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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
Study Summary
This trial looks at how a new drug affects the levels of other drugs in the body in people with moderate to severe atopic dermatitis.
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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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
Find a Location
Who is running the clinical trial?
Galderma R&DLead Sponsor
298 Previous Clinical Trials
60,314 Total Patients Enrolled
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA green-lit Nemolizumab for public use?
"While there is some evidence to support its safety from Phase 2 clinical trials, there is no data currently pointing to nemolizumab's efficacy."
Answered by AI
How many people are allowed to participate in this research project?
"This study requires 25 participants that match the given inclusion criteria. These patients can visit either of two locations, 9923 Galderma Investigational Site in Miami, Florida or 9954 Galderma Investigational Site in Hallandale Beach, Texas."
Answered by AI
At how many hospitals or other medical facilities is this experiment being conducted?
"Patients can enrol at the Galderma Investigational Site in Miami, Florida; Hallandale Beach, Texas; Austin, California; or any of the other 5 clinical trial locations."
Answered by AI
Could you explain how this trial is innovative?
"Currently, there are 10 ongoing clinical trials for the use of Nemolizumab in 237 cities across 25 countries. The first study was completed in 2019 and sponsored by Galderma R&D. This phase 3 drug approval process included 750 participants. In the 2 years since the initial study 5 more have been completed."
Answered by AI
Are we currently looking for participants in this trial?
"Yes, the clinicaltrials.gov website currently lists this trial as recruiting patients. This study was first posted on May 24th, 2021 and was updated most recently on August 31st, 2022. The research is looking for 25 participants from 5 different sites."
Answered by AI
What other scientific research has been conducted on Nemolizumab?
"Nemolizumab was first researched in 2019 by Galderma at site 6021. Up to this point, there have been 5 completed studies with 10 more currently active trials; a large proportion of these are based in Miami, Florida."
Answered by AI
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