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Plaque PsoriasisPhase 2NCT06542614

Treatment of Moderate to Severe Plaque Psoriasis

A Phase 2 study testing TQH3906 capsules in people with Plaque Psoriasis, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 35 sites 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

To assess the efficacy and safety of TQH3906 in subjects with moderate to severe plaque psoriasis, as well as the PK and PD characteristics of multiple doses Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Plaque Psoriasis
What is being tested?
TQH3906 capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
209 participants
Where
35 sitesChina
Study dates
27 Aug 2024to 6 Dec 2025
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be 18-70 years old (both 18 and 70 years old), regardless of gender；
  • Clinically diagnosed with stable moderate to severe plaque psoriasis with a history ≥ 6 months (from randomization), and no morphological changes in skin lesions or significant disease outbreaks as assessed by the investigator;
  • Appropriate for systemic therapy or phototherapy as judged by the investigator;
  • At screening and baseline, the PASI score was ≥ 12 points, the BSA ≥ 10%, and the sPGA ≥ 3 points ;
  • Have a full understanding of this study, voluntarily participate in the trial, and have signed a written informed consent form;
  • Subjects (including partners) are willing to voluntarily use appropriate and effective contraceptive measures from screening to 3 months after the last dose of study drug.

Who cannot join

  • Pregnant and lactating females;
  • Have other forms of psoriasis other than plaque psoriasis (e.g., guttate psoriasis, generalized pustular psoriasis, erythrodermic psoriasis, arthropathic psoriasis);
  • Presence of serovirological abnormalities during the screening period:
  • Active hepatitis, or hepatitis B surface antigen (HBsAg) positive, or hepatitis B core antibody (HBcA positive and Hepatitis B virus (HBV) DNA positive, or Hepatitis C virus (HCV) antibody positive and HCV-RNA positive;
  • Positive for HIV antibody during the screening period, or have a history of HIV infection in the past;
  • Positive Treponema pallidum antibody and positive non-Treponema pallidum serum test (RPR or TRUST) during the screening period;
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  • Have a history of active tuberculosis during the screening period or before, or have latent tuberculosis infection found at screening (refers to T-SPOT positive without clinical manifestations). (Note: Patients with latent tuberculosis infection can be re-screened 1 month after starting prophylaxis according to the guidelines, and in order to continue to participate in the study, patients must agree to continue to complete the prophylactic regimen during the study, but rifampicin treatment should be avoided.) ;
  • Has a history of severe herpes zoster or herpes simplex infection, including but not limited to herpetic encephalitis, disseminated herpes simplex, generalized herpes zoster;
  • History of severe bacterial, fungal or viral infection within 2 months prior to randomization, requiring hospitalization for intravenous antibiotics or antiviral drug treatment;
  • Live vaccine within 4 weeks prior to randomization or planned live vaccine during the study;
  • Clinically significant infection, including but not limited to upper respiratory tract infection, lower respiratory tract infection, herpes simplex, herpes zoster, during the screening period, and requiring antibiotic or antiviral medication treatment;
  • Has any significant illness or unstable clinical condition (such as renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, psychiatric, neurological, immune, or locally active infectious/infectious disease) that is judged by the investigator to be unsuitable for participation in this study.
  • Abnormal laboratory tests during the screening period:
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 times upper limit of normal (ULN);
  • Hemoglobin <90g/L;
  • White blood cell count< 3.0×109/L;
  • Neutrophil count<1.0×109/L;
  • Lymphocyte count<0.5×109/L;
  • Platelet count < 100×109/L;
  • Total bilirubin >2 times ULN;
  • Other significant laboratory test abnormalities that, in the opinion of the investigator, the subject is not suitable for participation in this study.
  • History of malignant tumors (including carcinoma in situ) and lymphoproliferative disorders within 5 years prior to randomization;
  • Those who have received at least 6 consecutive months of anti-IL-12, IL-17, IL23 monoclonal antibody drugs (such as ustekin, secukziu, ichizzo, gusechiu, etc.) at the approved dose but have poor clinical response (defined as not achieving PASI 50 during treatment)；
  • Receipt of any other marketed or investigational biologic agent within 3 months or 5 half-lives (whichever is longer) prior to randomization;
  • Receipt of any other investigational drug in 1 month or 5 half-lives (whichever is longer) prior to randomization;
  • Those who have undergone surgical surgery within 4 weeks prior to randomization, or who plan to undergo surgical procedures during the study;
  • Those who have lost blood or donated more than 400 mL of blood within 4 weeks prior to randomization;
  • Receipt of immunoglobulin or blood products within 4 weeks prior to randomization;
  • Systemic treatment drugs or immunosuppressants for psoriasis within 4 weeks prior to randomization, including but not limited to retinoids, glucocorticoids, methotrexate, cyclosporine, azathioprine, Janus kinase (JAK) inhibitors, etc;
  • Use of strong CYP450 inducers (such as rifampicin, phenobarbital, carbamazepine, phenytoin, etc.) within 4 weeks prior to randomization;
  • Received topical or systemic phototherapy within 4 weeks prior to randomization, including but not limited to Narrow-band ultraviolet B (NB-UVB), photochemotherapy (PUVA), 308nm excimer light;
  • Use of topical drugs that may affect the severity of skin lesions in psoriasis within 2 weeks prior to randomization, including but not limited to glucocorticoids, urea, >3% salicylic acid, α or β hydroxy acids, retinoids, vitamin D3 analogues, calcineurin inhibitors, Phosphodiesterase-4 (PDE-4) inhibitors, etc. (Note: Mild emollients (without active substances such as urea, salicylic acid, α, or β hydroxy acids) are allowed to be used at all sites, but should not be used within 24 hours prior to each study visit);
  • Potential difficulty in blood collection, with a history of fainting needle and blood sickness;
  • Allergy to any of the known ingredients of the TQH3906, or any previous history of severe drug allergies.
  • Those with a history of substance abuse;
  • Has any other reasonable medical, psychiatric, or social reason that, in the opinion of the investigator, precludes participation in this study.

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

China35 sites

  • The First Affiliated Hospital of Baotou Medical College

    Baotou, Inner Mongolia, 014000

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100730

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin, 130031

  • The First People's Hospital of Changde

    Changde, Hunan, 415100

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410000

  • The first affiliated hospital of chongqing medical university

    Chongqing, Chongqing Municipality, 400042

  • Dermatology Hospital of Southern Medical University

    Guangzhou, Guangdong, 510091

  • Affiliated Hangzhou First People'S Hospital,School of Medicine, Westlake University

    Hangzhou, Zhejiang, 310003

  • The Second Affiliated Hospital Zhejiang University School Of Medicine

    Hangzhou, Zhejiang, 310009

  • Heilongjiang Provincial Hospital

    Harbin, Heilongjiang, 150036

  • Shandong First Medical University Affiliated Dermatology Hospital

    Jinan, Shandong, 250022

  • Shandong University Qilu Hospital

    Jinan, Shandong, 250063

  • Liuzhou People'S Hospital

    Liuzhou, Guangxi, 545006

  • The Second Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 471000

  • Meihekou Central Hospital

    Meihekou, Jilin, 135000

  • Hospital of Dermatology, Chinese Academy of Medical Sciences

    Nanjing, Jiangsu, 210000

  • Nanyang First People'S Hospital

    Nanyang, Henan, 473010

  • Genertec Liaoyou Gem Flower Hospital

    Panjin, Liaoning, 124000

  • Qingdao Municipal hospital (group)

    Qingdao, Shandong, 266011

  • Qingdao Traditional Chinese Medicine Hospital

    Qingdao, Shandong, 266033

  • Shanghai JiaoTong University of medicine Ruijin Hospital

    Shanghai, Shanghai Municipality, 20025

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110000

  • The first hospital of china medical university

    Shenyang, Liaoning, 110001

  • Shijiazhuang Hospital of Traditional Chinese Medicine

    Shijiazhuang, Hebei, 50000

  • The Second Hospital of HeBei Medical University

    Shijiazhuang, Hebei, 50000

  • Shiyan Renmin Hospital

    Shiyan, Hubei, 442000

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi, 030012

  • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

    Tianjin, Tianjin Municipality, 300120

  • Xinjiang Uygur Autonomous Region People's Hospital

    Ürümqi, Xinjiang, 830001

  • Wuhan First Hospital

    Wuhan, Hubei, 430033

  • The Second Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui, 241000

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710000

  • The Second Affiliated Hospital Of Xingtai Medical Colledge

    Xingtai, Hebei, 054002

  • Yancheng First People's Hospital

    Yancheng, Jiangsu, 224006

Other trials in China

About this study

Official title: A Phase II Clinical Trial to Evaluate the Efficacy, Safety, Pharmacokinetics (PK), and Pharmacodynamic (PD) Profile of TQH3906 in Subjects With Moderate to Severe Plaque Psoriasis

To assess the efficacy and safety of TQH3906 in subjects with moderate to severe plaque psoriasis, as well as the PK and PD characteristics of multiple doses

Being tested
TQH3906 capsules, Placebo of TQH3906 capsules

What participants receive

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

  • TQH3906 capsulesDrug

    To assess the efficacy and safety of TQH3906 in subjects with moderate to severe plaque psoriasis.

  • Placebo of TQH3906 capsulesDrug

    Placebo without drug substance.

Study groups in NCT06542614
Study groupRoleWhat they receive
TQH3906 capsulesExperimentalTQH3906 capsules are administered orally at the same time (±2 hours) on an empty stomach every day for 12 weeks starting from Day 1.
Receives: Drug: TQH3906 capsules
Placebo of TQH3906 capsulesPlacebo comparatorTQH3906 capsules placebo: TQH3906 capsules placebo administered orally once daily for 12 weeks at the same time (±2 hours) on an empty stomach starting from Day 1.
Receives: Drug: Placebo of TQH3906 capsules

What is being measured

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

  1. Proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75 at week 12

    Achieve a PASI 75 ratio

    Measured: Up to week 12

Secondary outcomes (17)

  1. Proportion of patients achieving Static Physician's Global Assessment (sPGA) 0/1 at week 12

    It is used to observe the proportion of patients with 0 or 1

    Measured: Up to week 12

  2. Proportion of patients achieving PASI 50 at week 12

    Observed proportion of patients achieving PASI 50 at week 12

    Measured: Up to week 12

  3. Proportion of patients achieving PASI 90 at week 12

    Observed proportion of patients achieving PASI 90 at week 12

    Measured: Up to week 12

  4. Proportion of patients achieving PASI 100 at week 12

    Observed proportion of patients achieving PASI 100 at week 12

    Measured: Up to week 12

  5. Body Surface Area (BSA) score

    To observe the degree of change from baseline in BSA score at week 12

    Measured: Up to week 12

  6. Dermatology Life Quality Index (DLQI) score

    To observe the degree of change from baseline in DLQI score at week 12

    Measured: Up to week 12

  7. Incidence of abnormal laboratory test markers

    The proportion of patients with abnormal laboratory examination indicators, including blood routine and liver function, mainly includes blood routine, liver function, etc.

    Measured: From randomization to 4 weeks after the last dose

  8. Adverse event (AE)

    Proportion of patients with adverse events, defined by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.

    Measured: From randomization to 4 weeks after the last dose

  9. Serious Adverse Events (SAEs)

    Proportion of patients with serious adverse events, defined by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.

    Measured: From randomization to 4 weeks after the last dose.

  10. Tmax, ss

    Refers to the time when the blood concentration reaches its peak after a single dose. At this point in time, the blood concentration is the highest.

    Measured: Within 1 hour before Day1, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours, Day 15, Day 29, Day 57, Day 85 within 1 hour before administration, 1,1.5, 2, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours after Day 85

  11. Cmax, ss

    The steady-state concentration of the drug after multiple doses was investigated.

    Within 1 hour before Day1, 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours, Day15, Day29, Day57, Day85 within 1 hour before administration, and 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72 hours after Day85.

    Measured: Within 1 hour before Day1, 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours, Day15, Day29, Day57, Day85 within 1 hour before administration, and 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72 hours after Day85

  12. Cmin, ss

    The lowest concentration from the initial moment after administration to the lowest concentration before the next dose when multiple doses reach steady state. This index is a common indicator to reflect the level of drug accumulation, and is closely related to the drug dose, dosing interval and drug elimination rate.

    Measured: Within 1 hour before Day1, 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours, Day15, Day29, Day57, Day85 within 1 hour before administration, and 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72 hours after Day85

  13. Area under the plasma concentration-time curve (AUC) 0-τ

    When multiple administrations reach steady state, the area under the plasma concentration curve of each dosing interval is equal to the area under the plasma concentration curve from the time after administration to infinity.

    Measured: Within 1 hour before Day1 administration, 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours, Day15, Day29, Day57, Day85 within 1 hour before administration, and 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72 hours after Day85

  14. Rac

    The ratio of the dose required to be given in one dose to the total dose required to be given in divided doses.

    Measured: Within 1 hour before Day1 administration, 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours, Day15, Day29, Day57, Day85 within 1 hour before administration, and 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72 hours after Day85

  15. Interleukin-17A (IL-17A) in serum

    Change from baseline in serum IL-17A

    Measured: Within 1 hour before Day1 administration, Day15, Day29, Day85

  16. Interleukin 19 (IL-19) in serum

    Change from baseline in serum IL-19

    Measured: Within 1 hour before Day1 administration, Day15, Day29, Day85

  17. β defensin in serum

    Change from baseline in serum β defensin

    Measured: Within 1 hour before Day1 administration, Day15, Day29, Day85

Timeline

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

  1. First posted7 Aug 2024
  2. Study start27 Aug 2024
  3. Primary completion3 Nov 2025
  4. Study completion6 Dec 2025

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
209 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06542614
Sponsor's protocol ID
TQH3906-II-01
Status last verified
Dec 2025
First submitted
5 Aug 2024
Last updated
30 Jan 2026
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 TQH3906 capsules in people with Plaque Psoriasis, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 35 sites 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 36 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 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites 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 patients achieving Psoriasis Area and Severity Index (PASI) 75 at week 12 (time frame: Up to 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 NCT06542614.

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 Jan 2026.

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