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

Sorriso Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Ulcerative Colitis

Treatments: Drug: SOR102; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06080048

SOR102-101

Details and patient eligibility

About

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).

Enrollment: 22 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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22 participants in 3 patient groups, including a placebo group

Part 3 SOR102 QD

Experimental group

Description:

SOR102 once a day for 6 weeks SOR102 oral capsules

Treatment:

Drug: SOR102

Part 3 SOR102 BID

Experimental group

Description:

SOR102 twice a day for 6 weeks SOR102 oral capsules

Treatment:

Drug: SOR102

Part 3 Placebo

Placebo Comparator group

Description:

Placebo for twice a day for 6 weeks Placebo oral capsules

Treatment:

Drug: Placebo