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Effects, Drug SidePhase 2NCT05858047

An Investigational Study to Evaluate Experimental Medication SYHX1901 Tablets With Moderate to Severe Plaque Psoriasis

A Phase 2 study testing SYHX1901 in people with Effects, Drug Side, run by CSPC Ouyi 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

The purpose of this study is to evaluate the efficacy and safety of different doses of SYHX1901 tablets in the treatment of moderate to severe plaque psoriasis in order to select doses for further clinical trials. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Effects, Drug Side
What is being tested?
SYHX1901
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
93 participants
Where
1 siteChina
Study dates
11 Apr 2023to 21 Feb 2024
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

  • Subjects fully understand and voluntarily participate in this study and sign informed consent;
  • Age ≥18 and ≤ 75 years old;
  • Subjects with a clinical diagnosis of stable moderate-to-severe plaque psoriasis with a history ≥6 months before randomization; Subjects with stable moderate-to-severe plaque psoriasis defined as meeting all four of the following criteria simultaneously:
  • Subject must be diagnosed of chronic plaque psoriasis with no morphological changes or significant outbreaks of disease activity assessed by the investigator;
  • Subject must be a candidate for systemic treatment or phototherapy assessed by the investigator;
  • Body Surface Area (BSA) affected by plaque-type psoriasis ≥10% at screening and baseline;
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  • PASI score of ≥12 and Physician's Global Assessment (PGA) score ≥3 at screening and baseline;
  • Negative blood pregnancy results should be provided 14 days (inclusive) and 3 days (inclusive) prior to initial dosing, and subjects and their partners should voluntarily take contraceptive measures considered effective by the investigator during the study period and for at least 28 days after the study;
  • Subjects must be volunteer and be able to complete study procedures and follow-up examinations.

Who cannot join

  • Forms of psoriasis other than plaque psoriasis (Guttate psoriasis、erythrodermic psoriasis、Pustular psoriasis、Drug-induced psoriasis);
  • Previous or current autoimmune disease;
  • Other active skin conditions that may affect the clinical evaluation of psoriasis;
  • Active infection or fever at randomization;
  • Severe bacterial, fungal, or viral infection requiring hospitalization/intravenous drug treatment within 60 days prior to randomization;
  • Any proven history of untreated bacterial infection within 60 days prior to randomization;
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  • Any existing evidence of chronic infection;
  • Any proven history of infection of a joint prosthesis or receiving antibiotics for a suspected joint prosthesis infection;
  • Received live vaccine within 60 days before randomization or scheduled to receive live vaccine within 60 days after the end of the study;
  • History of severe herpes zoster or sever herpes simplex infection;
  • Abnormal hepatitis B virus (HBV) related check during screening;
  • Hepatitis C virus (HCV) antibody positive at screening;
  • HIV antibody or treponema pallidum antibody positive;
  • Any known or suspected condition of congenital or acquired immunodeficiency;
  • Tuberculosis (TB);
  • Symptoms or signs of progressive or uncontrolled kidney, liver, blood, gastrointestinal, endocrine, lung, heart, neurological, psychiatric, or brain disease, or with other chronic diseases that the investigator has determined are not suitable for participation in this clinical trial;
  • History of malignancy or lymphoproliferative disease within 5 years (except for cured basal cell carcinoma and in situ cervical cancer);
  • Major surgery within 8 weeks before randomization or surgery planned during the study;
  • Uncontrolled hypertension, systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg after systemic treatment;
  • Having unstable cardiovascular disease defined as presence of a clinical cardiovascular event in the last 3 months or hospitalized for heart disease within the last 3 months; or NYHA≥3 grade, or abnormal ECG suggesting clinically significant and assessed by the investigator as carrying unforeseen risks;
  • History of arterial or venous thrombosis or at high risk;
  • Significant gastrointestinal disorders, such as erosion, hemorrhagic gastroenteritis, a history of bleeding from gastrointestinal ulcers, inflammatory bowel disease, and other disorders that investigator consider to be at risk for gastrointestinal perforation or that may interfere with drug ingestion, transport, or absorption;
  • Uncontrolled hyperlipidemia (TG>2.3 mmol/L and/or LDL>3.4 mmol/L) after standard treatment;
  • Low body weight (weight ≤45 kg or BMI≤18 kg/m^2);
  • BMI ≥30kg/m^2， (severe obesity);
  • Have received local anti-psoriasis therapy within 2 weeks prior to randomization; If topical moisturizers have been used within 2 weeks, they should be continued throughout the trial, with the same frequency and dose until the end of the study;
  • Have used physical therapy within 4 weeks prior to randomization (including photochemotherapy, ultraviolet therapy);
  • Systemic treatments:
  • Systemic anti-psoriasis therapy within 4 weeks before study drug initiation;
  • Leflunomide within 6 months before study drug initiation;
  • Opioid analgesics within 4 weeks before study drug initiation;
  • Lithium and antimalarial drugs within 4 weeks before study drug initiation;
  • Any CYP3A4 potent inhibitor/inducer within 4 weeks before study drug initiation;
  • Any P-gp potent inhibitor/inducer within 4 weeks before study drug initiation;
  • Thymosin administered by injection or orally within 4 weeks before study drug initiation;
  • Use of BCRP-sensitive substrate drugs assessed by the investigator during the study;
  • Biological agents:
  • Exposure to any biological drug directly targeting IL-17 or IL-12, or IL-23 within 6 months prior to randomization ;
  • Exposure to any TNF monoclonal antibody within 2 months prior to randomization;
  • Exposure to any monoclonal antibodies against CD20 within 6 months prior to randomization;
  • Exposure to any T cell or B cell modulators or integrin pathway modulators within 3 months prior to randomization;
  • Any other biological drugs within 5 half-lives before study drug initiation;
  • Enrolled in a clinical study of any other drug within 3 months or use of any other investigational drugs within 5 half-lives of the investigational treatment before randomization;
  • History of lack of response to treatment after at least 3 months of treatment with any monoclonal antibody targeting IL-17 or IL-23 at approved doses;
  • Organ transplantation (except corneal transplantation more than 3 months before the initiation of the investigational drug);
  • Impossible to avoid prolonged daylight exposure during the trial, or to plan to use UV health rooms or other UV light sources;
  • Laboratory abnormalities of clinical significance assessed by the investigator to pose a risk:
  • AST or ALT ≥ 2×ULN;
  • Total bilirubin and/or direct bilirubin >2×ULN;
  • Neutrophil absolute value (NEUT#) <1.5×10^9/L;
  • Electrolyte imbalance;
  • History of alcohol and drug abuse or test positive for drug abuse;
  • History of neurological or psychiatric disorders, such as depression, suicidal tendencies, epilepsy, dementia, etc;
  • Any other medical and/or social reasons identified by the investigator as inappropriate for participation in the study;
  • Members of the research team and their immediate families.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Huashan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase Ⅱ Study to Evaluate the Efficacy and Safety of SYHX1901 Tablets in the Treatment of Moderate to Severe Plaque Psoriasis

The purpose of this study is to evaluate the efficacy and safety of different doses of SYHX1901 tablets in the treatment of moderate to severe plaque psoriasis in order to select doses for further clinical trials.

Read the detailed description

This is a multicenter, randomized, double-blind, placebo-controlled phase Ⅱ study to evaluate the efficacy and safety of three different doses of SYHX1901 tablets compared with placebo in the treatment of moderate to severe plaque psoriasis. The total duration of the study will be 20 weeks which will be comprised of: a screening period (4 weeks); an efficacy assessment period (12 weeks) and a follow-up assessment period (4 weeks). Eligible subjects will be randomly assigned to SYHX1901 60 mg qd, 90 mg qd, 180 mg qd or placebo group at a 1:1:1:1 ratio for continuous oral administration for 12 weeks. The presence or absence of treatment with biological agents will be a stratification factor. Subjects will be monitored for the safety throughout the study.

Being tested
Placebo, SYHX1901
Medical subject headings
Drug-Related Side Effects and Adverse Reactions

What participants receive

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

  • PlaceboDrug

    Administered orally, once daily (QD)

  • SYHX1901Drug

    Administered orally, once daily (QD)

Study groups in NCT05858047
Study groupRoleWhat they receive
Group I (Placebo)Placebo comparatorPlacebo will be administered orally (PO) for 12 weeks.
Receives: Drug: Placebo
Group Ⅱ (SYHX1901 60 mg)ExperimentalSYHX1901 will be administered orally (PO) for 12 weeks.
Receives: Drug: SYHX1901
Group III (SYHX1901 90 mg)ExperimentalSYHX1901 will be administered orally (PO) for 12 weeks.
Receives: Drug: SYHX1901
Group Ⅳ (SYHX1901 180 mg)ExperimentalSYHX1901 will be administered orally (PO) for 12 weeks.
Receives: Drug: SYHX1901

What is being measured

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

  1. Percentage of Participants Achieving a Psoriasis Area and Severity Index Score ≥75% (PASI 75) response

    Measured: Week 12

Secondary outcomes (4)

  1. Percentage of Participants Achieving a Psoriasis Area and Severity Index Score ≥50% (PASI 50) response

    Measured: Week 12

  2. Percentage of Participants Achieving a Physician Global Assessment (PGA) of 0 or 1

    Measured: Week 12

  3. Change from Baseline in Body Surface Area (BSA) affected with Psoriasis to Week 12

    Measured: Week 12

  4. Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) of 0 or 1

    Measured: Week 12

Timeline

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

  1. First posted15 May 2023
  2. Study start11 Apr 2023
  3. Primary completion21 Feb 2024
  4. Study completion21 Feb 2024

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
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05858047
Sponsor's protocol ID
SYHX1902-002
Status last verified
Apr 2024
First submitted
3 Mar 2023
Last updated
30 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SYHX1901 in people with Effects, Drug Side, run by CSPC Ouyi 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 9 inclusion and 55 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 30 Apr 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 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?

Percentage of Participants Achieving a Psoriasis Area and Severity Index Score ≥75% (PASI 75) response (time frame: Week 12). 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 NCT05858047.

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 30 Apr 2024.

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