Evaluation of SPH3127 in Patients With Mild-to-Moderate Ulcerative Colitis (NCT05019742) | Clinical Trial Compass
TerminatedPhase 2
Evaluation of SPH3127 in Patients With Mild-to-Moderate Ulcerative Colitis
Stopped: Shanghai Pharma Biotherapeutics USA Inc. experienced difficulty in recruiting clinical research sites and in enrolling patients with ulcerative colitis, and consequently, the study was terminated due to futility.
United States3 participantsStarted 2022-03-21
Plain-language summary
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.
Who can participate
Age range18 Years ā 70 Years
SexALL
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Inclusion criteria
ā. Signed Informed Consent Form (ICF);
ā. Adult males and females ā„ 18 to \< 70 years of age on the day of signing the ICF.
ā. A diagnosis of UC (documented or confirmed at screening) will be eligible provided they have mild-to-moderate active UC extending ā„ 15 cm from the anal verge.
ā. At screening/baseline, a Modified Mayo Clinic Score (MMCS) from 4-9, a rectal bleeding subscore ā„ 1, and a Mayo Clinic Endoscopic Subscale (MCES) score ā„ 2 determined by central reading.
ā. Patient has a negative urine drug screen (e.g., amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone) at Screening.
ā. Patient has a negative alcohol breath test at Screening.
ā. Female patients who have a negative pregnancy test at Screening and who agree to use adequate birth control methods throughout the entire study (and extension, if applicable) or who is post-menopausal (i.e., amenorrhea ā„ 1 year) or who have been surgically sterilized.
ā. Male patients with partners of child-bearing potential who agree to use adequate birth control methods throughout the entire study (and extension, if applicable) or who have been surgically sterilized.
Exclusion criteria
ā. Diagnosis of severe UC, defined as the presence of ā„ 6 bloody stools daily with one or more of the following: (1) oral temperature \> 37.8Ā°C or \> 100.0Ā°F; (2) pulse \> 90 beats/min; (3) hemoglobin concentration \< 10.5 g/dL; or erythrocyte sedimentation ratio (ESR) \> 30.
. Patients treated with oral mesalamine \>2.4 g/d, systemic steroids or rectal steroids within 4 weeks prior to randomization, rectal mesalamine (within 2 weeks), immunomodulators or immunosuppressant drugs, including, but not limited to, IL-6 inhibitors, TNF inhibitors, anti-IL-1 agents and JAK inhibitors within 5 half-lives prior to randomization, antibiotics, anti-diarrheals (within 2 weeks), drugs blocking the renin-angiotensin system (e.g., direct renin inhibitors, angiotensin converting enzyme inhibitors, or angiotensin II receptor blockers) (within 4 weeks) or administration of any investigational drug (within 4 weeks). Because SPH3127 is a direct renin inhibitor with the potential to reduce blood pressure, other classes of antihypertensives (e.g., calcium channel blockers, beta blockers, diuretics, direct vasodilators, alpha blockers, central Ī±2 antagonists) (within 4 weeks) will also be excluded. Drugs, herbal medicines and substances that inhibit or induce CYP3A4 (e.g., ritonavir, itraconazole, grapefruit juice) (within 2 weeks or 5 half-lives, whichever is longer) will be excluded.
ā. History of colectomy or partial colectomy, colorectal dysplasia, Crohn's disease, toxic megacolon, or bleeding disorders.
ā. A stool sample positive for enteric pathogens, including Clostridium difficile.
ā. Patients with an estimated glomerular filtration rate (eGFR) \< 60.
ā. Patients with hepatic impairment or history of liver cirrhosis.
ā. Serum creatinine \> 1.5 times the upper limit of normal, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (TBIL) or alkaline phosphatase (ALP) \> 2 times the upper limit of normal.