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Complement Inhibitor

BCX9930 for Paroxysmal Nocturnal Hemoglobinuria (REDEEM-1 Trial)

Phase 2
Waitlist Available
Led By Austin G Kulasekararaj, MBBS, MD
Research Sponsored by BioCryst Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body weight ≥ 40 kg
Documented diagnosis of PNH
Timeline
Screening 3 weeks
Treatment Varies
Follow Up mean of values at weeks 12, 16, 20, and 24
Awards & highlights

REDEEM-1 Trial Summary

This trial will compare the new drug BCX9930 to the current standard of care for PNH, which is a C5 inhibitor. The trial will measure how well the drugs treat PNH and how safe they are.

Who is the study for?
Adults diagnosed with PNH who still have low hemoglobin levels despite being on C5 inhibitors like Eculizumab or Ravulizumab can join. They must be over 18, weigh at least 40 kg, and have up-to-date vaccinations against certain infections.Check my eligibility
What is being tested?
The trial is testing BCX9930 as a solo treatment for PNH to see if it's better than sticking with the usual C5 inhibitor therapy in controlling anemia for those not responding well enough to current treatments.See study design
What are the potential side effects?
Potential side effects of BCX9930 aren't detailed here but could include reactions similar to other drugs in its class such as headaches, nausea, or potential risk of infections due to immune system impact.

REDEEM-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My body weight is at least 40 kg.
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I have been diagnosed with PNH.
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I am on a stable treatment plan for my condition with C5 inhibitors.
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My PNH clone size is at least 10% and my hemoglobin is 10.5 g/dL or less.
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I am vaccinated or willing to get vaccinated against meningitis and pneumonia.

REDEEM-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~mean of values at weeks 12, 16, 20, and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and mean of values at weeks 12, 16, 20, and 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in hemoglobin
Secondary outcome measures
Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale score
Number of units of packed red blood cells transfused
Proportion of subjects who are transfusion-free

REDEEM-1 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BCX9930 monotherapyExperimental Treatment1 Intervention
In Part 1, participants are randomized 2:1 to receive BCX9930 monotherapy or continue with current C5 inhibitor In Part 2, all subjects receive BCX9930 monotherapy
Group II: Continued C5 inhibitor therapyActive Control2 Interventions
In Part 1, participants are randomized 2:1 to receive BCX9930 monotherapy or continue with current C5 inhibitor
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BCX9930
2020
Completed Phase 2
~170

Find a Location

Who is running the clinical trial?

BioCryst PharmaceuticalsLead Sponsor
53 Previous Clinical Trials
4,475 Total Patients Enrolled
Austin G Kulasekararaj, MBBS, MDPrincipal InvestigatorKing's College Hospital NHS Trust

Media Library

BCX9930 (Complement Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05116774 — Phase 2
Paroxysmal Nocturnal Hemoglobinuria Research Study Groups: BCX9930 monotherapy, Continued C5 inhibitor therapy
Paroxysmal Nocturnal Hemoglobinuria Clinical Trial 2023: BCX9930 Highlights & Side Effects. Trial Name: NCT05116774 — Phase 2
BCX9930 (Complement Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05116774 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has a similar research effort been attempted before?

"At present, there are 24 active clinical trials for BCX9930 in 45 nations and 240 towns. Alexion Pharmaceuticals' first trial of this compound launched in 2016 with 270 participants; since then, another 48 tests have been conducted which culminated in its Phase 3 drug endorsement stage."

Answered by AI

What risks are associated with the use of BCX9930?

"Considering that BCX9930 is in Phase 2 trials, and clinical data only supports safety rather than efficacy, our team at Power evaluated it's security as a score of 2."

Answered by AI

What conditions have been effectively addressed with BCX9930?

"BCX9930 is generally used to treat complement inhibitor naive, though it has seen success in targeting myasthenia gravis, generalized neuromyelitis optica and hemolysis."

Answered by AI

What is the capacity of this clinical trial's participant enrollment?

"Affirmative. The clinicaltrials.gov database affirms that this trial, which was first published on December 6th 2021, is currently seeking participants. A total of 81 individuals need to be enrolled from a single medical facility."

Answered by AI

Could you provide insight into previous experiments utilizing BCX9930?

"Currently, there are 24 active trials related to BCX9930 with 18 of them in the Phase 3 stage. While a handful of these clinical studies for BCX 9930 take place within Whittier, California, over 1273 medical centres worldwide have launched clinical tests concerning this drug."

Answered by AI

Are there any vacancies left in this clinical experiment?

"Affirmative. On clinicaltrials.gov, the details reveal that this trial is currently enrolling applicants and was launched on December 6th 2021 with its most recent amendment being made November 2nd 2022. 81 individuals are accepted at a single site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
BCX9930 for Treatment of PNH in Subjects With Inadequate Response to C5 Inhibitor Therapy
2021. "BCX9930 for Treatment of PNH in Subjects With Inadequate Response to C5 Inhibitor Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05116774.
~4 spots leftby Apr 2025
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