A Study to Assess Subcutaneous Lirentelimab (AK002) in Atopic Dermatitis
- Conditions
- Atopic DermatitisMedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2022-001625-79-DE
- Lead Sponsor
- Allakos Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 130
Subjects are eligible for the study if all of the following criteria are met:
1) Subject is able to understand the information on the study, has the capacity to consent, and has provided written informed consent.
2) Male or female aged =18 and =80 years at the time of signing the ICF.
3) Chronic AD (as defined by the American Academy of Dermatology Consensus Criteria) (Eichenfield, 2014); 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.
6) EASI score of =16 at screening and at baseline.
7) Involvement of at least 10% or more of BSA at screening and at baseline.
8) An IGA score of 3 or above on a scale from 0–4 at screening and at baseline.
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.
12) Willing and able to comply with the study procedures and visit schedule including follow-up visits.
13) Female subjects must be either postmenopausal (defined as no menses for 12 months without an alternative medical cause) with FSH level >30 mIU/mL at screening or surgically sterile (tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 3 months, or if of childbearing potential, have a negative pregnancy test and agree to use a highly effective method of contraception as defined in this protocol or abstain from sexual activity, if compliant with preferred and usual lifestyle of the subject, from screening until the end of the study or for 120 days following the last dose of study drug, whichever is longer.
In the case of a postmenopausal female subject with FSH level =30 mIU/mL at screening, the subject will be required to have a negative serum pregnancy test during the screening period and will also be required to have a negative urine dipstick pregnancy test prior to dosing and at each study visit.
14) Male subjects with female partners of childbearing potential must agree to use a highly effective method of contraception as defined in this protocol or abstain from sexual activity from screening until the end of the study or for 120 days following the last dose of study drug, whichever is longer. All fertile men with female partners of childbearing potential should be instructed to contact the Investigator immediately if they suspect their partner might be pregnant (e.g., missed or late menstrual period) at any time during study participation.
Are the trial sub
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).
3) Use of any of the following treatments within 4 weeks prior to the baseline visit or any condition that in the opinion of the Investigator is likely to require such treatment(s) during the first 4 weeks of study treatment:
- Phototherapy for AD
- Immunosuppressive or immunomodulatory drugs, including but not limited to systemic calcineurin inhibitors (e.g., cyclosporin, tacrolimus), mTOR inhibitors (e.g., sirolimus, everolimus), anti-metabolites (e.g., azathioprine, methotrexate, 6-mercaptopurine, leflunomide, mycophenolate mofetil), alkylating agents (e.g., cyclophosphamide), eosinophil-depleting drugs (e.g., pramipexole), and systemic corticosteroids
- Oral JAK inhibitors within 8 weeks of the baseline visit (requires discussion with Allakos Medical Monitor prior to subject enrolling in study)
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
- TNF inhibitors (e.g., infliximab, adalimumab) and other biologics (e.g., dupilumab, omalizumab, etc.) within 5 half-lives if known or 8 weeks prior to the baseline visit, whichever is longer
5) Any use of topical corticosteroids, topical calcineurin inhibitors, topical JAK inhibitors (e.g., ruxolitinib), or topical PDE4 inhibitors (crisaborole) for the treatment of AD within 1 week prior to the baseline visit.
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.
12) A helminth parasitic infection diagnosed within 6 months prior to the date informed consent is obtained that has not been treated with or has failed to respond to standard-of-care therapy.
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.
18) Prior exposure to lirentelimab or known hypersensitivity to any constituent of the study drug.
19) Participation in a concurrent interventional study with the last intervention occurring within 30 days prior to study drug administration (or 90 days or 5 half-lives, whichever is longer, for biol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method