Ulcerative Colitis
Conditions
Brief summary
SOR102-101 is a Phase 1, 3-part, randomised, double-blind, placebo-controlled, FIH study to determine the safety, tolerability, and PK of single, ascending oral doses (SAD) of SOR102 (Part 1) and multiple oral doses (Part 2) of SOR102 in healthy adult participants, and to assess the safety, tolerability, PK, and biological activity of multiple oral doses of SOR102 in patients with mild to severe UC (Part 3).
Interventions
DRUGSOR102
SOR102 capsules
DRUGPlacebo
Matching placebo capsules
Sponsors
Sorriso Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Male or females, of any ethnic origin. * Established diagnosis of UC by standard criteria for \>3 months. * Disease evaluable by sigmoidoscopy. * Mildly to severely active UC as determined by central reader in combination with other assessments of disease Key
Exclusion criteria
* Any diagnosis of IBD except for UC. * History of fistula(e), strictures or surgery, known intestinal obstruction, or diagnosis of toxic megacolon. * Concurrent use of any biologic drug. * Prior primary efficacy failure or secondary loss of response to more than one biologic or new small molecule therapy (i.e., JAK inhibitors or S1P receptor modulators) indicated for the treatment of UC. This does not include prior discontinuation due to drug intolerance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Emergent Adverse Events following oral dosing | Up to 6 weeks in Part 3 or at the time of study discontinuation | After multiple oral doses administered BID or QD, number of subjects with AEs in the SOR102 dose level cohorts compared with the oral placebo group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SOR102 concentrations following oral dosing | Up to 6 weeks in Part 3 or at the time of study discontinuation | To determine the concentration of SOR102 in serum, urine and feces. |
| Incidence of positive ADAs to SOR102 | Following 6 weeks of study treatment in Part 3 or at the time of study discontinuation | To assess the incidence of positive ADAs to SOR102. |
| Incidence of positive neutralizing ADA | Following 6 weeks of study treatment in Part 3 or at the time of study discontinuation | To assess the incidence of positive neutralizing ADA to SOR102 and its monomers in patients with positive ADA to SOR102. |
Countries
Georgia, Ukraine
Outcome results
None listed