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)

AbbVie

Status and phase: Not yet enrolling; Phase 2

Conditions: Autosomal Dominant Polycystic Kidney Disease

Treatments: Drug: ABBV-CLS-628; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06902558

M25-147

2024-517143-31-00 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 4 patient groups, including a placebo group

ABBV-CLS-628 Dose A

Experimental group

Description:

Participants will receive ABBV-CLS-628 Dose A every 4 weeks for 92 weeks.

Treatment:

Drug: ABBV-CLS-628

ABBV-CLS-628 Dose B

Experimental group

Description:

Participants will receive ABBV-CLS-628 Dose B every 4 weeks for 92 weeks.

Treatment:

Drug: ABBV-CLS-628

ABBV-CLS-628 Dose C

Experimental group

Description:

Participants will receive ABBV-CLS-628 Dose C every 4 weeks for 92 weeks.

Treatment:

Drug: ABBV-CLS-628

Placebo

Placebo Comparator group

Description:

Participants will receive ABBV-CLS-628 Placebo every 4 weeks for 92 weeks.

Treatment:

Drug: Placebo