PsoriasisPhase 3NCT04839328

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

A Phase 3 study testing 60mg Hemay005 in people with Psoriasis, run by Tianjin Hemay Pharmaceutical Co., Ltd at 1 site in China.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Psoriasis
What is being tested?: 60mg Hemay005
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 306 participants
Where: 1 siteChina
Study dates: 20 Jan 2022to 28 Jul 2023
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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 .

Who cannot join

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;

Show all 25Show fewer

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;
During the screening period, there were any of the following laboratory abnormalities:
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times the upper limit of normal value, or total bilirubin > 1.5 times the upper limit of normal value;
Serum creatinine > 1.2 times the upper limit of normal value;
The hemoglobin of male patients was less than 8.5 g / dl (85.0 g / L), and that of female patients was less than 8.0 g / dl (80.0 g / L);
WBC count < 3.0 × 109 / L or ≥ 14 × 109 / L;
Platelet count < 100 × 109 / L
Female who were pregnant during lactation or pregnancy, or during the planned study period, or subjects who had sperm / egg donation plans during the study period;
Know allergic to active ingredient or excipient of the investigational product;
Participated in any other interventional clinical trial within 4 weeks or 5 pharmacokinetic / pharmacodynamic half lives before randomization (whichever is longer);
The investigator considered that there are any other conditions that are not suitable for participating in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

Peking University People's Hospital
Beijing, Beijing Municipality, 100044

Other trials in China

About this study

Official title: A Phase Ⅲ Multicenter, Randomized, Double-blind, Placebo-controlled To Assess Efficacy and Safety Study of Hemay005 in Subjects With Moderate to Severe Plaque Psoriasis

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.

Read the detailed description

Primary Objectives:

To evaluate the effectiveness of Hemay005 tablets 60 mg twice daily (BID) compared with placebo in patients with moderate to severe chronic plaque psoriasis.

Secondary objective：

Evaluate other efficacy characteristics of Hemay005 tablets 60 mg BID compared with placebo in patients with moderate to severe chronic plaque psoriasis.
Evaluate the safety of Hemay005 tablets 60 mg BID in patients with moderate to severe chronic plaque psoriasis.
To evaluate the population pharmacokinetics (PPK) characteristics of Hemay005 tablets 60 mg BID in patients with moderate to severe chronic plaque psoriasis.

Conditions: Psoriasis
Being tested: 60mg Hemay005, Placebo
Medical subject headings: Psoriasis

What participants receive

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

60mg Hemay005Drug
Also called Hemay005 tablet
Hemay005 is a small molecule PDE4 inhibitor.
PlaceboDrug
Also called placebo tablet
Placebos are the same as drugs, but contain no Hemay005.

Study groups in NCT04839328
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Placebo

What is being measured

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

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.
Measured: 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.
The static Physician's Global Assessment (sPGA) rated the investigator's overall clinical assessment of a participants plaque thickness, erythema, and scaling on a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (majority of plaques have severe thickness, erythema, and scale). To assign a sPGA score, the investigator examined all psoriatic lesions and assigned a severity score ranging from 0 to 5 for thickness, erythema, and scaling. Scores for thickness, erythema, and scaling are summed and the mean of these 3 scores equals the overall sPGA score. Decreases in sPGA correspond to clinical improvement.
Measured: week 16
Proportion of subjects who have 75% or more reduction in [Psoriasis area-and-severity index score (PASI)] (PASI75).
PASI-75 was defined as a ≥75% decrease in the PASI at visit from the baseline PASI and was calculated as: ([baseline PASI - visit PASI]/ baseline PASI) ×100%.
Measured: 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.
The SPGA score can determine the overall damage of psoriasis at a given time point，and higher SPGA scores mean a worse outcome.
Measured: 1 year
Proportion of subjects who have 90% or more reduction in [Psoriasis area-and-severity index score (PASI)] (PASI90).
The PASI-90 was defined as a ≥90% decrease from baseline in the PASI score at the visit，and higher PASI scores mean a worse outcome.
Measured: 1 year

Timeline

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

20 Jan 202228 Jul 2023

First posted9 Apr 2021
Study start20 Jan 2022
Primary completion25 Oct 2022
Study completion28 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PsoriasisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Single blind
Who is masked: Participant
Enrolment: 306 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04839328
Sponsor's protocol ID: HM005PS3S01
Status last verified: Jan 2024
First submitted: 1 Apr 2021
Last updated: 16 Jan 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ⅲ Multicenter, Randomized, Double-blind, Placebo-controlled To Assess Efficacy and Safety Study of Hemay005 in Subjects With Moderate to Severe Plaque Psoriasis
ClinicalTrials.gov ID: NCT04839328
Acronym / sponsor ID: HM005PS3S01
Conditions: Psoriasis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 306 participants (actual)
Lead sponsor: Tianjin Hemay Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
Study start: 20 Jan 2022 (actual)
Primary completion: 25 Oct 2022 (actual)
Study completion: 28 Jul 2023 (actual)
First posted: 9 Apr 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Primary Objectives:

To evaluate the effectiveness of Hemay005 tablets 60 mg twice daily (BID) compared with placebo in patients with moderate to severe chronic plaque psoriasis.

Secondary objective：

Evaluate other efficacy characteristics of Hemay005 tablets 60 mg BID compared with placebo in patients with moderate to severe chronic plaque psoriasis.
Evaluate the safety of Hemay005 tablets 60 mg BID in patients with moderate to severe chronic plaque psoriasis.
To evaluate the population pharmacokinetics (PPK) characteristics of Hemay005 tablets 60 mg BID in patients with moderate to severe chronic plaque psoriasis.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
60mg Hemay005	Experimental	Drug: 60mg Hemay005Patients 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.
Placebo	Placebo comparator	Drug: PlaceboPatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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 .

Key exclusion criteria (25 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
60mg Hemay005Also: Hemay005 tabletHemay005 is a small molecule PDE4 inhibitor.	Drug	60mg Hemay005
PlaceboAlso: placebo tabletPlacebos are the same as drugs, but contain no Hemay005.	Drug	Placebo

Primary outcome

Proportion of subjects who have 75% or more reduction in [Psoriasis area-and-severity index score (PASI)] (PASI75).
Time frame: week 16
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.

4 secondary outcomes

Proportion of subjects achieving an overall sPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline.
Time frame: week 16
Proportion of subjects who have 75% or more reduction in [Psoriasis area-and-severity index score (PASI)] (PASI75).
Time frame: 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.
Time frame: 1 year
Proportion of subjects who have 90% or more reduction in [Psoriasis area-and-severity index score (PASI)] (PASI90).
Time frame: 1 year

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
Individual participant dataSharing planned: No

Related trials for Psoriasis

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

jianzhong Zhang principal investigator

Peking University People's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 60mg Hemay005 in people with Psoriasis, run by Tianjin Hemay Pharmaceutical Co., Ltd at 1 site 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 5 inclusion and 25 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 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 who have 75% or more reduction in [Psoriasis area-and-severity index score (PASI)] (PASI75). (time frame: week 16). 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 NCT04839328.

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 16 Jan 2024.