A Study to Assess the Effects of Nemolizumab on Cytochrome P450 Substrates in Participants With Moderate-to-Severe Atopic Dermatitis
NCT ID: NCT04562116
Last Updated: 2024-12-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
17 participants
INTERVENTIONAL
2021-12-08
2023-06-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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CYP 450 Substrates plus Nemolizumab
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.
Nemolizumab
Nemolizumab 30 mg will be administered as SC injections.
CYP 450 Substrates
CYP substrates (Caffeine, Warfarin Sodium, Midazolam, Omeprazole, and Metoprolol Tartrate) will administered orally at Week 0 (Day 1) and Week 10 as per the commercially available prescribing information.
Interventions
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Nemolizumab
Nemolizumab 30 mg will be administered as SC injections.
CYP 450 Substrates
CYP substrates (Caffeine, Warfarin Sodium, Midazolam, Omeprazole, and Metoprolol Tartrate) will administered orally at Week 0 (Day 1) and Week 10 as per the commercially available prescribing information.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eczema Area and Severity Index (EASI) score greater than or equal to (\>=) 16 at both the screening and baseline visits
* IGA score \>= 3 (based on the Investigator's Global Assessment \[IGA\] scale ranging from 0 to 4, in which 3 is moderate and 4 is severe) at both the screening and baseline visits
* AD involvement \>=10 percent (%) of body surface area (BSA) at both the screening and baseline visits
* Peak (maximum) pruritus numeric rating scale (PP NRS) score of at least 4.0 at both the screening and baseline visit
* Documented recent history (within 6 months before the screening visit) of inadequate response to topical medications (topical corticosteroid \[TCS\] with or without topical calcineurin inhibitor \[TCI\])
Exclusion Criteria
* Participants meeting 1 or more of the following criteria at screening or baseline: (a) Had an exacerbation of asthma requiring hospitalization in the preceding 12 months; (b) Reporting asthma that has not been well-controlled in the previous 3 months; (c) Asthma Control Test (ACT) \<= 19 (for those with a history of asthma); (d) Peak expiratory flow \< 80% of the predicted value
* Participants with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis
* Cutaneous infection within 1 week prior to the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 2 weeks prior to the baseline visit, or any confirmed or suspected coronavirus disease (COVID)-19 infection within 2 weeks before the screening or baseline visit. Participants may be rescreened once the infection has resolved. Resolution of COVID-19 infection can be confirmed by recovery assessment methods
* Requiring rescue therapy for AD during the screening period or expected to require systemic rescue therapy during the treatment period
* Positive serology results (hepatitis B surface antigen \[HBsAg\] or hepatitis B core antibody \[HBcAb\], hepatitis C antibody, or human immunodeficiency virus antibody) at the screening visit
* Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to Screening
* Known active or latent tuberculosis
* Treatment with Biologics and their biosimilars within 8 weeks from Screening
* Use of Phototherapy or tanning beds within 4 weeks from Screening
* Use of medication known as inducer, inhibitor, or competitive substrate of one or more of the following cytochrome (CYP) enzymes: CYP3A4/5, CYP2C19, CYP2C9, CYD2D6, and CYP1A2 within 2 weeks from Screening
* Treatment with Midazolam, Omeprazole, Warfarin Sodium, Metoprolol Tartrate within 2 weeks from Screening
* History of hypersensitivity or intolerance to CYP substrates and their excipients
* Participants for whom administration of the CYP substrates provided in this study is contraindicated or medically inadvisable
* Participants with international normalized ratio (INR) \> 1.5
* Consumption of any 1 or more of the following food items and/or beverages within 1 week prior to baseline: Grapefruit or grapefruit juice, apple or apple juice, orange or orange juice, lemons or lemon juice, limes or lime juice, cranberries or cranberry juice; Vegetables from the mustard green family (eg, broccoli, kale); Charbroiled meats; Beverages, foods, or drugs containing caffeine
* History of or current confounding skin condition
* Current smokers
18 Years
ALL
No
Sponsors
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Galderma R&D
INDUSTRY
Responsible Party
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Locations
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8894 Galderma Investigational Site
North Hollywood, California, United States
9954 Galderma Investigational Site
Hallandale, Florida, United States
9923 Galderma Investigational Site
Miami, Florida, United States
8030 Galderma Investigational Site
Raleigh, North Carolina, United States
8076 Galderma Investigational Site
Austin, Texas, United States
5952 Galderma Investigational Site
Sofia, , Bulgaria
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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RD.06.SPR.201593
Identifier Type: -
Identifier Source: org_study_id