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

NCT04839328 | Completed Phase 3

• 1 other identifier: HM005PS3S01
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 1

Brief 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. phase 2 results suggest Hemay005 60 mg BID has a higher curative effect trend，and adverse reactions were mild, so we choose 60 mg BID as Hemay005 phase 3 dosage And the patients with moderate to severe plaque psoriasis will be randomized into 2 cohorts(60mg BID and placebo) approximately 306 subjects will be enrolled (204 in 60mg BID and 102 in placebo). This study includes an 16-week treatment Period, then a 36-week Treatment Period without placebo.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects who have 75% or more reduction in [Psoriasis area-and-severity index score (PASI)] (PASI75).

  The proportion of subjects who have a reduction of 75% or more from baseline in the psoriasis area-and-severity index score (PASI 75) at week 16.

  week 16

Secondary Outcomes (4)

• Proportion of subjects achieving an overall sPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline.

  week 16

• Proportion of subjects who have 75% or more reduction in [Psoriasis area-and-severity index score (PASI)] (PASI75).

  1 year

• Proportion of subjects achieving an overall sPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline.

  1 year

• Proportion of subjects who have 90% or more reduction in [Psoriasis area-and-severity index score (PASI)] (PASI90).

  1 year

Study Arms (2)

60mg Hemay005

EXPERIMENTAL

Patients with chronic plaque psoriasis will be treated BID for 16 weeks with 60mg Hemay005 in first phase. Then will be treated BID for 36-week extension followed with 60mg of Hemay005.

Drug: 60mg Hemay005

Placebo

PLACEBO COMPARATOR

Patients with chronic plaque psoriasis will be treated BID for 16 weeks with placebo in first phase. Then will be treated BID for 36-week extension followed with 60mg of Hemay005.

Drug: Placebo

Interventions

60mg Hemay005 DRUG

Hemay005 is a small molecule PDE4 inhibitor.

Also known as: Hemay005 tablet

60mg Hemay005

Placebo DRUG

Placebos are the same as drugs, but contain no Hemay005.

Also known as: placebo tablet

Placebo

Eligibility Criteria

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

You may qualify if:

• At the time of signing the informed consent, the age was more than or equal to 18 years old, regardless of gender；
• Stable plaque psoriasis with a history of more than 6 months (from the time of randomization)；
• Screening and baseline PSAI ≥12, sPGA≥3（Moderate to Severe）,affected body surface area BSA≥10%；
• 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)；
• The subjects voluntarily participated in the study and signed the informed consent .

You may not qualify if:

• Forms of psoriasis other than chronic plaque-type; (i.e., erythrodermic and guttate psoriasis, palmar, plantar or nail disease) at screening;
• Investigator diagnosed as drug-induced psoriasis (including but not limited to new onset or aggravation of psoriasis caused by beta blockers, calcium channel inhibitors or lithium preparations);
• Skin diseases, chronic diarrhea, serious digestive system diseases (such as active gastric ulcer, gastrointestinal bleeding, etc.), or other autoimmune inflammatory diseases that may interfere with clinical evaluation, according to the investigator;
• The screening period was accompanied with active infection (such as bacterial infection, viral infection, fungal infection, etc., which required oral or intravenous treatment), and the investigator assessed that participation in this study may increase the risk of subjects;
• Subjects with a history of tuberculosis or active tuberculosis (there were signs or symptoms of active tuberculosis judged by the researcher at the time of screening);
• Use of prohibited treatments of this study;
• History of congenital or acquired immunodeficiency;
• Subjects couldn't limit their uv exposure during the study period ;
• History of apremilast or Hemay005 tablets;
• Subjects with conditions that may affect oral drug absorption, such as subtotal gastrectomy, clinically significant diabetic gastroenteropathy, or certain types of weight-loss surgery, such as gastric bypass surgery, do not include surgery that simply separates the stomach into separate Chambers, such as gastric banding surgery;
• Subjects with tumor or history of malignancy (solid organ tumor or hematological tumor including myelodysplastic syndrome) in the past 5 years;
• History of alcohol or drug abuse or dependence in the past year;
• Subjects with a history of mental illness, suicidal behavior (including positive attempt, interrupted attempt or attempted suicide) or suicidal thoughts in the past 6 months were not suitable for clinical trials after the evaluation of the investigator; subjects with severe anxiety or depression during the screening period were assessed as severe anxiety or depression;
• There are clinically serious, progressive or uncontrollable diseases in the screening period, including but not limited to respiratory system, cardiovascular system, endocrine system, blood system, musculoskeletal system and nervous system. According to the assessment of investigator, participating in this study may increase the risk of subjects or interfere with data interpretation;
• In the screening period, human immunodeficiency virus (HIV) serological positive (i.e., HIV antibody positive);Evidence of hepatitis B virus infection: hepatitis B surface antigen (HBsAg) positive, or hepatitis B core antibody (HBcAb) positive and HBV-DNA above the upper limit of the normal range, or hepatitis B E antibody (HBeAb) positive and HBV-DNA above the upper limit of the normal range;Evidence of hepatitis C virus (HCV) infection: HCV antibody positive;

Sponsors & Collaborators

• Tianjin Hemay Pharmaceutical Co., Ltd: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Hemay005

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• jianzhong Zhang

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 9, 2021
• Study Start: January 20, 2022
• Primary Completion: October 25, 2022
• Study Completion: July 28, 2023
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)