AzTrials
AzTrials

Plaque PsoriasisPhase 3NCT06648772

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

A Phase 3 study testing Roflumilast Cream 0.3% in people with Plaque Psoriasis, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 31 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 6 years and older
Conditions the study is for
Plaque Psoriasis
What is being tested?
Roflumilast Cream 0.3%
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
190 participants
Where
31 sitesChina
Study dates
14 Nov 2024to 15 Oct 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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;
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
Show all 28Show fewer
  • 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
  • Total bilirubin and or AST and or ALT > 1.5 x ULN at screening
  • SCr > 1.5 x ULN at screening
  • History of major depressive disorder, suicidality, or suicidal tendency suggested by the C-SSRS at baseline or screening.
  • PHQ-8 (adults) or modified PHQ-A (aged 12-17 years) ≥ 10 points, for children aged 6-11 years, investigators assessed the presence or risk of depression after communicating with their parents/guardians at baseline or screening.
  • Female subjects in the lactating period; or subjects who have a fertility plan during the study.
  • Alcohol (defined as >2 units of alcohol per day/>14 units of alcohol per week, with 1 unit of alcohol equivalent to 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine) or drug abuse within 6 months before screening in this study.
  • Have undergone a major surgery within 4 weeks prior to the first dose of this study (for the definition of major surgery, refer to Level 3 and Level 4 surgeries specified in the "Measures for the Classification of Surgical Procedures in Medical Institutions" issued by the National Health Commission of the People's Republic of China on Dec. 6, 2022) or plan to undergo a major surgery during the study.
  • Cancer (except for non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ, stage I uterine cancer, cervical carcinoma in situ, or breast carcinoma in situ that have been treated with curative therapy) within 5 years before the first dose of this study.
  • Prior active infection requiring the use of oral or intravenous antibiotics, antifungal or antiviral agents within 7 days before the first dose of this study.
  • Any serious disease or medical measure, physical or mental condition that, in the opinion of the investigator, will affect the subject's participation in the trial (including the use of IMP and participation in required study visits), or that, in the opinion of the investigator, will pose a significant risk or effect to the subject.
  • Family members involving staff from the clinical research organization, contract research organization (CRO, if applicable), or sponsor participated in the design or conduct of this study, or a family member has already been enrolled in this study.
  • Currently participating in any other interventional clinical trials; or participation in a pharmaceutical clinical trial within 3 months or 5 half-lives (whichever is longer) or any other interventional clinical trial within 3 months prior to the first dose of this study.
  • Other reasons judged by the investigator as inappropriate for enrollment in this study.

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

China31 sites

  • People's Hospital of Peking University

    Beijing, 100032

  • Beijing Children's Hospital, Capital Medical University

    Beijing

  • Beijing Tongren Hospital, Capital Medical University

    Beijing

  • Children's Hospital of Hunan Province

    Changsha

  • The Second Xiangya Hospital of Central South University

    Changsha

  • Affiliated Hospital of Chengde Medical College

    Chengde

  • Sichuan Provincial People's Hospital

    Chengdu

  • The Second People's Hospital of Chengdu

    Chengdu

  • Affiliated Hospital of Chongqing Three Gorges Medical College

    Chongqing

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing

  • The Sixth People's Hospital of Dongguan

    Dongguan

  • Enshi Tujia and Miao Autonomous Prefecture Central Hospital

    Enshi

  • Dermatology Hospital of Southern Medical University

    Guangzhou

  • Hainan Fifth People's Hospital

    Haikou

  • The First People's Hospital of Hangzhou

    Hangzhou

  • Zhejiang Provincial People's Hospital

    Hangzhou

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin

  • Ji'nan Central Hospital

    Ji'nan

  • The First Hospital of Jilin University

    Jilin City

  • The Fourth Affiliated Hospital of Zhejiang University School of Medicine

    Jinhua

  • The Second Affiliated Hospital of Henan University of Science and Technology

    Luoyang

  • Affiliated Hospital of Nantong University

    Nantong

  • Sanmenxia Central Hospital

    Sanmenxia

  • Shanghai Skin Disease Hospital

    Shanghai

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning

  • The Second Affiliated Hospital of South Anhui Medical College

    Wuhu

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

  • The First People's Hospital of Yancheng

    Yancheng

  • Zhengzhou Central Hospital

    Zhengzhou

  • Affiliated Hospital of Jiangsu University

    Zhenjiang

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Vehicle-controlled Phase 3 Clinical Study To Evaluate The Efficacy and Safety Of Roflumilast Cream 0.3% (Zoryve®) in the Treatment of Plaque Psoriasis In China

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.

Being tested
Roflumilast Cream 0.3%, Vehicle cream

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Roflumilast Cream 0.3%Drug

    Also called Zoryve

    Roflumilast Cream 0.3%

  • Vehicle creamDrug

    Vehicle cream

Study groups in NCT06648772
Study groupRoleWhat they receive
Roflumilast Cream 0.3%ExperimentalFor topical use, Q.D.
Receives: Drug: Roflumilast Cream 0.3%
Vehicle creamPlacebo comparatorFor topical use, Q.D.
Receives: Drug: Vehicle cream

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, week 8

Secondary outcomes (11)

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

    PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). Subjects achieving PASI-75 are those who achieve a 75% reduction in PASI from baseline.

    Measured: Baseline, Week 8

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

    PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). Subjects achieving PASI-90 are those who achieve a 90% reduction in PASI from baseline.

    Measured: Baseline, Week 8

  3. Time required to achieve PASI-50 from baseline.

    Time required to achieve PASI-50 (i.e., PASI reduction ≥ 50% from baseline) from baseline.

    Measured: Until week 8

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

    Measured: Baseline, Week 4

  5. 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

    I-IGA means Intertriginous area IGA. For subjects with intertriginous area involvement of at least 'mild' severity by IGA (I-IGA≥2) at Baseline (using the IGA scale but evaluating intertriginous areas ONLY and NOT whole body involvement), an I-IGA will be recorded.

    Measured: Baseline, Week 8

  6. Proportion of subjects with an I-IGA score ≥ 2 points at baseline achieving an I-IGA score of "0" after 8 weeks of treatment

    I-IGA means Intertriginous area IGA. For subjects with intertriginous area involvement of at least 'mild' severity by IGA (I-IGA≥2) at Baseline (using the IGA scale but evaluating intertriginous areas ONLY and NOT whole body involvement), an I-IGA will be recorded.

    Measured: Baseline, Week 8

  7. Proportion of subjects with WI-NRS of ≥ 4 at baseline and a decrease in WI-NRS of ≥ 4 from baseline after 2, 4, and 8 weeks of treatment

    WI-NRS (Worst Itch Numerical Rating Scale) assessments will be performed for subjects 12 years and older. The WI-NRS will be determined by asking the subject's assessment of worst itch over the past 24 hours. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").

    Measured: Week 2, 4, 8

  8. Changes from baseline in the score of DLQI (aged ≥ 17 years)/CDLQI (aged 6-16 years) after 4 and 8 weeks of treatment

    Dermatology Life Quality Index (DLQI) and Children's Dermatology Life Quality Index (CDLQI) will be performed to measure how much skin problem has affected subjects' life over the last week.

    Measured: Week 4, 8

  9. Changes from baseline in the total score of PSD (for adult subjects only) after 4 and 8 weeks of treatment

    Psoriasis Symptom Diary (PSD) will be used to assess the improvement in psoriasis symptom.

    Measured: From baseline to Week 4 and 8

  10. treatment emergence adverse events

    Incidence, severity, and causal relationship of treatment emergence adverse events (TEAE), TEAEs leading to withdrawal and death.

    Measured: Throughout the study

  11. Trough concentration (Ctrough)

    Trough concentration of plasma roflumilast and its N-oxide

    Measured: week 2, 4, 6, 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2024
  2. Study start14 Nov 2024
  3. Primary completion13 Oct 2025
  4. Study completion15 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
190 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06648772
Sponsor's protocol ID
HDM3014-301
Status last verified
Oct 2025
First submitted
9 Oct 2024
Last updated
6 Jul 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Roflumilast Cream 0.3% in people with Plaque Psoriasis, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 31 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects achieving IGA treatment success after 8 weeks of treatment (time frame: Baseline, week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06648772.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in