NCT05019742

Evaluation of SPH3127 in Patients With Mild-to-Moderate Ulcerative Colitis

Terminated Phase 2 Results posted Last updated 26 June 2025

What this trial tests

Phase 2 trial testing SPH3127 in Ulcerative Colitis in 3 participants. Terminated before completion.

Timeline

21 March 2022

Primary endpoint
1 November 2022

1 November 2022

Quick facts

Lead sponsor	Shanghai Pharma Biotherapeutics USA Inc.
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	3
Start date	21 March 2022
Primary completion	1 November 2022
Estimated completion	1 November 2022
Sites	16 locations across United States

Drugs / interventions tested

• SPH3127
• Placebo

Conditions studied

• Ulcerative Colitis — all drugs for Ulcerative Colitis →

Sponsor

Shanghai Pharma Biotherapeutics USA Inc.

Who can join

Adults 18 to 70, any sex, with Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Patients With Clinical Remission Primary · Screening (baseline) to Day 56

Number of patients with Clinical remission from baseline to Day 56

Group	Value	95% CI
Placebo	0
SPH3127 50 mg	0
SPH3127 100 mg	1

Number of Patients With Endoscopic Remission Primary · Screening (baseline) to Day 56

Number of patients with Endoscopic remission from baseline to Day 56

Group	Value	95% CI
Placebo	0
SPH3127 50 mg	0
SPH3127 100 mg	1

Number of Patients Reporting Adverse Events Secondary · Baseline to Day 56 or date of study termination for the 3 patients (i.e., < 80 days per patient)

Number of patients reporting an adverse event (regardless of its relationship to study drug) will be tabulated and classified using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA) classification system.

Group	Value	95% CI
Placebo	2
SPH3127 50 mg	0
SPH3127 100 mg	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline to Day 56 or date of study termination for the 3 patients (i.e., < 80 days per patient).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 0/2 (0%)

Deaths: 0/2

SPH3127 50 mg

Serious: 0

Deaths: 0

SPH3127 100 mg

Serious: 0/1 (0%)

Deaths: 0/1

Other adverse events (2 terms — click to expand)

Reaction	System	Placebo	SPH3127 50 mg	SPH3127 100 mg
cough	Respiratory, thoracic and mediastinal disorders	—	—	—
ulcerative colitis flare	Gastrointestinal disorders	—	—	—

Data from ClinicalTrials.gov NCT05019742 adverse events section.

Sponsor's own description

SPH3127-US-01 is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics, and preliminary efficacy of SPH3127 for the treatment of mild-to-moderate ulcerative colitis.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Paradigm Shift in Inflammatory Bowel Disease Management: Precision Medicine, Artificial Intelligence, and Emerging Therapies.
   Caballero Mateos AM, Cañadas de la Fuente GA, Gros B. · · 2025 · cited 7× · PMID 40095460 · DOI 10.3390/jcm14051536