An Open Label, Phase 2 Study to Evaluate the Effect of A3907 on Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Adults with Primary Sclerosing Cholangitis (PSC)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-500790-14-00

Acronym

A3907-002

Enrollment

Registered

2022-12-15

Start date

2023-01-02

Completion date

2025-07-10

Last updated

2024-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Sclerosing Cholangitis (PSC)

Brief summary

The primary endpoint is safety and tolerability as determined by the incidence of treatment-emergent adverse events (TEAEs) through Week 12

Detailed description

• PK parameters for A3907 including, but not limited to, Cmax, and area under the plasma AUC • Change from Baseline to Week 12 in serum and urine individual and total bile acid levels • Change from baseline to Week 12 in liver transaminases (ALT and AST), GGT, ALP and total and direct bilirubin levels. • Change from Baseline to Week 12 in 7α-hydroxy-4-cholesten-3-one (C4)

Interventions

DRUGA3907

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
The primary endpoint is safety and tolerability as determined by the incidence of treatment-emergent adverse events (TEAEs) through Week 12	—

Secondary

Measure	Time frame
• PK parameters for A3907 including, but not limited to, Cmax, and area under the plasma AUC • Change from Baseline to Week 12 in serum and urine individual and total bile acid levels • Change from baseline to Week 12 in liver transaminases (ALT and AST), GGT, ALP and total and direct bilirubin levels. • Change from Baseline to Week 12 in 7α-hydroxy-4-cholesten-3-one (C4)	—

Countries

France, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026