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ALXN1820 for Sickle Cell Disease (PHOENIX Trial)
Phase 2
Waitlist Available
Research Sponsored by Alexion Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through day 211 (cohorts 1 and 2) and day 169 (optional cohort 3)
Awards & highlights
PHOENIX Trial Summary
This trial will test a new medicine's safety and how well it works for people with Sickle Cell Disease.
Who is the study for?
Adults with Sickle Cell Disease (HbSS, or HbSβ0-thalassemia) weighing at least 40 kg and having a hemoglobin level between 5.5 and 10 g/dL can join. They must be on stable hydroxyurea doses if applicable, vaccinated against certain infections, not planning major treatment changes, without severe kidney issues or recent transfusions/infections, and not pregnant.Check my eligibility
What is being tested?
The trial is testing the safety of ALXN1820 given under the skin to adults with Sickle Cell Disease. It aims to understand how well it's tolerated and its effects on the body (pharmacokinetics/dynamics).See study design
What are the potential side effects?
While specific side effects for ALXN1820 are not listed here, common risks may include reactions at injection site, potential allergic responses due to ingredients like polysorbate 80, and general discomfort.
PHOENIX Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through day 211 (cohorts 1 and 2) and day 169 (optional cohort 3)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through day 211 (cohorts 1 and 2) and day 169 (optional cohort 3)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Secondary outcome measures
Change From Baseline Complement Alternative Pathway (CAP) Activity Through Day 211 (Cohorts 1 and 2) and Day 169 (Optional Cohort 3)
Change From Baseline in Hemoglobin Level at Week 12 (Cohorts 1 and 2)
Change From Baseline in Hemopexin at Week 12 (Cohorts 1 and 2)
+5 morePHOENIX Trial Design
3Treatment groups
Experimental Treatment
Group I: ALXN1820 600 mg once every 4 weeksExperimental Treatment1 Intervention
Participants will receive 600 mg once every 4 weeks (Q4W).
Group II: ALXN1820 300 mg once weeklyExperimental Treatment1 Intervention
Participants will receive 300 milligrams (mg) once weekly (QW).
Group III: ALXN1820 300 mg once every 2 weeks (Optional cohort)Experimental Treatment1 Intervention
Participants will receive 300 mg once every 2 weeks (Q2W).
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Who is running the clinical trial?
Alexion Pharmaceuticals, Inc.Lead Sponsor
252 Previous Clinical Trials
41,107 Total Patients Enrolled
AlexionLead Sponsor
246 Previous Clinical Trials
39,232 Total Patients Enrolled
Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
37,378 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a serious infection in the last 14 days.I haven't taken complement inhibitors in the last 6 months.I plan to start, stop, or change my hydroxyurea dose during the study.I have taken Voxelotor or Crizanlizumab in the last 60 days.My vaccinations for Hib and pneumonia are current as per guidelines for sickle cell disease.I have been diagnosed with sickle cell disease.I have received a blood transfusion within the last 60 days or am on chronic transfusion.I've had between 1 and 10 pain crises in the last year.I have been vaccinated against meningitis at least 14 days before treatment, or within the last 3 years.I do not have any serious health issues that could increase my risk in the study.My kidney function is severely impaired or I am on long-term dialysis.I have had cancer before, but it was either skin cancer (not melanoma) or cervical cancer that hasn't come back in 5 years.My weight is at least 40 kg.I have been on a stable dose of hydroxyurea for at least 3 months.I am allergic to some ingredients in ALXN1820, like polysorbate 80.I am currently being treated with a medication to help increase my red blood cells.I have not been in more than one study for a monoclonal antibody, or any in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: ALXN1820 300 mg once weekly
- Group 2: ALXN1820 600 mg once every 4 weeks
- Group 3: ALXN1820 300 mg once every 2 weeks (Optional cohort)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned ALXN1820 300 mg as a once-weekly dosage?
"Our team has assessed that ALXN1820 300 mg once weekly elicits a safety score of 2 on the scale. This is due to its position as an experimental drug in Phase 2, which suggests there are some data points supporting safety but not efficacy."
Answered by AI
Is the age limit for participating in this clinical experiment restricted to those below fifty years?
"This clinical trial has a narrow age range of 18-65 years old, but there are additional studies specifically tailored to younger and older individuals totaling 206 trials."
Answered by AI
Is it possible for me to partake in this experiment?
"All candidates should possess a confirmed case of sickle cell anemia and be between 18-65 years old to qualify for this study. There are 30 total spots available in the clinical trial."
Answered by AI
Are there open enrollments for this medical research endeavor?
"Affirmative. Clinical trials' database confirms that this research is currently looking for volunteers, with the trial initially published on February 22nd 2023 and subsequently edited on March 8th 2023. The study needs to recruit 30 individuals from a single medical centre."
Answered by AI
What is the population size for this research endeavor?
"Affirmative. Clinicaltrials.gov attests that recruitment for this medical experiment, which debuted on February 22nd 2023, is ongoing. The trial requires thirty participants from a single research site."
Answered by AI
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