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Complement Inhibitor
Danicopan for Age-Related Macular Degeneration
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
Vaccination for Neisseria meningitidis
Presentation of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in at least 1 eye
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 52 and week 104
Awards & highlights
Study Summary
This trial is testing a new drug for age-related macular degeneration. There are 4 groups of patients, each taking different doses of the drug or a placebo. The trial will last 104 weeks, with follow up 30 days after the last dose.
Who is the study for?
This trial is for individuals with a condition called Geographic Atrophy (GA) that's due to Age-Related Macular Degeneration (AMD). Participants must have received a specific vaccination, be able to consent, and have GA lesions outside the central part of their retina. People are excluded if they've had other treatments or studies for GA in the last 3 months, have complement deficiencies, certain medical conditions deemed risky by the investigator, previous stem cell/gene therapy for eye conditions, active ocular diseases affecting vision assessment or allergies to study drug components.Check my eligibility
What is being tested?
The study tests different doses of Danicopan (100 mg twice daily, 200 mg twice daily, and 400 mg once daily) against a placebo to see which is more effective and safe over two years. It aims to find out how well Danicopan works on GA secondary to AMD and monitors participants' reactions over time after taking it.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones may include allergic reactions like rashes or itching due to hypersensitivity; potential risks could also involve issues related to immune response given Danicopan targets complement pathways involved in inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been vaccinated against meningitis.
Select...
I have vision loss in one eye due to AMD.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 52 and week 104
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 52 and week 104
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 To Week 52 In The Square Root (sqrt) Of Total GA Lesion Area In The Study Eye As Measured By Fundus Autofluorescence (FAF)
Secondary outcome measures
Eye
Change From Baseline To Week 52 And Week 104 In Low Luminance Deficit (BCVA-LLVA) In The Study Eye
Change From Baseline To Week 52 And Week 104 In Monocular Best-corrected Visual Acuity (BCVA) Scores In The Study Eye As Assessed By The Early Treatment Diabetic Retinopathy Study (ETDRS) Chart
+7 moreSide effects data
From 2024 Phase 3 trial • 86 Patients • NCT0446946511%
Headache
9%
Nausea
7%
Diarrhoea
7%
Arthralgia
5%
Pain in extremity
5%
Alanine aminotransferase increased
5%
Hypertension
5%
Vomiting
5%
Pyrexia
4%
White blood cell count decreased
4%
Myalgia
4%
Aspartate aminotransferase increased
4%
Constipation
4%
Urinary tract infection
4%
Viral infection
4%
Oropharyngeal pain
4%
Rhinorrhoea
4%
Haemolysis
2%
Noninfective gingivitis
2%
Post procedural diarrhoea
2%
Splenomegaly
2%
Upper respiratory tract infection
2%
Flatulence
2%
Hypercholesterolaemia
2%
Chromaturia
2%
Neutropenia
2%
Pancreatitis
2%
Neutrophil count decreased
2%
Oedema peripheral
2%
Hepatic function abnormal
2%
Sinusitis
2%
Flushing
2%
Platelet count decreased
2%
Decreased appetite
2%
Liver disorder
2%
Hot flush
2%
Cholecystitis
2%
Leukopenia
2%
Anaemia
2%
Dry eye
2%
Abdominal pain upper
2%
Dyspepsia
2%
Stomatitis
2%
Jaundice
2%
Localised infection
2%
Cellulitis
2%
Contusion
2%
Blood bilirubin increased
2%
Blood pressure increased
2%
Bone pain
2%
Osteoarthritis
2%
Acne
2%
Rash maculo-papular
2%
Discoloured vomit
2%
Blood lactate dehydrogenase increased
2%
Lymphocyte count decreased
2%
SARS-CoV-2 test positive
2%
Chest discomfort
2%
Hepatic enzyme increased
2%
Fatigue
2%
COVID-19
2%
Proteinuria
2%
Cough
2%
Abdominal discomfort
2%
Fall
2%
Febrile nonhaemolytic transfusion reaction
2%
Post procedural contusion
2%
Post procedural haemorrhage
2%
Skin abrasion
2%
Thoracic vertebral fracture
2%
Dizziness
2%
Lethargy
2%
Hallucination
2%
Insomnia
2%
Epistaxis
2%
Sinus pain
2%
Salivary gland pain
2%
Peripheral swelling
100%
80%
60%
40%
20%
0%
Study treatment Arm
Danicopan
Placebo
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Danicopan: 400 mgExperimental Treatment1 Intervention
Participants will receive danicopan 400 mg qd during the masked Treatment Period. Once the optimal dose is identified, participants who have at least 52 weeks of treatment will be switched to the optimal dose for the remainder of the study.
Group II: Danicopan: 200 mgExperimental Treatment1 Intervention
Participants will receive danicopan 200 mg bid during the masked Treatment Period. Once the optimal dose is identified, participants who have at least 52 weeks of treatment will be switched to the optimal dose for the remainder of the study.
Group III: Danicopan: 100 mgExperimental Treatment1 Intervention
Participants will receive danicopan 100 mg bid during the masked Treatment Period. Once the optimal dose is identified, participants who have at least 52 weeks of treatment will be switched to the optimal dose for the remainder of the study.
Group IV: PlaceboPlacebo Group2 Interventions
Participants will receive matching placebo and will be re-randomized to one of the active treatment groups at Week 52, or to the optimal dose, if already identified.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Danicopan
2020
Completed Phase 3
~680
Find a Location
Who is running the clinical trial?
Alexion Pharmaceuticals, Inc.Lead Sponsor
252 Previous Clinical Trials
40,772 Total Patients Enrolled
Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
37,043 Total Patients Enrolled
AlexionLead Sponsor
246 Previous Clinical Trials
38,897 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been vaccinated against meningitis.I have been vaccinated for meningitis.I have advanced age-related macular degeneration in at least one eye.I have received stem cell or gene therapy for an eye condition.I have vision loss in one eye due to AMD.I am not allergic to the trial drug or its ingredients.My vision loss is not due to AMD.The affected area of your eye cannot be too close to the center of your vision.I do not have eye conditions that could affect my vision or interfere with the study.I have a complement system deficiency.I am able to understand and sign the consent form.I have had eye injections for blood vessel issues in my study eye.I haven't used any experimental or approved treatments for GA in my eye recently.I am able to understand and sign the consent form.I'm sorry, I cannot rewrite the criterion without additional information. Please provide me with more context or details.
Research Study Groups:
This trial has the following groups:- Group 1: Danicopan: 200 mg
- Group 2: Placebo
- Group 3: Danicopan: 100 mg
- Group 4: Danicopan: 400 mg
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.
Age-Related Macular Degeneration Patient Testimony for trial: Trial Name: NCT05019521 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any documented precedents to the Danicopan clinical trial?
"First studied in 2018, Danicopan has since undergone a total of 18340 trials. Currently, 3 inquiries into the medication are active with most occurring at Saint Petersburg, Florida's Clinical Study Site."
Answered by AI
Has this clinical experiment been conducted before?
"Since 2018, Danicopan has been subject to several rounds of clinical research. Alexion Pharmaceuticals sponsored the first experiment in that year which featured 12 subjects, leading to its Phase 2 drug approval soon after. Now with 3 ongoing experiments based out of 99 cities and 21 countries across the globe, this medication is being further explored through a variety of trials."
Answered by AI
Has Danicopan obtained certification from the FDA?
"Although there is some evidence of Danicopan's safety, as this is a Phase 2 trial, the score it was given by Power team on a scale from 1 to 3 was a 2. There are no reports supporting its efficacy yet."
Answered by AI
In what locations are participants engaging in this experiment?
"At this moment, 41 different medical clinics are registering patients for the trial. These include those in Saint Petersburg, Monroeville and Ottawa, as well as a multitude of other places. It is prudent to pick your closest centre if you plan on taking part in the study so that travel expenses can be minimized."
Answered by AI
Are there currently any opportunities to join this medical experiment?
"Clinicaltrials.gov reveals that this clinical experiment is presently recruiting volunteers, with the initial posting occurring on August 20th 2021 and a recent edit taking place on November 17th 2022."
Answered by AI
How many enrollees are currently accepted into this trial?
"Affirmative. Information from clinicaltrials.gov indicates that this medical study, first posted on August 20th 2021, is actively enrolling individuals into the trial. Approximately 332 participants are required to be recruited across 41 different locations."
Answered by AI
Who else is applying?
What state do they live in?
Colorado
Indiana
Florida
How old are they?
65+
What site did they apply to?
Clinical Study Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
Trying to halt [progression or even improve my vision, if possible. There was a Jacksonville, FL location on the first page but did not come up as an option on the survey.
PatientReceived 2+ prior treatments
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