A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G

Part of paid clinical trials in Lawrenceville, Georgia.

Sponsor
Akebia Therapeutics
Study ID
NCT06419205
Phase
PHASE2
Status
Recruiting
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Conditions

  • C3 (Complement Component 3) Glomerulopathy
  • IgA Nephropathy
  • Lupus Nephritis (LN)

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ADX-097 — DRUG
    Subcutaneous Infusions

Study Details

A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 16 Years or Older with Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), or Complement Component 3 Glomerulopathy (C3G)

Key Dates

First listed
May 17, 2024
Start date
Jul 30, 2026
Status verified
Aug 2026
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Open Label: ADX-097
    Participants will be administered ADX-097 weekly once

Primary Outcome Measure

Number of participants reporting treatment emergent adverse events (TEAEs) [ Time Frame: Up to 30 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Investigator Site #1LawrencevilleGeorgia30046-

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Investigator· Lawrenceville, GA

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