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)

The purpose of this study is to assess the safety and efficacy of ABBV-CLS-628 for the treatment of ADPKD in adult participants. To evaluate the safety, tolerability, and potential efficacy of ABBV-CLS-628 in slowing disease progression in ADPKD.

CT.gov Identifier
NCT06902558
EudraCT Identifier
N/A
CTIS:
2024-517143-31-00
Sponsor
AbbVie
Collaborator
Calico Life Sciences
Study Contact Information
+1 800 255 5162
Recruiting
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Study Details

Diseases
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Study Drug
ABBV-CLS-628
Genes
PKD1
GANAB
Study Dates
Jun 2025 - Aug 2029
Sex
Female & Male
Age
18 - 55 Years
Inclusion and Exclusion Criteria
Inclusion Criteria:
  • * Autosomal Dominant Polycystic Kidney Disease (ADPKD) Class 1C, 1D, or 1E based on the Mayo Clinic Imaging Classification of ADPKD.
  • * Estimated glomerular filtration rate (eGFR) \>= 30 mL/min/1.73 m\^2 and \< 90 mL/min/1.73 m\^2, using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at Screening.
Exclusion Criteria:
  • * Current interventions to treat ADPKD such as non-approved medications or lifestyle modifications.
  • * Any exclusionary medical diseases, disorders, or conditions as described in the protocol.

Protocol Summary

The purpose of this study is to assess the safety and efficacy of ABBV-CLS-628 for the treatment of ADPKD in adult participants.

To evaluate the safety, tolerability, and potential efficacy of ABBV-CLS-628 in slowing disease progression in ADPKD.

Study Locations

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