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PsoriasisPhase 2NCT04102241

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

A Phase 2 study testing 15mg 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

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Psoriasis
What is being tested?
15mg Hemay005
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
216 participants
Where
1 siteChina
Study dates
30 May 2019to 21 Jul 2021
Phase
Phase 2
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

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 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;
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  • 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 ;
  • 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;
  • sCr≥1.5 upper limit of normal (ULN); AST≥2ULN; ALT≥2 ULN
  • WBC<3.0×109/L or WBC>14×109/L,PLT<100×109/L, Hb<85 g/L;
  • Subjects with a malignant tumor, or any history of malignancy within 5 years (except skin squamous cell carcinoma in situ, basal cell carcinoma or cervical carcinoma in situ that has been treated and has no evidence of recurrence in the past 12 weeks);
  • Subjects with positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody at screening;
  • Has a history of alcohol or drug abuse or dependence, or a history of mental illness;
  • Has committed suicide (Includes active attempts, discontinued attempts or attempted attempts) or suicidal thoughts within the past 6 months;
  • Pregnant or lactating women or planning pregnancy during the study period;
  • Know allergic to active ingredient or excipient of the investigational product;
  • 4 weeks before randomize, participated in a clinical trial and use of the study drug;
  • Accompanied by severe, progressive, or uncontrolled disease or in the investigator's opinion unsuitable to be enrolled.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310009

Other trials in China

About this study

Official title: A Phase Ⅱ 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. 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.

Conditions
Psoriasis
Being tested
15mg Hemay005, Placebos
Keywords
psoriasis, PDE4
Medical subject headings
Psoriasis

What participants receive

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

  • 15mg Hemay005Drug

    Also called No other intervention name.

    Hemay005 is a small molecule PDE4 inhibitor.

  • PlacebosDrug

    Also called No other intervention name.

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

Study groups in NCT04102241
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPatients 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 30mg of Hemay005.
Receives: Drug: Placebos
15mg Hemay005ExperimentalPatients with chronic plaque psoriasis will be treated BID for 16 weeks with 15mg Hemay005 in first phase. Then will be treated BID for 36-week extension followed with 15mg of Hemay005.
Receives: Drug: 15mg Hemay005; Drug: Placebos
30mg Hemay005ExperimentalPatients with chronic plaque psoriasis will be treated BID for 16 weeks with 30mg Hemay005 in first phase. Then will be treated BID for 36-week extension followed with 30mg of Hemay005.
Receives: Drug: 15mg Hemay005; Drug: Placebos
60mg Hemay005ExperimentalPatients 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: 15mg Hemay005

What is being measured

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

  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.

    Measured: week16

Secondary outcomes (3)

  1. Severity of Adverse Events and Serious Adverse Events.

    Severity of all Adverse Events (AEs) and Serious Adverse Events (SAEs) that occur during the whole trial including the observational period (AEs and SAEs include but not limited to comorbidities, such as hypertension, diabetes, and cardiovascular diseases).

    Measured: week2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56.

  2. Cmax of Hemay005.

    Maximum observed serum concentration.

    Measured: week8

  3. 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: week2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56.

Timeline

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

  1. First posted25 Sep 2019
  2. Study start30 May 2019
  3. Primary completion12 Oct 2020
  4. Study completion21 Jul 2021

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
216 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04102241
Sponsor's protocol ID
HM005PS2S01
Status last verified
Oct 2021
First submitted
20 Mar 2019
Last updated
13 Oct 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 15mg 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 6 inclusion and 21 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 13 Oct 2021. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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: week16). 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 NCT04102241.

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 13 Oct 2021.

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