Clinical trial NCT05326672: Phase III Clinical Study of Benvitimod Cream in the Treatment of Mild to Moderate Atopic Dermatitis
Official title: A Randomized, Double-blind, Multicenter, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Benvitimod Cream in the Treatment of Mild to Moderate Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Benvitimod Cream
Atopic Dermatitis
Topical Treatment
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Zhonghao Pharmaceutical
First posted: 2022-04-13
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, multicenter, placebo-controlled clinical Phase III study to evaluate the safety and efficacy of Benvitimod cream, 1% twice daily for the treatment of mild to moderate atopic dermatitis. Approximately 240 participants with mild to moderate atopic dermatitis will be enrolled and randomly divided into two groups in a 2:1 ratio. They will use either the Benvitimod cream or placebo at the skin with atopic dermatitis for 8 weeks.

Detailed description: This is a randomized, double-blind, multicenter, placebo-controlled clinical Phase III study to evaluate the safety and efficacy of Benvitimod cream, 1% twice daily for the treatment of mild to moderate atopic dermatitis. Approximately 240 participants with mild to moderate atopic dermatitis will be enrolled and randomly divided into two groups in a 2:1 ratio. They will use either the Benvitimod cream or placebo at the skin with atopic dermatitis for 8 weeks. Participants who had completed the 8-week clinical trial and were well tolerant to the drug were followed up in one-arm, long-term intermittent administration (up to 52 weeks period). In the long-term medication phase, at each visit point: ① When IGA ≥ 2, Benvitimod cream was continued to be used, twice daily. ② When IGA \< 2, the drug was stopped. In the long-term follow-up, the interval of visits was 4 weeks during the medication phase and 8 weeks during the discontinuation phase.

The primary objective is to evaluate the efficacy and safety of Benvitimod cream in the treatment of mild to moderate atopic dermatitis. The primary endpoint is the proportion of participants with Investigator Global Assessment (IGA) of 0 (complete removal) or 1 (nearly complete removal) and a decrease of ≥2 points score from baseline to week 8. The study is anticipated to last from April 2022 to August 2023 with 240 participants recruited form about 20 centers in China.

All the related investigative organization and individuals will obey the Declaration of Helsinki and Chinese Good Clinical Practice standard. The study has been approved by Institutional Review Board (IRB) and Ethics Committee (EC) in Peking University People's Hospital.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Diagnosis of atopic dermatitis，course of disease ≥ 6 months，EASI ≤ 21 and 3% ≤ BSA ≤ 20%.
* IGA ≥ 3.
* Capable of giving written informed consent.

Exclusion Criteria:

* Skin lesions were limited to head, neck, hands and feet.
* ALT/AST ≥ 3 ULN、BUN/Cr ﹥ 1.5 ULN.
* Subjects with obvious cardiovascular, respiratory, gastrointestinal, liver, kidney, blood, neurological and psychological diseases that are unstable or not well controlled.
* Subjects have any systemic disease or other active skin disease that may affect the evaluation of the study results, or have scar, freckle, tattoo, etc. in the affected area that may affect the evaluation of skin lesions.
* Subjects with malignant neoplasms.
* Subjects with severe comorbid conditions may require systematic hormone therapy or other interventions, affect study participation or require frequent active monitoring (e.g., unstable chronic asthma).
* Subjects with definite skin infection with local bacteria, viruses and fungi.
* Subjects with mental illness or other reasons may interfere with participation in the study.
* Known to be allergic to any of the components of the drug.
* Severe hypersensitivity to food, drugs, insect venom, rubber, etc.
* Women who are pregnant, breast-feeding, or planning to become pregnant.
* Alcohol, drug abuse and known drug dependence.
* Prior to enrollment, the following treatments were used within the specified time period:

  1. External medication used within 2 weeks (e.g. glucocorticoids, calcineurin inhibitors, tacrolimus, PDE-4 inhibitors, etc.)
  2. Systemic immunotherapy used within 4 weeks (e.g., glucocorticoids, methotrexate, JAK inhibitors, cyclosporine, etc.).
  3. Received biologics for atopic dermatitis (e.g., IL-4 inhibitors, IL-13 inhibitors, etc.) within 4 weeks (or 5 half-life, whichever is longer).
  4. Received uv therapy and photochemotherapy within 4 weeks.
* Participated in clinical trials of other drugs or medical devices within 4 weeks.
* The patients who were considered unsuitable to participate in the study by the investigators.

Primary outcomes:
measure: Proportion of participants with Investigator Global Assessment (IGA) of 0 (complete removal) or 1 (nearly complete removal) and a decrease of ≥2 points score from Baseline to Week 8
timeFrame: Week 8
Secondary outcomes:
measure: Percentage decline in Eczema Area and Severity Index (EASI) score from Baseline to Week 8
timeFrame: Week 8
measure: Proportion of participants with ≥75% improvement in Eczema Area and Severity Index (EASI) score from Baseline to Week 8
timeFrame: Week 8
measure: Proportion of participants with ≥90% improvement in Eczema Area and Severity Index (EASI) score from Baseline to Week 8
timeFrame: Week 8
measure: Proportion of participants with ≥50% improvement in Eczema Area and Severity Index (EASI) score from Baseline to Week 8
timeFrame: Week 8
measure: Proportion of participants with ≥3 score improvement in Pruritus Visual Analogue Scale (VAS) from Baseline to Week 8
timeFrame: Week 8
measure: Overall EASI improvement rate and its changes with time from Baseline to Week 8
timeFrame: Week 8
measure: The average IGA decrease and its changes with time from Baseline to Week 8
timeFrame: Week 8
measure: The average DLQI decrease and its changes with time from Baseline to Week 8
timeFrame: Week 8
measure: The average BSA decrease and its changes with time from Baseline to Week 8
timeFrame: Week 8
measure: The average Pruritus Visual Analogue Scale (VAS) decrease and its changes with time from Baseline to Week 8
timeFrame: Week 8
measure: Proportion of participants with recurrence and the time of first recurrence of 1.0% Benvitimod cream
timeFrame: Week 52
measure: Proportion of participants of IGA = 0 or 1 was achieved after retreatment 8 weeks in recurrence subjects
timeFrame: Week 52
measure: Incidence of TEAE and SAE
timeFrame: Week 52
measure: Number of recurrences in recurrence participants
timeFrame: Week 52
measure: Proportion of participants with ≥50% improvement in Eczema Area and Severity Index (EASI) score after retreatment 8 weeks in recurrence subjects
timeFrame: Week 52
measure: EASI score and IGA score decreased after retreatment 8 weeks in recurrence participants
timeFrame: Week 52
measure: Incidence of AE/ADR at each visit during medication
timeFrame: Week 52
measure: Incidence of SAE and TEAE leading to discontinuation
timeFrame: Week 52
measure: Incidence of clinical abnormalities such as laboratory tests and electrocardiogram (ECG)
timeFrame: Week 52
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
References: