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NM26-2198 for Atopic Dermatitis/Eczema If indeed Alzheimer's was meant to be part of this study, please provide clarification so I can give you an accurate title reflecting that condition
Phase 1
Recruiting
Research Sponsored by Numab Therapeutics AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of chronic AD
Atopic lesions cover ≥10% of body surface area (BSA)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose on day 1 through day 85
Awards & highlights
Study Summary
This trial tests the safety, side effects, and how the body handles a drug given by injection to people with moderate to severe Alzheimer's.
Who is the study for?
Adults aged 18-55 with moderate-to-severe atopic dermatitis (AD) covering ≥10% of their body, who are not pregnant or breastfeeding and agree to use contraception. Participants must have specific scores on AD severity scales and be free from certain medications and conditions that could affect the trial results.Check my eligibility
What is being tested?
The trial is testing NM26-2198, a new medication for AD given by injection under the skin. It's compared against a placebo in healthy people and those with AD to see how safe it is, how the body processes it, and if it causes any immune reactions.See study design
What are the potential side effects?
Potential side effects include reactions at the injection site, general discomfort or changes in skin condition due to treatment. Since this is an investigational study, there may be unknown risks or side effects associated with NM26-2198.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with chronic Alzheimer's disease.
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My skin condition affects more than 10% of my body.
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I am a male willing to use double barrier contraception or abstain from sex and sperm donation during the study.
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My pain level is 4 or higher on a scale of 0-10.
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I use over-the-counter skin moisturizer daily.
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I am between 18 and 55 years old.
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My weight is between 45 kg and 100 kg, and my BMI is between 18.0 and 30.0.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-dose on day 1 through day 85
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose on day 1 through day 85
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of participants with Treatment Emergent Adverse Events (TEAEs) [MAD]
Percentage of participants with Treatment Emergent Adverse Events (TEAEs) [SAD]
Secondary outcome measures
Mean ADA titers [MAD]
Mean ADA titers [SAD]
Percentage of subjects developing treatment-emergent anti-drug antibodies (ADAs) [MAD]
+28 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: NM26-2198Experimental Treatment1 Intervention
NM26-2198 10mg, 50mg, 150mg, 300mg, 400mg, 600mg, and 900mg for SC injection in HVs on Day 1 (SAD Part A); NM26-2198 150mg, 300mg, and 600mg for SC injection in patients with AD (MAD Part B); NM26-2198 150mg and 300mg for SC injection in HVs on Days 1, 8, 15, and 22 (MAD Part C)
Group II: PlaceboPlacebo Group1 Intervention
Placebo (for NM26-2198) for subcutaneous (SC) injection in healthy volunteers (HVs) on Day 1 (SAD Cohorts) and on Days 1, 8, 15, and 22 (MAD Cohorts)
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Kaken Pharmaceutical Co., Ltd.UNKNOWN
Numab Therapeutics AGLead Sponsor
2 Previous Clinical Trials
232 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with chronic Alzheimer's disease.My skin condition affects more than 10% of my body.I have a current infection needing specific treatments.I am a male willing to use double barrier contraception or abstain from sex and sperm donation during the study.I haven't taken sedatives, steroids, chemotherapy drugs, or strong immune system medications recently.I do not have a significant medical history or current infections like COVID-19, Hepatitis B/C, or HIV.I am not pregnant, not breastfeeding, and willing to use contraception or abstain from sex.Your EASI score is 16 or higher.I only use medication occasionally, except for paracetamol.I have a skin condition that is not AD and could affect the study.I have recently received immunoglobulin or blood products.I have recently used prescription skin creams or moisturizers.I do not have significant abnormal lab results or positive tests for COVID-19, Hepatitis B/C, or HIV.You are not of Asian descent, and none of your grandparents or parents are Japanese or of Japanese descent.I am not pregnant, breastfeeding, and if able to bear children, I am using birth control as per the study's requirements.My pain level is 4 or higher on a scale of 0-10.I use over-the-counter skin moisturizer daily.Your vIGA-AD™ score is 3 or higher.I have AD and need ongoing eye steroid treatment due to recent eye problems.You have important heart rhythm problems or a history of them.I am between 18 and 55 years old.My weight is between 45 kg and 100 kg, and my BMI is between 18.0 and 30.0.I have not taken dupilumab, tralokinumab, lebrikizumab, nemolizumab, or similar drugs recently.I have long-term itching not caused by atopic dermatitis.I am 18 years old or older.You have had allergic reactions to biological drugs in the past.
Research Study Groups:
This trial has the following groups:- Group 1: NM26-2198
- Group 2: 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.
What implications does the use of NM26-2198 10 mg have for human health?
"Unsurprisingly, NM26-2198 10 mg earned a score of 1 due to its lack of safety and efficacy data associated with Phase 1 trials."
Answered by AI
What is the size of the cohort receiving this clinical trial treatment?
"Right. Clinicaltrials.gov offers evidence that this medical trial, which was first announced on May 10th 2023, is actively enrolling participants. This trial seeks to enrol 102 patients from one clinical centre."
Answered by AI
Are there any remaining vacancies to be filled for this research effort?
"Yes, the clinical trial is currently accepting participants. Initially posted in May 10th 2023 and recently edited on May 5th 2023 , this study needs 102 volunteers to be recruited from one medical site."
Answered by AI
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