A Study of ABBV-CLS-628 in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Calico Life Sciences LLC

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

18 Jul 2025 → ongoing

Decision date (initial)

2025-07-07

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

AbbVie Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To assess the safety and efficacy of ABBV-CLS-628 in trial participants with Autosomal Dominant Polycystic Kidney Disease (ADPKD).

Conditions and MedDRA coding

Autosomal Dominant Polycystic Kidney Disease

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Trial participants must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any washout, screening or study-specific procedures.
2. Age 18 (or higher age limit defined per regional definitions) to 55 years of age, both inclusive at the time of consent.
3. Diagnosis of Autosomal Dominant Polycystic Kidney Disease (ADPKD).
4. ADPKD Classe 1C, 1D, or 1E based on the Mayo Clinic Imaging Classification of ADPKD.
5. eGFR >= 30 mL/min/1.73 m2 and < 90 mL/min/1.73 m2 , using the CKD-EPI equation at Screening.
6. Negative serum pregnancy test at Screening and negative urine pregnancy test at baseline.
7. Female trial participants of childbearing potential enrolled must agree to use two forms of protocol-specified, contraception, one of which is highly effective from Study Day 1.

Exclusion criteria 10

1. Current interventions to treat ADPKD such as non-approved medications or lifestyle modifications.
2. Concurrent participation in any other interventional trial.
3. Any exclusionary medical diseases, disorders, or conditions.
4. Hypertension not controlled by antihypertensive therapy (per investigator's judgment) at screening and baseline.
5. History of Renal Replacement Therapy.
6. Anticipated need for dialysis or transplantation within the next year.
7. Any active infections including but not limited to the following: Positive for HIV, HBV, HCV.
8. Immunocompromised per investigator's judgment.
9. History of clinically significant (per investigator's discretion) drug or alcohol abuse within the last 6 months prior to Screening.
10. Positive result on the urine drug screen at Screening unless explained by concomitant medication use.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Cumulative rate of change from baseline in TKV by MRI at Week 96.

Secondary endpoints 2

1. Absolute change in eGFR from baseline at Week 96.
2. Cumulative rate of change from baseline in TKV by MRI at Week 48.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Calico Life Sciences LLC

Sponsor organisation

Calico Life Sciences LLC

Address

1170 Veterans Boulevard

City

South San Francisco

Postcode

94080-1985

Country

United States

Scientific contact point

Organisation

Calico Life Sciences LLC

Contact name

Anna Rodriguez

Public contact point

Organisation

Calico Life Sciences LLC

Contact name

Anna Rodriguez

Third parties 11

Locations

7 EU/EEA countries · 34 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 62 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications