PATH-2: PTH Attenuation Trial in Hemodialysis-2

• Sponsor: Pathalys Pharma (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05836220
• Collaborator: Launch Therapeutics (Other)
• Enrollment: 375
• Arms: 3
• Anticipated Duration (Months): 24

Study Details

Study Description

Brief Summary

This study is to evaluate the efficacy and safety of PLS240 in patients with hemodialysis-dependent end stage kidney disease (ESKD) and secondary hyperparathyroidism (SHPT). The study consists of two phases. First, a placebo-controlled, double-blind phase where patients will be randomly assigned to either receive dose-titrated PLS240 or matching placebo for 27 weeks. After the completion of the double-blind phase, patients will be eligible to enroll in the open-label extension phase, where they will receive dose-titrated PLS240 for an additional 26 weeks. Throughout the duration of the study, patients will be expected to attend multiple study visits where an investigator will collect blood, preform electrocardiograms (ECGs) and physical exams, and further assess the safety and efficacy of PLS240.

Condition or Disease	Intervention/Treatment	Phase
Secondary Hyperparathyroidism; End Stage Kidney Disease	Drug: PLS240; Drug: Placebo; Drug: Open-Label Extension PLS240	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 375 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Dose-Titrated PLS240 in the Treatment of Secondary Hyperparathyroidism in Individuals With End Stage Kidney Disease on Hemodialysis (PATH-2) With an Open-Label Extension
• Anticipated Study Start Date: May 1, 2023
• Anticipated Primary Completion Date: May 1, 2025
• Anticipated Study Completion Date: May 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Double-Blind Phase PLS240	Drug: PLS240; Participants will receive intravenous (IV) PLS240 three times per week for 27 weeks.
Placebo Comparator: Double-Blind Phase Placebo	Drug: Placebo; Participants will receive intravenous (IV) placebo, containing no active drug, three times per week for 27 weeks.
Experimental: Open-Label Extension Phase PLS240 After completion of the Double-Blind Phase, all participants will have the opportunity to enroll in the 26 week Open-Label extension, where they will receive PLS240.	Drug: Open-Label Extension PLS240; Participants will receive intravenous (IV) PLS240 three times per week for a maximum of 26 weeks.

Outcome Measures

Primary Outcome Measures

1. The proportion of PLS240 treated participants compared to the portion of placebo treated participants with a ≥30% decrease in mean iPTH during the Efficacy Assessment Period (Weeks 22 - 27) relative to the mean baseline iPTH (week 1 and predose Day1) [each visit from screening through week 27]

   Double-Blind Phase only

2. Open-Label Phase: Proportion of participants with a corrected serum calcium (cCa) <7.5 mg/dL [up to week 28]

3. Open-Label Phase: Proportion of participants with a corrected serum calcium (cCa) <8.3 mg/dL [up to week 28]

4. Open-Label Phase: Number of AE's [up to week 28]

5. Open-Label Phase: Number of SAE's [up to week 28]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Prescribed hemodialysis for 3 times per week and on therapy for at least 3 months

• Women who are not of child-bearing potential must commit to remain abstinent or are willing to use highly effective contraception during the study and for 2 weeks after the last dose of investigational product

• Women of child-bearing potential must have a negative serum pregnancy test

• Male participants must be willing to use highly effective contraception and not donate sperm during the treatment phase and for 2 weeks after the last dose of investigational product

• For Open-Label Extension only: Participants must have completed the final safety follow-up of the Double-Blind Phase

Exclusion Criteria:

• Diagnosis of primary hyperparathyroidism

• History of parathyroid intervention including parathyroidectomy (PTx) and percutaneous ethanol injection therapy (PEIT) within 26 weeks before screening

• Anticipated or scheduled parathyroidectomy during the study period

• Planned kidney transplant during the study period

• Noncompliant with hemodialysis (i.e., missing more than 2 sessions within 8 weeks prior to screening)

• Having been hospitalized, other than for dialysis, within 30 days before screening

• History of malignancy within the last 2 years prior to screening (except squamous or basal cell skin cancers, or cervical carcinoma in situ)

• History of myocardial infarction (heart attack), coronary angioplasty, or coronary arterial bypass grafting within the past 4 months prior to screening

• Stroke within 6 months before screening

• Pregnant or breast feeding

• Current, recent, or suspected infection within 4 weeks of screening of SARS-CoV-2/COVID-19

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pathalys Pharma
• Launch Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pathalys Pharma
• ClinicalTrials.gov Identifier: NCT05836220
• Other Study ID Numbers: PP3003; 2023-504339-41
• First Posted: May 1, 2023
• Last Update Posted: May 1, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasm Metastasis; Kidney Diseases; Kidney Failure, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary

Study Results

No Results Posted as of May 1, 2023