Clinical trial NCT06902558: A Study to Assess Adverse Events and Effectiveness of IntraVenous Infusions of ABBV-CLS-628 in Adult Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Autosomal Dominant Polycystic Kidney Disease
Keywords: Autosomal Dominant Polycystic Kidney Disease (ADPKD)
ABBV-CLS-628
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Calico Life Sciences LLC
First posted: 2025-03-30
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Autosomal Dominant Polycystic Kidney Disease (ADPKD) is the most common genetic cause of kidney disease that causes fluid-filled cysts to develop in the kidneys. The purpose of this study is to assess the safety and efficacy of ABBV-CLS-628 for the treatment of ADPKD in adult participants.

ABBV-CLS-628 is an investigational drug being developed for the treatment of ADPKD. Participants are placed in 1 of 4 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to placebo. Around 240 adult participants with ADPKD will be enrolled at approximately 100 sites worldwide.

Participants will receive IntraVenous ABBV-CLS-628 or placebo every 4 weeks for 92 weeks. Participants will be followed for up to 15 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care . Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility 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.

Primary outcomes:
measure: Cumulative Rate of Change from Baseline in Total Kidney Volume (TKV)
timeFrame: Week 96
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to approximately 118 weeks
Secondary outcomes:
measure: Absolute Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline
timeFrame: Week 96
measure: Cumulative Rate of Change from Baseline in Total Kidney Volume (TKV)
timeFrame: Week 48
measure: Absolute Change in eGFR From Baseline
timeFrame: Week 48
measure: Time From Randomization to the First Occurrence of Clinical Progression to End-Stage Kidney Disease (ESKD) or >= 40% Decline in eGFR
timeFrame: Up to Week 96
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: