A research study for people with moderate to severe atopic dermatitis.

  • STATUS
    Recruiting
  • sponsor
    Allakos
Updated on 11 July 2022
corticosteroids
topical corticosteroid
crisaborole
topical agents

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 Treatments

Description

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.

Details
Condition Eczema (Atopic Dermatitis), Atopic Dermatitis, Dermatitis, Atopic
Clinical Study IdentifierTX303773
SponsorAllakos
Last Modified on11 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects might be eligible to participate if they meet the below criteria. This list is incomplete, the study coordinator can review a comprehensive list with subject during our prescreening process
Male or female aged ≥18 and ≤80 years at the time of signing the ICF
Medically diagnosed moderate to severe chronic AD that has been present for at least 3 years before screening visit
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)
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
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
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
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
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. This list is incomplete, the study coordinator can review a comprehensive list with subject during our prescreening process
Current use of biologics for any indication
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)
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
Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the screening visit
Treatment with chemotherapy or radiotherapy in the preceding 6 months
Presence of skin comorbidities/concomitant conditions that may interfere with study assessments or interpretation of study results
Planned or anticipated use of any prohibited medication
History of malignancy except carcinoma in situ in the cervix, early stage prostate cancer, or non-melanoma skin cancers
Any disease, condition (medical or surgical), or cardiac abnormality that in the opinion of the Investigator would place the subject at increased risk
Evidence of active hepatitis B or C at screening based on serology
Evidence of active HIV infection at screening based on serology
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
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
Subjects who weigh <40 kg at screening
Any other reason that in the opinion of the Investigator or the Medical Monitor makes the subject unsuitable for enrollment
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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