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Monoclonal Antibodies
Nemolizumab for Atopic Dermatitis
Phase 2
Waitlist Available
Research Sponsored by Galderma R&D
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 (week 0) and week 10: pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 72 and 120 hours post-dose'
Awards & highlights
Summary
This trial is testing nemolizumab, a medication, to see how it affects the body's ability to process other drugs. Nemolizumab has been previously studied for its effectiveness in treating atopic dermatitis. The study focuses on adults with moderate to severe atopic dermatitis, a skin condition. Researchers want to understand if nemolizumab changes how these patients' bodies handle a mix of common medications.
Who is the study for?
Adults with moderate-to-severe atopic dermatitis covering at least 10% of their body, an EASI score >=16, and a history of poor response to topical treatments can join. They must not weigh less than 45 kg, have poorly controlled asthma or recent severe exacerbations, be current smokers, or have certain infections including COVID-19 recently.
What is being tested?
The trial is testing the effects of Nemolizumab on how the body processes a mix of drugs that are markers for CYP450 enzyme activity. It aims to understand if Nemolizumab alters the breakdown of these drugs in adults with moderate-to-severe atopic dermatitis.
What are the potential side effects?
Potential side effects may include reactions related to immune system changes such as inflammation in various organs. Specific side effects will depend on how Nemolizumab interacts with enzymes that break down other medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (week 0) and week 10: pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 72 and 120 hours post-dose'
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 0) and week 10: pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 72 and 120 hours post-dose'
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change of Area Under the Concentration-time Curve from Time Zero to Infinity (AUC[0-infinity]) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment
Change of Area Under the Concentration-time Curve from Time Zero to the Time of the Last Measurable Concentration (AUC [0-last]) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment
Maximum Observed Plasma Concentration (Cmax) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment
Secondary study objectives
Incidence of Adverse Events (AEs)
Severity of Adverse Events (AEs)
Trial Design
1Treatment groups
Experimental Treatment
Group I: CYP 450 Substrates plus NemolizumabExperimental Treatment2 Interventions
Participants will receive 1 single oral dose of selected, commercially available, cytochrome P450 substrates (CYP450-S) on Day 1 and after a 1-week washout period, participants will receive a 60 milligram (mg) loading dose of nemolizumab via 2 consecutive subcutaneous (SC) 30-mg injections at the Week 1 visit, followed by a single 30-mg injection once in every 4 weeks (Q4W) at Week 5 and Week 9. Participants will receive a second oral dosing of CYP450-S at Week 10.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nemolizumab
2021
Completed Phase 3
~2750
CYP 450 Substrates
2021
Completed Phase 2
~20
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Who is running the clinical trial?
Galderma R&DLead Sponsor
300 Previous Clinical Trials
60,447 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You weigh less than 45 kilograms (about 99 pounds).You have been hospitalized for a severe asthma attack in the past year.Your asthma has not been well-controlled in the last 3 months.You have tested positive for hepatitis B, hepatitis C, or HIV.You need extra medication to manage your condition during the screening or treatment period.You have eczema that covers at least 10% of your body.You are currently smoking.You have chronic obstructive pulmonary disease or chronic bronchitis.Your eczema is very severe, with a score of 16 or higher on two separate visits.You have a moderate to severe skin condition based on the doctor's assessment.Your ability to blow air out of your lungs is less than 80% of what's expected for someone your age and size.You have active or hidden tuberculosis.You have had chronic atopic dermatitis for at least 2 years and it has been confirmed by a dermatologist according to specific criteria.You have taken certain medications that affect specific enzymes in the body within the past two weeks.If you have a history of asthma, your asthma control test score is 19 or lower.You have taken certain medications like Midazolam, Omeprazole, Warfarin Sodium, and Metoprolol Tartrate within 2 weeks before the screening.You cannot take the medications used in this study for medical reasons.Your international normalized ratio (INR) is higher than 1.5.You have taken biologic medications or their similar drugs within 8 weeks before the screening.You have a history of allergic reactions or intolerance to certain medications and their ingredients.You have consumed certain foods or drinks, like grapefruit or broccoli, or charbroiled meats, within a week before the study starts.You have a high itchiness score at both the screening and baseline visits.You have tried topical medications for your condition in the last 6 months, but they did not work well enough.You have a skin condition that could interfere with the study.You had a skin infection or any other infection that needed antibiotic, antiviral, antiparasitic, or antifungal treatment within the specified timeframes. You also had a confirmed or suspected COVID-19 infection within the specified timeframe. You can be screened again once the infection is gone.
Research Study Groups:
This trial has the following groups:- Group 1: CYP 450 Substrates plus Nemolizumab
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.
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