An Investigation of Oral BT051 in Subjects With Moderately to Severely Active Ulcerative Colitis (UC)

Completed · Phase 1 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

This is a randomised, double-blind, placebo-controlled study to assess the safety and tolerability of multiple ascending doses of BT051 in subjects with moderately to severely active ulcerative colitis. Subjects will be randomised using a 3 active:1 placebo ratio to 3 ascending dose cohorts of 8 subjects and will be dosed daily for 28 days. The 3 initial dose levels will be 200 mg, 800 mg and 3200 mg per day. Progression to the next cohort will be based on the safety and tolerability of the previous cohort.

Key facts

Study ID

NCT05084261

Run by

Adiso Therapeutics

People needed

24

Starts

2021-11-30

Expected to finish

2022-11-30

Last updated by the study team

2024-02-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provide written documentation of informed consent to participate in the study.
• Male or female aged 18 to 75 years.
• Subjects with a confirmed diagnosis of UC of at least 3 months' disease duration prior to Screening (diagnosis established by endoscopy and histology).
• Moderately to severely active UC, defined as a Mayo Score ≥6 points with a rectal bleeding subscore ≥1 point, a stool frequency subscore ≥1 point, and moderate to severe disease on endoscopy (Mayo endoscopic subscore [MES] ≥2 points).
• Subjects treated with stable doses (>4 weeks) of the following UC treatments prior to randomization: 6-mercaptopurine, azathioprine, sulfasalazine or 5-aminosalicylic acid. Subjects will need to maintain stable doses of these drugs for at least 4 weeks during study treatment and an additional 7 days of follow-up.
• Subjects treated with oral corticosteroids will be eligible if the dose is ≤20 mg/day prednisone (≤9 mg/day budesonide) or equivalent. The corticosteroid therapy will have to be stable for at least 2 weeks prior to the Screening sigmoidoscopy, throughout study treatment and an additional 7 days of follow-up.
• Colonoscopy within the past 1 year to exclude adenomas, dysplasia, and colon cancer for subjects with 1/3 of colon involved and 8 years of disease; those without a colonoscopy in the past year may use the Screening colonoscopy to confirm eligibility.
• Female subjects must be surgically sterile, postmenopausal (i.e., no menses for at least 2 years or documented by follicle stimulating hormone), or if of child-bearing potential must have a negative pregnancy test and must be willing to use a highly effective form of contraceptive through 30 days after the last dose of study drug. The following are considered highly effective contraceptives: combined and progestogen-only hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal, injectable, implantable), intrauterine device/hormone-releasing system, bilateral tubal occlusion, vasectomized partner, or abstinence. Abstinence should only be used as a contraceptive method if it is in line with the subject's usual and preferred lifestyle. Periodic abstinence (calendar, symptothermal, post ovulation methods) is not an acceptable method of contraception.
• Male subjects must be surgically sterile, abstinent, agree to use an appropriate contraception method (i.e., condom), or have a female sexual partner who is surgically sterile, postmenopausal, or using a highly effective form of contraceptive as noted above through 30 days after the last dose of study drug. Abstinence should only be used as a contraceptive method if it is in line with the subject's usual and preferred lifestyle.
• General Exclusion Criteria
• Any clinically significant disease: renal, hepatic, neurological, cardiovascular, pulmonary, endocrinology, psychiatric, hematologic, urologic, or other acute or chronic disease that in the opinion of the Investigator would not make the subject a suitable candidate for this study.
• Subjects with planned hospitalization or surgery during the course of the study.
• Female subjects who have a positive pregnancy test, are breast feeding, or intend to become pregnant during the course of the study. Male subjects who intend female partner pregnancy during the course of the study.
• Known hypersensitivity to any of the components of BT051 drug product including cyclosporine A and polyethylene glycol.
• Relative to upper limit of normal (ULN):
• Serum bilirubin >1.5×
• Serum creatinine >1.5×
• Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) >2.0×
• International normalized ratio (INR) >1.5
• Hemoglobin <8 g/dL
• Cell counts (/μL):
• Platelets <100,000 or >800,000
• White blood cells <3500
• Absolute neutrophil count <1500
• Systemic antibiotic, antiviral, or anti-fungal therapy within the 2 weeks prior to Screening.

Where it is running

• Inland Empire Clinical Trials, LLC — Rialto, California, United States
• I.H.S. Health, LLC — Kissimmee, Florida, United States
• Research Institute of Clinical Medicine Todua Clinic — Tbilisi, Georgia
• Republican Clinical Hospital - Timofei Mosneaga — Chisinau, Moldova
• WIP Warsaw IBD Point — Warsaw, Poland
• PlanetMed Gastroenterology — Wroclaw, Poland

Full record on ClinicalTrials.gov

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