Study to Evaluate Avacopan in Combination With a Rituximab or Cyclophosphamide-containing Regimen, in Children From 6 Years to < 18 Years of Age With AAV.

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Amgen
Study ID
NCT06321601
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The main objective of this study is to explore the efficacy of avacopan in participants affected by AAV.

Key Dates

Start date
Oct 22, 2024
Status verified
May 2026
Primary completion
Sep 26, 2028
Completion
Sep 26, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Avacopan
    Participants will receive avacopan twice-daily (BID) administered as oral tablets or liquid formula for 52 weeks.

Primary Outcome Measure

Proportion of Participants Achieving Disease Remission at Week 26 According to the Pediatric Vasculitis Activities Score (PVAS) [ Time Frame: Week 26 ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Emory UniversityAtlantaGeorgia30322-
Riley Hospital for ChildrenIndianapolisIndiana46202-
University of Minnesota Masonic Childrens Hospital Discovery ClinicMinneapolisMinnesota55454-
Cohen Children Medical CenterLake SuccessNew York11042-
University of North CarolinaChapel HillNorth Carolina27599-
Wake Forest University Health SciencesCharlotteNorth Carolina28203-
Akron Childrens HospitalAkronOhio44308-
Cleveland Clinic FoundationClevelandOhio44195-
University of Pittsburgh Medical Center Childrens Hospital of PittsburghPittsburghPennsylvania15224-
Texas Childrens HospitalHoustonTexas77030-

Find similar trials in Atlanta, GA

By research site
Emory University· Atlanta, GARiley Hospital for Children· Indianapolis, INUniversity of Minnesota Masonic Childrens Hospital Discovery Clinic· Minneapolis, MNCohen Children Medical Center· Lake Success, NYUniversity of North Carolina· Chapel Hill, NCWake Forest University Health Sciences· Charlotte, NC

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