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)
Purpose
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.
Condition
- Autosomal Dominant Polycystic Kidney Disease
Eligibility
- Eligible Ages
- Between 18 Years and 55 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental ABBV-CLS-628 Dose A |
Participants will receive ABBV-CLS-628 Dose A every 4 weeks for 92 weeks. |
|
|
Experimental ABBV-CLS-628 Dose B |
Participants will receive ABBV-CLS-628 Dose B every 4 weeks for 92 weeks. |
|
|
Experimental ABBV-CLS-628 Dose C |
Participants will receive ABBV-CLS-628 Dose C every 4 weeks for 92 weeks. |
|
|
Placebo Comparator Placebo |
Participants will receive ABBV-CLS-628 Placebo every 4 weeks for 92 weeks. |
|
Recruiting Locations
Kansas City 4273837, Kansas 4273857 66160
More Details
- Status
- Recruiting
- Sponsor
- AbbVie