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Complement Inhibitor

BCX9930 for Paroxysmal Nocturnal Hemoglobinuria (REDEEM-2 Trial)

Phase 2
Waitlist Available
Led By David J Kuter, MD, DPhil
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 from week 4 to week 12
Awards & highlights

REDEEM-2 Trial Summary

This trial will test whether a new drug is safe and effective for treating people with PNH who are not currently taking a complement inhibitor.

Who is the study for?
Adults over 18 with PNH who haven't had complement inhibitor therapy for at least a year can join this trial. They must weigh over 40 kg, have a PNH clone of ≥10%, hemoglobin ≤10.5 g/dL, and high lactate dehydrogenase levels. Participants need current vaccinations or agree to get them and cannot access other PNH treatments.Check my eligibility
What is being tested?
The study is testing BCX9930 alone against a placebo in patients with PNH who aren't on other complement inhibitors. The goal is to see if BCX9930 is effective and safe as the only treatment for controlling their condition.See study design
What are the potential side effects?
Specific side effects are not listed here, but generally, participants may experience reactions related to the immune system's response to the drug or placebo effect which could include headaches, nausea, or potential allergic reactions.

REDEEM-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My weight is at least 40 kg.
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I have been diagnosed with PNH.
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I cannot use or access standard complement inhibitor treatments.
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I haven't taken complement inhibitor therapy in the last year.

REDEEM-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 4 to week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 4 to week 12 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
Blood Transfusion
Percent change from baseline in lactate dehydrogenase
+1 more

REDEEM-2 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BCX9930 monotherapyExperimental Treatment1 Intervention
In Part 1, participants are randomized to 2:1 to receive BCX9930 monotherapy or placebo under double-blind conditions In Part 2, all participants receive open-label BCX9930 monotherapy
Group II: PlaceboPlacebo Group1 Intervention
In Part 1, participants are randomized to 2:1 to receive BCX9930 monotherapy or placebo under double-blind conditions

Find a Location

Who is running the clinical trial?

BioCryst PharmaceuticalsLead Sponsor
53 Previous Clinical Trials
4,475 Total Patients Enrolled
David J Kuter, MD, DPhilPrincipal InvestigatorMassachusetts General Hospital

Media Library

BCX9930 (Complement Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05116787 — Phase 2
Paroxysmal Nocturnal Hemoglobinuria Research Study Groups: BCX9930 monotherapy, Placebo
Paroxysmal Nocturnal Hemoglobinuria Clinical Trial 2023: BCX9930 Highlights & Side Effects. Trial Name: NCT05116787 — Phase 2
BCX9930 (Complement Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05116787 — Phase 2

Frequently Asked Questions

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

What risks do patients face when taking BCX9930 as a sole treatment?

"Based on our team's evaluation, BCX9930 monotherapy received a score of 2 as this is Phase 2 trial and there are preliminary data points indicating safety but none in regards to efficacy."

Answered by AI

Is the recruitment process for this clinical trial still active?

"Affirmative. As documented on clinicaltrials.gov, this trial is actively enrolling patients at one location and has been doing so since October 26th 2021. Currently there are 57 available positions for prospective participants."

Answered by AI

What is the uppermost capacity of participants in this experiment?

"Indeed, clinicaltrials.gov indicates that this research is actively enlisting participants. It was initially published on October 26th 2021 and last revised November 2nd 2022; it is aiming to recruit 57 individuals from one medical centre."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
BCX9930 for the Treatment of PNH in Subjects Not Receiving Other Complement Inhibitor Therapy
2021. "BCX9930 for the Treatment of PNH in Subjects Not Receiving Other Complement Inhibitor Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05116787.
~3 spots leftby May 2025
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