A Clinical Trial to Assess the Safety of SOR102 in Healthy Participants and Patients With Ulcerative Colitis

Phase 1

Completed

• Conditions: Ulcerative Colitis
• Interventions: Drug: SOR102; Drug: Placebo

• Registration Number: NCT06080048
• Lead Sponsor: Sorriso Pharmaceuticals, Inc.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-06
• Study First Submitted QC: 2023-10-06
• Study First Posted: 2023-10-12
• Study Start: 2023-10-24
• Primary Completion: 2024-10-16
• Status Verified: 2024-11
• Study Completion: 2024-11-08
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part 3 SOR102 QD	SOR102	SOR102 once a day for 6 weeks SOR102 oral capsules
Part 3 SOR102 BID	SOR102	SOR102 twice a day for 6 weeks SOR102 oral capsules
Part 3 Placebo	Placebo	Placebo for twice a day for 6 weeks Placebo oral capsules

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Arensia Exploratory Medicine; 🇺🇦 Kyiv, Ukraine