Efficacy and Safety of Stapokibart for Primary Cutaneous Amyloidosis (NCT07143864) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy and Safety of Stapokibart for Primary Cutaneous Amyloidosis
40 participantsStarted 2025-09-15
Plain-language summary
This trial is planned to investigate the efficacy and safety of Stapokibart (an IL-4 receptor antagonist) in patients with PCA.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
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Inclusion criteria
. Males or females aged 18 to 75 years, with a diagnosis of PCA confirmed by skin biopsy, and an IGA score of ≥3, a AASI score of ≥5, and a BSA involvement of ≥5%.
. Subjects who have received at least 4 weeks of mid-to-high potency or at least 2 weeks of very high potency topical corticosteroids (TCS) or an adequate course of systemic corticosteroids within the 6 months prior to screening, but with an inadequate response; or subjects who are unable to receive the above treatments due to adverse reactions or potential risks.
. Prior to the first dose, subjects must have used a moisturizer continuously for at least 1 week, once daily, and must continue to use it throughout the study period.
. Able to understand and complete study-related questionnaires.
. Able to read, understand, and are willing to sign the informed consent form.
. Willing and able to comply with study visits and related procedures.
. Women of childbearing potential must agree to use contraception (such as intrauterine devices, oral contraceptives, or condoms) during the study and for 6 months after the study ends; must have a negative serum pregnancy test within 7 days before the first dose and must not be breastfeeding; male subjects must agree to use contraception during the study and for 6 months after the study ends.
Exclusion criteria
What they're measuring
1
The percentage of subjects achieving AASI-75 at Week 16 of treatment
Timeframe: At the end of treatment at 16 weeks
Trial details
NCT IDNCT07143864
SponsorFirst Affiliated Hospital of Chongqing Medical University
. Use of any of the following treatments within 4 weeks prior to randomization: a. Immunosuppressants or immunomodulators, such as systemic corticosteroids, cyclosporine, mycophenolate mofetil, interferon gamma (IFN-γ), azathioprine, methotrexate, and Janus kinase (JAK) inhibitors; b. UV phototherapy; c. Systemic traditional Chinese medicine (TCM) treatment.
. Use of topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), TCM, or phosphodiesterase 4 (PDE-4) inhibitors within 2 weeks prior to randomization.
. Receipt of anti-IL-4R monoclonal antibodies, anti-IgE monoclonal antibodies, or other biologics within 12 weeks or 5 half-lives (whichever is longer) prior to randomization.
. Receipt of live attenuated vaccines within 12 weeks prior to randomization or planned vaccination during the study period.
. Use of antihistamines within 1 week prior to randomization (subjects who have been on a stable dose of antihistamines for at least 7 days prior to randomization and plan to continue during the study period may be included).
. Receipt of allergen-specific immunotherapy (desensitization therapy) within 6 months prior to randomization.
. Presence of any skin comorbidities that may interfere with study assessments, including but not limited to scabies, cutaneous T-cell lymphoma, psoriasis, etc.
. Previous receipt of at least 12 consecutive doses of anti-IL-4Rα or IL-13 monoclonal antibodies with inadequate clinical response (defined as failure to achieve AASI 50 during treatment).