Efficacy and Safety of Roflumilast Cream 0.3% in Subjects With Plaque Psoriasis: a Phase 3 Study

NCT06648772 | Completed Phase 3 FDA Drug

• 1 other identifier: HDM3014-301
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 31

Brief Summary

This study is a multi-center, randomized, double-blind, vehicle-controlled phase III study to evaluate the efficacy, safety, and PK profile of roflumilast cream 0.3% in Chinese subjects ≥6 years of age with plaque psoriasis.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects achieving IGA treatment success after 8 weeks of treatment

  The IGA is a static evaluation of qualitative overall psoriasis severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4). Each grade is defined by a distinct and clinically relevant morphologic description that minimizes inter-observer variability. Treatment success is defined as an IGA score of 0 or 1 with an improvement of ≥ 2 points from baseline.

  Baseline, week 8

Secondary Outcomes (11)

• Proportion of subjects achieving PASI-75 after 8 weeks of treatment.

  Baseline, Week 8

• Proportion of subjects achieving PASI-90 after 8 weeks of treatment.

  Baseline, Week 8

• Time required to achieve PASI-50 from baseline.

  Until week 8

• Proportion of subjects achieving IGA treatment success after 4 weeks of treatment.

  Baseline, Week 4

• Proportion of subjects with an I-IGA score ≥ 2 points at baseline achieving an I-IGA score of 0 or 1 and an improvement of ≥ 2 points from baseline after 8 weeks of treatment

  Baseline, Week 8

Study Arms (2)

Roflumilast Cream 0.3%

EXPERIMENTAL

For topical use, Q.D.

Drug: Roflumilast Cream 0.3%

Vehicle cream

PLACEBO COMPARATOR

For topical use, Q.D.

Drug: Vehicle cream

Interventions

Roflumilast Cream 0.3% DRUG

Roflumilast Cream 0.3%

Also known as: Zoryve

Roflumilast Cream 0.3%

Vehicle cream DRUG

Vehicle cream

Vehicle cream

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Fully understand the objectives and requirements of this study, voluntarily participate in the clinical trial and sign the informed consent form (ICF), and be able to complete all visits as required by the protocol.
• Aged ≥ 6 years at the time of signing the ICF, male or female.
• Clinical diagnosis of plaque psoriasis before the first dose in this study, with a disease duration of ≥ 6 months (for those aged ≥ 12 years) or ≥ 3 months (for those aged 6-11 years) and stable for the last 4 weeks.
• Patients are required to meet the following requirements at screening and baseline:
• Psoriasis involving 2%-20% BSA (excluding the scalp, palms, and soles);
• IGA score of ≥ 2 points;
• PASI score of ≥ 2 points (excluding the scalp, palms, and soles).
• Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline. FOCBP must agree to take at least one reliable form of birth control, including oral/implantable/injectable/transdermal contraceptive, intrauterine device, bilateral tubal ligation/occlusion, partner's vasectomy, and barrier contraception (used correctly throughout sexual intercourse), from 4 weeks before the first dose of the IMP until 2 months after the last dose. If the subject is routinely abstinent, the subject may use this form of contraception, but should choose a reliable form of contraception as mentioned above if the subject is no longer abstinent. Male subjects will be required to have no plans to have children, no plans to donate sperm, and agree to use highly effective contraception. from the first dose of the investigational medicinal product until 4 months after the last dose.
• Note: FOCBP are defined as female subjects who have experienced menarche, have not reached a postmenopausal state (amenorrhea for at least 12 consecutive months, with no clear cause other than menopause and confirmd by FSH), and have no surgical (i.e., bilateral oophorectomy and/or bilateral salpingectomy and/or hysterectomy) or investigator-determined causes of permanent infertility (e.g., mullerian agenesis, etc.).
• Subjects were assessed by the investigator to be free of other medical conditions that would interfere with the assessment of safety and efficacy based on medical history, physical examination, routine blood, blood biochemistry, urine, and other laboratory tests.

You may not qualify if:

• Non-plaque psoriasis (e.g., guttate psoriasis, pustular psoriasis, erythrodermic psoriasis, and arthropathic psoriasis) or drug-induced psoriasis.
• Skin disorders or other conditions that, in the judgment of the investigator, may interfere with the assessment of endpoints relevant to this study, including but not limited to: viral lesions, fungal and bacterial skin infections, parasitic infections, syphilis or tuberculosis-related skin manifestations, etc.
• Prior use of etanercept within 4 weeks before the first dose of this study, or use of adalimumab and/or infliximab within 8 weeks before the first dose of this study, or prior use of another biologic within 12 weeks before the first dose of this study (or within 5 half-lives of the biologic at the time of the first dose of this study, whichever is longer).
• Prior use of systemic drugs for psoriasis treatment or any other agents which may impact efficacy assessment of psoriasis, including but not limited to oral or intravenous glucocorticoids, retinoic acids, methotrexate, cyclosporine, and other systemic immunosuppressive agents or a class of drugs (including Chinese herbal formulas, herbs, proprietary Chinese medicines, etc.) containing Chinese medicinal ingredients within 4 weeks of the first dose of this study.
• Prior use of topical agents for psoriasis treatment or any other agents which may impact efficacy assessment of psoriasis, including but not limited to topical glucocorticoids, vitamin D analogues, benvitimod and prescription emollients or emollients containing additives (e.g., ceramides, hyaluronic acid, urea, or filamentous proteolytic products) or antipruritic ingredients (e.g., menthol, polyhydroxyethanol, pramoxine, lidocaine, prilocaine, capsaicin, naltrexone, N-palmitoylethanolamine, etc.) or a class of drugs (including Chinese herbal formulas, herbs, proprietary Chinese medicines, etc.) containing Chinese medicinal ingredients for topical use (Note: for the treatment of diseases other than psoriasis, except in cases where the use of such medicines is deemed necessary in the medical judgment of the investigator and/or the specialist and would not interfere with the assessment of the study), etc. within 2 weeks.
• Prior use of psoralen plus ultraviolet A (PUVA) or ultraviolet B (UVB) phototherapy within 4 weeks before the first dose of this study.
• Prior use of ZORYVE® cream or foam; prior use of oral roflumilast or other phosphodiesterase-4 (PDE4) inhibitors (apremilast, etc.) within 4 weeks prior to the first dose of this study.
• Prior use of antihistamines, potent cytochrome P (CYP) 450 enzyme inhibitors (such as indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir and telithromycin) or inducers (such as efavirenz, barbiturates, phenytoin sodium, and rifampicin) within 2 weeks before the first dose of this study or these drugs cannot be discontinued during the study.
• Prior use of lithium-containing agents or antimalarials within 4 weeks (or 5 half-lives, whichever is longer) prior to the first dose of this study..
• Subjects who are expected to have excessive exposure to natural/artificial light, sunbeds, or other light-emitting diode (LED) irradiation at the treatment area during the treatment period of this study.
• Planned initiation or change in the use of an existing medication (e.g., beta-blockers or angiotensin-converting enzyme inhibitors) that, in the opinion of the investigator, can affect the efficacy evaluation for psoriasis.
• Known hypersensitivity to roflumilast or any of the excipients of the product (white vaseline, isopropyl palmitate, hydroxybenzyl ester, propyl hydroxybenzoate, diethyleneglycol monoethyl ether, hexanediol, hydrochloric acid dilute, sodium hydroxide, Crodafos CES \[including cetearyl alcohol, cetyl phosphate, and ceteareth-10 phosphate\]).
• Previous or suspected human immunodeficiency virus (HIV) infection, or HIV antibody-positive at screening; or hepatitis B (hepatitis B virus surface antigen \[HBsAg\])-positive or HBsAg-negative but hepatitis B virus core antibody (HBcAb)-positive, in which case DNA quantitation should be detected and the result is higher than the upper limit of normal; or hepatitis C (hepatitis C virus \[HCV\]) antibody-positive with HCV-RNA quantification above the upper limit of normal value; or syphilis screening-positive (except for patients with a positive specific antibody test, a negative non-specific antibody test, and confirmed as inactive infection in combination with clinical judgment).
• As judged by the investigator, with known or suspected:
• Moderate to severe hepatic impairment (Child-Pugh B/C) at screening. See Appendix 16.7 for Child-Pugh grading criteria

Sponsors & Collaborators

• Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.: lead

Study Sites (31)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Location

People's Hospital of Peking University

Beijing, 100032, China

Location

Beijing Children's Hospital, Capital Medical University

Beijing, China

Location

Beijing Tongren Hospital, Capital Medical University

Beijing, China

Location

Children's Hospital of Hunan Province

Changsha, China

Location

The Second Xiangya Hospital of Central South University

Changsha, China

Location

Affiliated Hospital of Chengde Medical College

Chengde, China

Location

Sichuan Provincial People's Hospital

Chengdu, China

Location

The Second People's Hospital of Chengdu

Chengdu, China

Location

Affiliated Hospital of Chongqing Three Gorges Medical College

Chongqing, China

Location

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, China

Location

The Sixth People's Hospital of Dongguan

Dongguan, China

Location

Enshi Tujia and Miao Autonomous Prefecture Central Hospital

Enshi, China

Location

Dermatology Hospital of Southern Medical University

Guangzhou, China

Location

Hainan Fifth People's Hospital

Haikou, China

Location

The First People's Hospital of Hangzhou

Hangzhou, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, China

Location

The Second Affiliated Hospital of Harbin Medical University

Harbin, China

Location

Ji'nan Central Hospital

Ji'nan, China

Location

The First Hospital of Jilin University

Jilin City, China

Location

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Jinhua, China

Location

The Second Affiliated Hospital of Henan University of Science and Technology

Luoyang, China

Location

Affiliated Hospital of Nantong University

Nantong, China

Location

Sanmenxia Central Hospital

Sanmenxia, China

Location

Shanghai Skin Disease Hospital

Shanghai, China

Location

The Second Affiliated Hospital of South Anhui Medical College

Wuhu, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Location

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Location

The First People's Hospital of Yancheng

Yancheng, China

Location

Zhengzhou Central Hospital

Zhengzhou, China

Location

Affiliated Hospital of Jiangsu University

Zhenjiang, China

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 18, 2024
• Study Start: November 14, 2024
• Primary Completion: October 13, 2025
• Study Completion: October 15, 2025
• Last Updated: July 6, 2026

Record last verified: 2025-10

Locations

CN (31)