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DS-1211b for Pseudoxanthoma Elasticum
Phase 2
Waitlist Available
Research Sponsored by Daiichi Sankyo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have an established diagnosis of PXE
Male or female participants aged 18 to 75 years at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening (days -1 to -30) and at days 1, 15, 43, 84, 86-88, and 98 post-dose of 12-week treatment period
Awards & highlights
Study Summary
This trial was designed to study the safety and how well DS-1211b works in people with PXE. PXE is a rare disease that can cause blindness and other serious health problems.
Who is the study for?
This trial is for adults aged 18-75 with Pseudoxanthoma Elasticum (PXE), a rare disease affecting skin, eyes, and blood vessels. Participants must have confirmed PXE diagnosis, be fully COVID-19 vaccinated, and agree to use contraception if female. Excluded are those with certain bone diseases or recent fractures, changes in Vitamin D or bisphosphonate treatment within specific timeframes, severe kidney issues, pregnancy/breastfeeding women, and anyone who's been in another study recently.Check my eligibility
What is being tested?
The trial tests DS-1211b against a placebo to assess its safety and effects on the body (PD/PK) in individuals with PXE. The goal is to see if this drug can help manage symptoms related to vision problems and risks of heart or peripheral vascular diseases that come with PXE.See study design
What are the potential side effects?
While the side effects of DS-1211b are not detailed here, common clinical trial side effects may include reactions at the injection site, nausea, headaches, fatigue or allergic responses. Specific side effects will be monitored closely given that it's a new treatment under evaluation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with PXE.
Select...
I am between 18 and 75 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening (days -1 to -30) and at days 1, 15, 43, 84, 86-88, and 98 post-dose of 12-week treatment period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening (days -1 to -30) and at days 1, 15, 43, 84, 86-88, and 98 post-dose of 12-week treatment period
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Alkaline Phosphatase
Change from Baseline in Pharmacodynamic Parameter Inorganic Pyrophosphate (PPi) Levels
Change from Baseline in Pharmacodynamic Parameter Pyridoxal 5'-phosphate (PLP) Levels
+1 moreSecondary outcome measures
Pharmacokinetic Parameter Area Under the Plasma Concentration-time Curve (AUC)
Pharmacokinetic Parameter Maximum Concentration (Cmax)
Pharmacokinetic Parameter Time to Maximum Concentration (Tmax)
+1 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: DS-1211b middle doseExperimental Treatment1 Intervention
Participants who will be randomized to receive a DS-1211b tablet once daily for 12 weeks.
Group II: DS-1211b low doseExperimental Treatment1 Intervention
Participants who will be randomized to receive a DS-1211 tablet once daily for 12 weeks.
Group III: DS-1211b high doseExperimental Treatment1 Intervention
Participants who will be randomized to receive a DS-1211b tablet once daily for 12 weeks.
Group IV: PlaceboPlacebo Group1 Intervention
Participants who will be randomized to receive a placebo tablet once daily for 12 weeks.
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Who is running the clinical trial?
Daiichi SankyoLead Sponsor
392 Previous Clinical Trials
411,300 Total Patients Enrolled
1 Trials studying Pseudoxanthoma Elasticum
48 Patients Enrolled for Pseudoxanthoma Elasticum
Daiichi Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
415,232 Total Patients Enrolled
1 Trials studying Pseudoxanthoma Elasticum
48 Patients Enrolled for Pseudoxanthoma Elasticum
PXE InternationalOTHER
1 Previous Clinical Trials
48 Total Patients Enrolled
1 Trials studying Pseudoxanthoma Elasticum
48 Patients Enrolled for Pseudoxanthoma Elasticum
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidneys do not work well.I have used bisphosphonate in the last year or plan to use it during the study.I have planned elective surgery during the study period.I am not willing to use birth control.I have a bone condition that is not just weak bones without fractures.I have recently started or changed my Vitamin D dosage.I have a history of calcium crystal buildup in my joints.I have been diagnosed with hypophosphatasia.I have never been treated for high parathyroid hormone levels.Your alkaline phosphatase levels are lower than the normal range.Your heart takes longer than normal to recharge between beats.I have been diagnosed with PXE.I am between 18 and 75 years old.I have been taking more than 5 mg/day of Vitamin B6 for the last month and will continue during the study.I have had a bone fracture in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: DS-1211b low dose
- Group 2: DS-1211b middle dose
- Group 3: DS-1211b high dose
- Group 4: Placebo
Awards:
This trial has 0 awards, including: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.
In how many different medical clinics is this research being conducted today?
"This study is being conducted at 4 locations, 2 of which are in New york. The other two trial sites are based in Bethesda and Secaucus. There may be additional locations depending on where the patient enrolls."
Answered by AI
Are patients currently being accepted for this treatment program?
"That is correct. The website clinicaltrials.gov has the latest information on this trial, which is looking for 64 individuals at 4 different locations."
Answered by AI
What are the inclusivity criteria for this research project?
"This study is for 64 patients who currently suffer from pseudoxanthoma elasticum and meet the following additional requirements: Be of age 18-75, have given signed and dated informed consent, be vaccinated against coronavirus disease 2019 (COVID-19) as per current Center for Disease Control and Prevention guidelines."
Answered by AI
Does this research involve seniors as test subjects?
"This study is available to adults aged 18-75."
Answered by AI
How does DS-1211b high dose compare in danger to other drugs?
"DS-1211b high dose received a score of 2. This is due to the lack of available evidence supporting efficacy, despite some data affirming DS-1211b's safety."
Answered by AI
How many people are being signed up for this clinical trial?
"Yes, the clinical trial is still open and recruiting patients. According to the information on clinicaltrials.gov, the study was first posted on 10/20/2022 and was last updated on 11/2/2022. The research team hopes to enroll a total of 64 participants across 4 sites."
Answered by AI
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