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Efficacy and Safety Study of Hemay005 in Subjects With Moderate to Severe Plaque Psoriasis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Efficacy and Safety Study of Hemay005 in Subjects With Moderate to Severe Plaque Psoriasis

A Phase Ⅱ Efficacy and Safety Study of Hemay005 in Subjects With Moderate to Severe Plaque Psoriasis

NCT04102241•Tianjin Hemay Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

Summary

Hemay005 is a novel phosphodiesterase type 4(PDE4) inhibitor being developed for the treatment of psoriasis.After single asending dose and mutiple asending dose in health subjects. And the patients with moderate to severe plaque psoriasis will be randomized into 4 cohorts(15mg, 30mg, 60mg and placebo) approximately 216 subjects will be enrolled (52 for each cohort ). This study includes an 16-week treatment Period, then a 36-week Treatment Period without placebo.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female at least 18 years of age and less than or equal to 75;
•Diagnosed with plaque psoriasis more than 6 months;
•Screening and baseline PSAI ≥12, sPGA≥3（Moderate to Severe）,affected body surface area BSA≥10%;
•Investigator determined suitable for systemic treatment of psoriasis;
•All subjects must agree and commit to the use of a reliable contraceptive regimen. Women of childbearing potential must undergo monthly pregnancy testing during the study and agree to use two of the following methods of contraception throughout the study and for 90 days after the last dose of study drug. Reliable contraceptive regimen: vasectomy, abstinence, the use of condoms, intrauterine contraceptives (IUD), (Oral administration, patch, ring, injection, implantation) Barrier methods (diaphragm with spermicide, condom with spermicide);
•Ability to understand and be willing to sign a written informed consent before study entry.

Exclusion Criteria

•Forms of psoriasis other than chronic plaque-type; (i.e., erythrodermic and guttate psoriasis, palmar, plantar or nail disease) at screening, Investigator diagnosed with drug-induced psoriasis (i.e., from beta-blockers, calcium channel inhibitors or lithium) prior to randomization;
•A history of chronic infection (i.e., tuberculosis);
•A condition of any skin disease(i.e., dermatitis) ;
•History of systemic autoimmune inflammatory disease that effect drug evaluation;
•Patients with an active infection who are assessed by the investigator as at increased risk;
•TB infection, high risk of acquiring TB infection, latent TB infection (LTBI), or current or history of NTMB infection;
•Subjects who used any of the following treatments : 2 weeks before randomize (including but not limited to local use of Glucocorticoids, topical retinoic acid preparations, vitamin D derivatives, tacrolimus, pimeklimus, dianthranol, etc) Except for the following situations: In the face, armpit and groin psoriasis skin lesions using weak or inefficient local use of glucocorticoid (efficacy grade 6-7) or scalp psoriasis skin lesions with coal tar shampoo, salicylic acid topical preparations, selenium disulfide, the use of non-pharmaceutical emollients (such as silicone cream, vitamin E cream, etc.) ; 4 weeks before randomize , Non-biological drug systemic therapy (including but not limited to systemic glucocorticoid, leflunomide, cyclophosphamide, methotrexate, cyclosporine, retinoic acid, traditional Chinese medicine decoction, proprietary Chinese medicine for the treatment of psoriasis, etc.), 2 weeks before randomize with UVB treatment, 4 weeks before randomize with psoralen and long wave ultraviolet (PUVA) therapy, 12 weeks before randomize with biological agents such as adamuzumab, enasip or infliximab, 24 weeks before randomize with alefacept, Briakinumab, Ustekinumab, Secukinumab; Subjects with psoriasis worsen or rebound 4 weeks before screening;
•Subjects who congenital or acquired immunodeficiency;
•Subjects couldn't limit their uv exposure during the study period (e.g. sunbathing and/or tanning devices);
•History of apremilast ;
+11 more criteria

Locations (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Key Dates

Start Date

May 30, 2019

Primary Completion Date

October 12, 2020

Completion Date

July 21, 2021

Last Updated

October 13, 2021

Enrollment

216

ACTUAL participants

Conditions

Psoriasis

Interventions

15mg Hemay005

DRUG

Placebos

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 13, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety Study of Hemay005 in Subjects With Moderate to Severe Plaque Psoriasis

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments