Atopic Dermatitis (Galderma, 60 Weeks)
Sadick Research Group is conducting a clinical study assessing a new therapy for treating atopic dermatitis
Gender: Male and Female
Minimum Age: 12 Years Old
Maximum Age: N/A
Facility Type: Outpatient
Stipend Range: $50
Study Length: Approximately 15 Months
This is a randomized, double-blind, placebo-controlled, multicenter, parallel-group study in adult and adolescent subjects with moderate-to-severe AD. Eligible subjects must have a documented history of inadequate response to topical AD medication(s). Subjects will receive injections of nemolizumab in addition to topical therapy.
Inclusion and Exclusion Criteria
1. Male or female subjects aged ≥ 12 years at the screening visit.
- Chronic AD that has been documented for at least 2 years before the screening visit, and confirmed according to American Academy of Dermatology Consensus Criteria (Appendix 1)2 at the time of the screening visit.
- EASI score ≥ 16 at both the screening and baseline visits.
- IGA score ≥ 3 (based on the 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% of body surface area (BSA) at both the screening and baseline visits.
- Peak (maximum) pruritus NRS score of at least 4.0 at the screening and baseline visit.Screening PP NRS score will be determined by a single PP NRS assessment (score ranging from 0 to 10) for the 24-hour period immediately preceding the screening visit.
Baseline PP NRS score will be determined based on the average of daily PP NRS scores (score ranging from 0 to 10) during the 7 days immediately preceding baseline (rounding is not permitted). A minimum of 4 daily scores out of the 7 days immediately preceding baseline is required for this calculation.
- Documented recent history (within 6 months before the screening visit) of inadequate response to topical medications (TCS with or without TCI). All subjects must demonstrate inadequate response to TCS. All subjects who have used TCI within 6 months of the screening visit, or for whom TCI is selected as background therapy for sensitive areas, must also demonstrate inadequate response to TCI. Acceptable documentation includes patient records with information on TCS (with or without TCI) prescription and treatment outcome, or written documentation of the conversation with the subject’s treating physician, if different than the investigator. If documentation is inadequate, subjects may be re-screened after such documentation is obtained.Inadequate response to TCS treatments (with or without TCI) is defined as:
7a. Failure to achieve or maintain remission or low disease activity (equivalent to IGA ≤ 2) despite treatment with a daily regimen of a medium- or high-potency TCS (with or without TCI), applied for at least 4 weeks or for the maximum duration per prescribing information;
7b. Requirement of a long-term treatment (> 4 weeks) with a high-potency TCS (with or without TCI) to achieve or maintain remission or low disease activity (equivalent to IGA ≤ 2);
7c. If documentation of inadequate response to topical treatments is not available, subjects with a documented recent course of systemic treatment or phototherapy for AD (within 6 months before the visit) will also be considered as inadequate responders to topical treatments.
- Agree to apply a moisturizer throughout the study from the screening visit; agree to apply authorized topical therapy from the screening visit and throughout the study as determined appropriate by the investigator.
- Female subjects of childbearing potential must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection, or to use an effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection. This criterion also applies to a prepubertal female subject who begins menses during the study.
Other Trial Details
- Physical exam and assessments of study condition to be provided at no cost by an experienced provider.
- No insurance necessary.
- Compensation will be provided at the end of study participation.