NCT06080048

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2023

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

October 24, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2024

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2024

Completed
Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

12 months

First QC Date

October 6, 2023

Last Update Submit

November 26, 2024

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • Treatment Emergent Adverse Events following oral dosing

    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

    Up to 6 weeks in Part 3 or at the time of study discontinuation

Secondary Outcomes (3)

  • SOR102 concentrations following oral dosing

    Up to 6 weeks in Part 3 or at the time of study discontinuation

  • Incidence of positive ADAs to SOR102

    Following 6 weeks of study treatment in Part 3 or at the time of study discontinuation

  • Incidence of positive neutralizing ADA

    Following 6 weeks of study treatment in Part 3 or at the time of study discontinuation

Study Arms (3)

Part 3 SOR102 QD

EXPERIMENTAL

SOR102 once a day for 6 weeks SOR102 oral capsules

Drug: SOR102

Part 3 SOR102 BID

EXPERIMENTAL

SOR102 twice a day for 6 weeks SOR102 oral capsules

Drug: SOR102

Part 3 Placebo

PLACEBO COMPARATOR

Placebo for twice a day for 6 weeks Placebo oral capsules

Drug: Placebo

Interventions

SOR102DRUG

SOR102 capsules

Part 3 SOR102 BIDPart 3 SOR102 QD
PlaceboDRUG

Matching placebo capsules

Part 3 Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Arensia Exploratory Medicine

Tbilisi, Georgia

Location

Arensia Exploratory Medicine

Kyiv, Ukraine

Location

Related Publications (1)

  • Jairath V, Danese S, D'Haens GR, Feagan BG, Peyrin-Biroulet L, Sands BE, Gaemers I, Westfall M, Terry AQ, Roberts KJ, Barbat S, Wedel P, Benson JM, Sattler C. Safety and pharmacokinetics of SOR102, an oral bispecific inhibitor of TNF and interleukin-23 in healthy participants and patients with ulcerative colitis: a first-in-human, double-blind, randomised, placebo-controlled, phase 1 trial. Lancet Gastroenterol Hepatol. 2026 Jan;11(1):34-45. doi: 10.1016/S2468-1253(25)00296-1. Epub 2025 Nov 13.

    PMID: 41242336DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Carlos C Sattler, MD

    Sorriso Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2023

First Posted

October 12, 2023

Study Start

October 24, 2023

Primary Completion

October 16, 2024

Study Completion

November 8, 2024

Last Updated

November 29, 2024

Record last verified: 2024-11

Locations

GE(1)UA(1)