Subcutaneous ALXN1830 in Adult Participants With Warm Autoimmune Hemolytic Anemia
NCT ID: NCT04956276
Last Updated: 2022-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2022-01-01
2024-07-31
Brief Summary
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This study will include 2 randomized, double-blind, placebo-controlled cohorts (Cohorts 1 and 2) to evaluate an 8-week treatment regimen, and an optional third open-label cohort (Cohort 3) to evaluate an alternative 12-week dosing regimen. Participants may continue participation in this study at the participant's and investigator's discretion in an open-label extension (OLE) period, consisting of monthly visits to observe participants for relapse, which will require going back on active treatment.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Cohort 1: ALXN1830/Placebo
Participants will be randomized 3:1 to receive ALXN1830 or placebo. Treatment will be received for 8 weeks followed by a follow-up period (no treatment) for 8 weeks. Once complete, participants may continue participation in the study at the participant's and investigator's discretion during the OLE period for up to 2 years inclusive of primary treatment period.
ALXN1830
Administered as an SC infusion.
Placebo
Administered as an SC infusion.
Cohort 2: ALXN1830/Placebo
Participants will be randomized 3:1 to receive ALXN1830 or placebo. Treatment will be received for 8 weeks followed by a follow-up period (no treatment) for 8 weeks. Once complete, participants may continue participation in the study at the participant's and investigator's discretion during the OLE period for up to 2 years inclusive of primary treatment period.
ALXN1830
Administered as an SC infusion.
Placebo
Administered as an SC infusion.
Cohort 3: ALXN1830
If initiated, participants will receive ALXN1830. Treatment will be received for 12 weeks followed by a follow-up period (no treatment) for 8 weeks. Once complete, participants may continue participation in the study at the participant's and investigator's discretion during the OLE period for up to 2 years inclusive of primary treatment period.
ALXN1830
Administered as an SC infusion.
Interventions
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ALXN1830
Administered as an SC infusion.
Placebo
Administered as an SC infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Failed or have not tolerated at least one prior WAIHA treatment regimen, for example, corticosteroids, rituximab, azathioprine, cyclophosphamide, cyclosporine, mycophenolate mofetil, danazol, or vincristine.
* Hemoglobin \< 10 g/dL and ≥ 6 g/dL at Screening.
* Positive direct antiglobulin test (Coombs) (IgG positive who are positive or negative for the presence of complement C3) at Screening.
* Evidence of active hemolysis including any one of the below:
* LDH \> upper limit of normal (ULN) or
* Haptoglobin \< lower limit of normal or
* Indirect bilirubin \> ULN
* Total IgG \> 500 mg/dL at Screening
* Platelet count ≥ 75 x 10\^9/liter (L)
* Absolute neutrophil count greater than 1.0 x 10\^9/L
Exclusion Criteria
* Human immunodeficiency virus (HIV) infection (positive HIV 1 or HIV 2 antibody test).
* Positive hepatitis B surface antigen or hepatitis C antibody test.
* Inability to travel to the clinic for specified visits during the Primary Treatment Period or fulfill the logistical requirements of study intervention administration.
18 Years
ALL
No
Sponsors
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Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Study Site
Riverside, California, United States
Countries
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Other Identifiers
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ALXN1830-WAI-202
Identifier Type: -
Identifier Source: org_study_id
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