Health TrialsbyHealthPanel

Evaluation of Efficacy, Safety, and Tolerability of Povetacicept in Participants With Primary Membranous Nephropathy (pMN)

ConditionPrimary Membranous Nephropathy
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorVertex Pharmaceuticals Incorporated

About this trial

The purpose of this study is to evaluate the efficacy, safety, and tolerability of povetacicept in participants with primary membranous nephropathy (pMN).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

  • Povetacicept

    Drug

    Solution for Subcutaneous Injection.

  • Tacrolimus

    Drug

    Capsules for Oral Administration.

Treatment groups

176 Participants
are divided into 3 treatment groups
Group A: Phase 2b: PovetaciceptExperimental treatment 1 intervention
Group B: Phase 3: PovetaciceptExperimental treatment 1 intervention
Group C: Phase 3: Calcineurin Inhibitor (CNI)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of Participants with Complete Clinical Remission Definition 1 (CR1)

Time frame
At Week 104

Secondary outcomes

1

Proportion of Participants with Complete Clinical Remission Definition 2 (CR2)

Time frame
At Week 104
2

Proportion of Participants with Overall Clinical Remission (OR)

Time frame
At Week 104
3

Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs)

Time frame
From Day 1 up to Week 112

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vertex Pharmaceuticals Incorporated

Lead sponsor

Zai Lab (Shanghai) Co., Ltd. (for China only)

Collaborator

Source ClinicalTrials.gov
Apply now