Efficacy and Safety of Stapokibart for Primary Cutaneous Amyloidosis

NCT07143864 | Not Yet Recruiting

• 1 other identifier: CQMU-2025-215
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This trial is planned to investigate the efficacy and safety of Stapokibart (an IL-4 receptor antagonist) in patients with PCA.

Conditions

Primary Cutaneous Amyloidosis

Keywords

primary cutaneous amyloidosis; Stapokibart

Outcome Measures

Primary Outcomes (1)

• The percentage of subjects achieving AASI-75 at Week 16 of treatment

  AASI: Amyloidosis Area and Severity Index. The minimum and maximum values: 0-72. Higher scores mean more serious situations. AASI-75: A 75% or greater improvement from baseline in the AASI. The minimum and maximum values: 0%-100%. Higher scores mean a better outcome.

  At the end of treatment at 16 weeks

Secondary Outcomes (9)

• The percentage of subjects with a weekly average reduction of≥4 points in PP-NRS score at Week 16 of treatment compared to baseline

  At the end of treatment at 16 weeks

• The percentage of subjects with an IGA score of 0 or 1 and a reduction of≥2 points compared to baseline.

  At the end of treatment at 16 weeks

• The percentage of subjects achieving AASI-50 compared to baseline.

  At the end of treatment at 16 weeks

• The percentage of subjects with a weekly average reduction of≥3 points in PP-NRS score compared to baseline

  At the end of treatment at 16 weeks

• Change rates in BSA involvement compared to baseline.

  At the end of treatment at 16 weeks

Other Outcomes (1)

• Safety Endpoints:Including the occurrence of AEs(Adverse Events),and abnormalities in laboratory tests,physical examinations,and vital signs.

  At the end of treatment at 16 weeks

Study Arms (2)

Stapokibart

EXPERIMENTAL

Biological: Stapokibart

Placebo

PLACEBO COMPARATOR

Other: Placebo drug

Interventions

Stapokibart BIOLOGICAL

A humanized monoclonal antibody that targets the interleukin (IL)-4 receptor subunit alpha

Stapokibart

Placebo drug OTHER

Placebo drugs without Stapokibart

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Presence of any other significant medical history that the investigator deems would pose a risk to the subject's safety or be poorly controlled if the subject participates in the study, in addition to PCA.
• History of known or suspected immunosuppression (immunodeficiency), including a history of invasive opportunistic infections (such as histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis), even if the infection has resolved; or unusual frequency, recurrence, or chronicity of infections (at the investigator's discretion).
• Subjects with any type of active malignancy or a history of malignancy (except for cervical cancer that has been cured for more than 5 years prior to the screening period, or non-metastatic squamous cell carcinoma of the skin, basal cell carcinoma, and papillary thyroid cancer).
• Presence of active Mycobacterium tuberculosis infection.
• Subjects with severe liver or kidney function impairment during the screening period, such as aspartate aminotransferase or alanine aminotransferase \>2 times the upper limit of normal (ULN), total bilirubin \>1.5 times ULN, serum creatinine \>1.2 times ULN, etc.
• Presence of active hepatitis during the screening period, or positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) and HBV-DNA, or positive for hepatitis C virus (HCV) antibody and HCV-RNA.
• Positive for HIV antibody during the screening period, or history of HIV infection.

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

MeSH Terms

Conditions

Amyloidosis, Primary Cutaneous

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Dermatology, The First Affiliated Hospital of Chongqing Medical University

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 27, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 27, 2025

Record last verified: 2025-08