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The Purpose of This Study is to Evaluate the Efficacy and Safety of 627 in the Treatment of UC

ConditionUlcerative Colitis (UC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

About this trial

This study will evaluate the efficacy and safety of 627 in patients with UC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able to understand and comply with the requirements of the study protocol, and sign the written informed consent form (ICF).

Male or female subjects aged 18-75 years old when signing the ICF.

Subjects must have been diagnosed with UC for at least 3 months prior to randomization.

Moderate to Severe Active Ulcerative Colitis (UC).

Disqualifiers

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 specified in the protocol.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 627

    Drug

    627 subcutaneous (SC) injection.

  • Placebo

    Drug

    Placebo subcutaneous (SC) injection.

Treatment groups

288 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Group M1Experimental treatment 2 interventions
Group B: Group M2Experimental treatment 2 interventions
Group C: Group M3Experimental treatment 2 interventions
Group D: Group M4Experimental treatment 2 interventions
Group E: Group AExperimental treatment 1 intervention
Group F: Group BExperimental treatment 1 intervention
Group G: PlaceboPlacebo comparator 1 intervention
Group H: Group CExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with Adverse Events

Time frame
During the 36-week study period

Secondary outcomes

1

Clinical remission based on Mayo Score (MMS)

Proportion of subjects achieving clinical remission based on Mayo Score (MMS) (Rectal Bleeding Score \[RBS\] = 0, Endoscopic Score \[ES\] ≤ 1 without friability, and Stool Frequency Score \[SFS\] ≤ 1and not exceeding baseline).

Time frame
Week 14
2

Clinical response based on Mayo Score (MMS)

Proportion of subjects achieving clinical response based on Mayo Score (MMS) (≥2-point and ≥30% reduction in MMS from baseline, and ≥1-point reduction in Rectal Bleeding Score \[RBS\] or RBS value ≤1 point).

Time frame
Week 14
3

Endoscopic improvement

Proportion of subjects achieving endoscopic improvement (Endoscopic Score \[ES\] ≤ 1 without friability).

Time frame
Week 14
4

Endoscopic remission

Proportion of subjects achieving endoscopic remission (Endoscopic Score \[ES\] = 0).

Time frame
Week 14

Other outcomes

1

Peak Plasma Concentration (Cmax).

Time frame
During the 36-week study period
2

Area under the Concentration-Time Curve up to the Last Measurable Concentration (AUC 0-last).

Time frame
During the 36-week study period.
3

Time to Peak Concentration (Tmax).

Time frame
During the 36-week study period.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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