ABBV-CLS-628 for Polycystic Kidney Disease

Recruiting at 8 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: AbbVie

Must not be taking: Non-approved medications

Disqualifiers: Exclusionary medical diseases, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 92 weeks

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

Adults with Autosomal Dominant Polycystic Kidney Disease (ADPKD) who have a certain level of kidney function can join this study. They must fall into specific ADPKD classes based on Mayo Clinic's classification.

Inclusion Criteria

My kidney disease is classified as 1C, 1D, or 1E by the Mayo Clinic.

My kidney function is moderately reduced but not severely.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive IntraVenous ABBV-CLS-628 or placebo every 4 weeks

92 weeks

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-CLS-628

Trial Overview The trial is testing ABBV-CLS-628, a new drug for ADPKD. Participants are randomly assigned to one of four groups, receiving either the drug or placebo intravenously every 4 weeks for about 2 years, followed by a short observation period.

How Is the Trial Designed?

Group I: ABBV-CLS-628 Dose C Experimental Treatment 1 Intervention

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

Group II: ABBV-CLS-628 Dose B Experimental Treatment 1 Intervention

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

Group III: ABBV-CLS-628 Dose A Experimental Treatment 1 Intervention

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

Group IV: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Calico Life Sciences LLC

Industry Sponsor

Trials

11

Recruited

960+