History of clinically significant cardiovascular and cerebrovascular diseases within 6 months prior to screening.
- History of any malignancy within 5 years prior to screening or currently active malignancy.
See the full eligibility criteria
- Able to understand and comply with the requirements of the study protocol, and sign the written informed consent form (ICF).
- Male or female people aged 18-75 years old when signing the ICF.
- people must have been diagnosed with UC for at least 3 months prior to randomization.
- Moderate to Severe Active Ulcerative Colitis (UC).
- Inadequate or lost response, intolerance to one or more therapies, or corticosteroid dependence.
- Female people of childbearing potential and male people (and their female partners) must use highly effective contraception from the screening period through at least 6 months after the last dose. The people must have...
- History of severe opportunistic infection within 2 months prior to screening or randomization that remains not adequately controlled.
- Receiving protocol-prohibited treatments prior to screening or randomization.
- Presence of any laboratory test abnormalities during screening and/or determination by the investigator that enrollment in the study may pose uncontrollable safety risks to the subject.
- Positive hepatitis B test result, positive hepatitis C virus antibody (HCV Ab), positive human immunodeficiency virus antibody (HIV Ab), or positive serum Treponema pallidum antibody (TP Ab) during screening, as...
- History of clinically significant cardiovascular and cerebrovascular diseases within 6 months prior to screening.
- History of any malignancy within 5 years prior to screening or currently active malignancy.
- Allergy to the investigational medicinal product, any of its components, or excipients.
- History of alcohol or substance abuse within 6 months prior to screening.
- Undergone major surgery within 6 months prior to screening or planned major surgery during the study period.
- Blood donation or significant blood loss within 4 weeks prior to screening.
- Participation in any drug clinical trial within 3 months prior to screening or within 5 half-lives of the investigational drug (whichever is longer).
- Vaccination with live/attenuated live vaccines within 4 weeks prior to screening or planned vaccination during the study period.
- Pregnant or lactating female people.
- Other conditions deemed unsuitable for trial participation by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.