A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of ABBV-CLS-628 in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517143-31-00

Acronym

M25-147

Enrollment

Registered

2025-07-07

Start date

2025-07-18

Completion date

Unknown

Last updated

2025-09-12

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

Conditions

Autosomal Dominant Polycystic Kidney Disease

Brief summary

Cumulative rate of change from baseline in TKV by MRI at Week 96.

Detailed description

Absolute change in eGFR from baseline at Week 96., Cumulative rate of change from baseline in TKV by MRI at Week 48.

Interventions

DRUGPlacebo for ABBV-CLS-628

DRUGABBV-CLS-628

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Cumulative rate of change from baseline in TKV by MRI at Week 96.	—

Secondary

Measure	Time frame
Absolute change in eGFR from baseline at Week 96., Cumulative rate of change from baseline in TKV by MRI at Week 48.	—

Countries

Belgium, France, Germany, Italy, Netherlands, Portugal, Spain

Outcome results

None listed

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