Summary: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Lirentelimab in Adult Subjects with Moderate-to-Severe Atopic Dermatitis Inadequately Controlled by Topical Treatment.
Duration: Study treatment will be administered subcutaneously every two weeks for 12 weeks beginning at randomization. Subjects will be observed for at least 1 hour after each injection.
Following the double-blind period of the study, subjects will be given the option of entering the open label extension (OLE) period of the study, contingent on meeting certain study criteria. Subjects will receive 7 doses of 300 mg study drug during the OLE period.
The total study duration for each subject in the double-blind period of the study will be approximately 7 months. If a subject chooses to enter the OLE period, the total study duration will be approximately 9 months, which includes: • A screening period of approximately 2 weeks prior to study drug administration. • A treatment period of 12 weeks (administration of study drug or placebo every 2 weeks for 7 doses). An optional open-label period of 12 weeks (administration of study drug every 2 weeks for 7 doses). • A follow-up period of 12 weeks after the last dose of study drug in the OLE period. Subjects who do not enter the OLE period of the study will be followed for 12 weeks after the last dose in the double-blind period of the study.
Inclusion Criteria: Subjects might be eligible to participate if they meet the below criteria**1) Male or female aged ≥18 and ≤80 years at the time of signing the ICF.
3) Medically diagnosed moderate to severe chronic AD that has been present for at least 3 years before screening visit.
4) Documented recent history of inadequate response to treatment with topical medications such as topical corticosteroids, calcineurin inhibitors, JAK inhibitors, or PDE4 inhibitors (crisaborole) for at least 4 weeks in the 6 months prior to screening, or subjects for whom these topical treatments are otherwise medically inadvisable (e.g., because of side effects or safety risks). 5) Subjects who are biologic-naïve or biologic-exposed. Biologic-exposed includes subjects who have demonstrated secondary loss of response, intolerance, or lack of access to biologics due to economic reasons.
9) The subject should have applied a stable dose of non-medicated, non-prescription, topical emollient at least twice daily for 7 consecutive days immediately before the baseline visit.
10) Willing to apply a stable dose of non-medicated, non-prescription, topical emollient, as recommended by the Investigator at least twice daily for the duration of the study, if not already on an emollient at the time of screening.
11) Commitment to remain on the same dose(s) of AD medication(s), including topical emollients, for the entire duration of study participation unless dose modification is due to unforeseen medical necessity.
13) Non-sterile female and male subjects must be willing to comply with study requirements regarding contraceptives during their enrollment and follow up period of this research study.
Exclusion Criteria: Subjects will be excluded from the study if they meet any of the following criteria**1) Current use of biologics for any indication.
2) Demonstrated lack of primary response to treatment with a biologic for the treatment of AD defined as no response to treatment despite complete adherence to the prescribed regimen for at least 3 months (primary non-responders).
4) Treatment with biologics: − Any cell-depleting agents including but not limited to rituximab; within 6 months prior to the baseline visit, or until lymphocyte count returns to normal, whichever is longer − Other biologics (e.g., dupilumab, omalizumab, etc.) within 5 half-lives if known or 8 weeks prior to the baseline visit, whichever is longer.
6) Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the screening visit.
7) Treatment with chemotherapy or radiotherapy in the preceding 6 months.
8) Presence of skin comorbidities/concomitant conditions that may interfere with study assessments or interpretation of study results.
9) Planned or anticipated use of any prohibited medication.
10) History of malignancy except carcinoma in situ in the cervix, early stage prostate cancer, or non-melanoma skin cancers.
11) Any disease, condition (medical or surgical), or cardiac abnormality that in the opinion of the Investigator would place the subject at increased risk.
13) Evidence of active hepatitis B or C at screening based on serology.
14) Evidence of active HIV infection at screening based on serology.
15) Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study. 16) Presence of an abnormal screening laboratory value considered to be clinically significant by the Investigator.
17) Known or suspected history of alcohol, drug, or other substance abuse or dependence that in the opinion of the Investigator may interfere with study participation or assessments.
20) Subjects who weigh <40 kg at screening.
21) Any other reason that in the opinion of the Investigator or the Medical Monitor makes the subject unsuitable for enrollment.
**This list is incomplete, the study coordinator can review a comprehensive list with subject during our prescreening process.