A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)

Part of paid clinical trials in San Francisco, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT04861259
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Atypical Hemolytic Uremic Syndrome

Eligibility Criteria

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

Interventions

  • Crovalimab — DRUG
    Crovalimab will be administered at a dose of 1000 milligrams (mg) intravenous (IV) (for participants with body weight at least 40 (\>=) and up to 100 kilograms (kg) or 1500 mg IV (for participants with body weight \>=100kg) on Week 1 Day 1. On Week 1 Day 2 and on Weeks 2, 3 and 4, it will be administered at a dose of 340 mg subcutaneously (SC). On Week 5 and every 4 weeks (Q4W) thereafter, it will be administered at a dose of 680 mg SC (for participants with body weight \>= 40kg to \<100kg) or 1020 mg SC (for participants with body weight \>=100kg).

Study Details

This study aims to evaluate the efficacy and safety of crovalimab in adult and adolescent participants with aHUS.

Key Dates

Start date
Oct 22, 2021
Status verified
Apr 2026
Primary completion
Oct 9, 2025
Completion
Aug 20, 2029

Study Design

Enrollment
83 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Crovalimab
    Participants will be enrolled in three cohorts: \[1\] Naive Cohort - participants who have not been previously treated with complement inhibitor therapy; \[2\] Switch Cohort - participants who switch to crovalimab from another Complement Component 5 (C5) inhibitor and \[3\] C5 Single Nucleotide Polymorphism (C5 inhibitor) Cohort - participants with documented C5 polymorphism.

Primary Outcome Measure

Percentage of Participants with Complete Thormbotic Microangiopathy Response (cTMAr) [ Time Frame: Baseline up to Week 25 (after 24 weeks on treatment) ]

Locations (6)

FacilityCityStateZIPSite coordinators
Univ of CA San FranciscoSan FranciscoCalifornia94143-
Children's Hospital ColoradoAuroraColorado80045-
Emory Children's CenterAtlantaGeorgia20010-
Washington UniversitySt LouisMissouri63110-
The Ohio State University Wexner Medical CenterColumbusOhio43212-
UT Health Science CenterSan AntonioTexas78229-

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Univ of CA San Francisco· San Francisco, CAChildren's Hospital Colorado· Aurora, COEmory Children's Center· Atlanta, GAWashington University· St Louis, MOThe Ohio State University Wexner Medical Center· Columbus, OHUT Health Science Center· San Antonio, TX

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