PsoriasisPhase 3NCT07724366
A Clinical Trial of TQH3906 Capsules in Adult Patients With Moderate to Severe Plaque Psoriasis
A Phase 3 study testing TQH3906 capsules and Deucravacitinib tablets 6 mg in people with Psoriasis, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 45 sites in China.
Trial summary
This study is a multicenter, randomized, double-blind, placebo- and active-controlled Phase III clinical trial sponsored by Nanjing Shunxin Pharmaceutical Co., Ltd., a subsidiary of Chiatai Tianqing Pharmaceutical Group. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- TQH3906 capsules and Deucravacitinib tablets 6 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 45 sitesChina
- Study dates
- 2 Sep 2026to Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
Inclusion Criteria:1. Participants must be between 18 and 75 years old when signing the informed consent form (ICF), regardless of gender; 2. Confirmed diagnosis of plaque psoriasis for at least 6 months at screenin 3. Disease is stable at screening and baseline visits, and the following criteria are met:
- Static Physician Global Assessment (sPGA) score ≥3;
- Psoriasis Area and Severity Index (PASI) score ≥12;
- Body Surface Area (BSA) affected by psoriasis ≥10%; 4. Deemed by the Investigator as suitable for systemic therapy or phototherapy; 5. Women of childbearing potential must have a negative pregnancy test at screening and baseline visits. Women of childbearing potential and male trial participants whose spouse or partner is a woman of childbearing potential must be willing to use at least one effective method of contraception as specified in the protocol during the study period (from signing the ICF until 30 days after the last dose of investigational drug). Male trial participants must also commit to not donating sperm during the study period and within 30 days after the last dose of study drug; 6. Before initiating any screening or study-specific procedures, trial participants must be able to understand and willing to comply with all protocol requirements, and voluntarily sign and date the ICF.
Exclusion Criteria:1.Presence of non-plaque psoriasis during the Screening period or at the Baseline visit; 2.Past or current diagnosis of drug-induced psoriasis; 3.Concomitant other autoimmune diseases, including but not limited to rheumatoid arthritis, sarcoidosis, and systemic lupus erythematosus; 4.Receiving therapeutic agents for psoriatic arthritis (PsA) other than stable-dose non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics.
5.Prior exposure to TQH3906 Capsules or Deucravacitinib Tablets; 6.Receipt of any of the following medications or treatments within the specified time window:
- Any topical agents or treatments that may interfere with psoriasis assessment, administered within 2 weeks before the Baseline visit;
- Psoriasis phototherapy administered within 4 weeks before the Baseline visit;
- Any biologics or biosimilars thereof, administered within the specified time frame before the Baseline visit;
- Systemic non-biologic psoriasis therapy and/or systemic immunosuppressive treatment administered within 4 weeks before the Baseline visit; 5) Within 6 months prior to the baseline visit: Leflunomide; 6) Within 4 weeks prior to the baseline visit: Traditional Chinese medicines (TCM), Chinese proprietary medicines, or herbal preparations used for psoriasis treatment or with unknown composition/nature, including but not limited to Total Glucosides of Paeony, Tripterygium wilfordii preparations, Compound Glycyrrhizin preparations, Compound Qingdai preparations, etc.; 7) Within 4 weeks prior to the baseline visit: Any live vaccines or live-attenuated vaccines; OR anticipated need to receive live vaccines or live-attenuated vaccines during the study period including at least 4 weeks after the last dose of investigational product; 8) Within 3 months prior to the baseline visit (or 5 half-lives, whichever is longer): Investigational biological agent treatment; OR within 30 days prior to the baseline visit (or 5 half-lives, whichever is longer): Any other investigational drug treatment; OR currently participating in other clinical trials; 7. Active infection/history of infection, or receipt of specific anti-infective therapies within the specified time windows; 8. Previous or current presence of severe or unstable diseases or medical conditions involving neurological, cardiovascular, respiratory, digestive, urinary, hematological, or immune systems that, in the Investigator's judgment, may interfere with outcome assessment or affect participation safety 9. Laboratory test abnormalities meeting any of the following criteria during the screening period: 1) Hemoglobin <90.0 g/L; 2) White blood cell count <3.0×10⁹/L; 3) Neutrophil count <1.0×10⁹/L; 4) Lymphocyte count <0.5×10⁹/L; 5) Platelet count <100×10⁹/L; 6) Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) >3× Upper Limit of Normal (ULN); 7) Total bilirubin (TBIL) >1.5× ULN; 8) Estimated creatinine clearance <45 mL/min calculated based on the Cockcroft-Gault formula. (See Appendix 2 for calculation formula); 9) Thyroid-stimulating hormone (TSH) outside the normal reference range, concomitant with free T4 or T3 also outside the normal reference range.
- History of drug or alcohol abuse within 6 months prior to screening; 11. Known allergy, hypersensitivity, or intolerance to TQH3906 capsules, deucravacitinib tablets, or any excipient ingredients; 12. Women who are pregnant, breastfeeding, or planning to become pregnant during the trial, and men who plan to father children or donate sperm during the trial; 13. Trial participants who are employees of the Sponsor, third-party agency staff, or direct research center staff involved in this study or their family members; 14. Per Investigator assessment, presence of any other medical, psychiatric, or other reasons that render the trial participant unsuitable for participation in this study.
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Trial locations and contacts
45 sites in 1 country. Contact the study team or a site near you to ask about taking part.
45 sites in 1 country
China45 sites, 43 recruiting
- Not yet recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
wenhui wang, Doctor, 18618269437, wangwenhui@puh3.net.cn
- Not yet recruiting
The Second Hospital of Jilin University
Changchun, Jilin, 130000
Fuqiu Wang, Doctoral candidate, 13039123758, Lifuqiu1234@126.com
- Not yet recruiting
Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Juan Su, Doctor, 15116408921, 3694944834@qq.com
- Recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
Lina Tan, Doctor, 13973162345, tanlinawork@163.com
- Not yet recruiting
The Second People's Hospital of ChangZhi
Changzhi, Shanxi, 46000
Yufei Li, Bachelor, 15635580696, 119023217@qq.com
- Recruiting
Affiliated Hospital of Chengde Medical University
Chengde, Hebei, 067000
Xinsuo Duan, Master, 15633142680, 15633142680@126.com
- Not yet recruiting
The First Affiliated Hospital of Chongqing Medical University 。
Chongqing, Chongqing Municipality, 400010
Kun Huang, Doctor, 13883688696, feelingkun@126.com
- Not yet recruiting
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Chongqing Municipality, 400011
Qingchun Diao, Doctor, 13983735555, qchdiao@vip.sina.com
- Recruiting
Qilu Hospital Dezhou Branch of Shandong University (Dezhou People's Hospital)
Dezhou, Shandong, 253000
Jun Peng, Bachelor, 18553498197, 13881702998@163.com
- Not yet recruiting
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, 510000
Xiaohua Wang, Doctor, 13763359607, wxh_21773@163.com
- Not yet recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 519041
Zhu Shen, Doctor, 13983174426, zhshencq@163.com
- Not yet recruiting
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550002
Xue Chen, Doctor, 18685993699, cxe911@qq.com
- Not yet recruiting
Hainan Fifth People's Hospital
Haikou, Hainan, 570100
Huiming Zeng, Master, 13976598200, 13976598200@163.com
- Recruiting
Heilongjiang Provincial Hospital
Harbin, Heilongjiang, 150036
Xiguang Liu, Bachelor, 13945675477, liuxiguang5741@163.com
- Not yet recruiting
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 10010
Xinxiang Lv, Bachelor, 13171069661, lxx_08@126.com
- Not yet recruiting
Jiaxing First Hospital
Jiaxing, Zhejiang, 314001
Wenhao Yin, master, 13957323606, whyin69@sina.com
- Recruiting
Jingzhou Central Hospital
Jingzhou, Hubei, 434020
Yi Sun, Doctor, 18071883358, jzzxyysy@163.com
- Recruiting
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, 321000
Meiyan wang, Bachelor, 13757984755, wmy196501@163.com
- Not yet recruiting
Jining No.1 People'S Hospital
Jining, Shandong, 272011
Dongmei Shi, Doctor, 15069760108, shidongmei28@163.com
- Not yet recruiting
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
Ying Tu, Doctor, 13608711764, 747307239@qq.com
- Not yet recruiting
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu, 222061
Hong Ren, Bachelor, 18961326020, doctorrenh@126.com
- Not yet recruiting
The Second Affiliated Hospital of Henan University of science and technology
Luoyang, Henan, 471099
Xinggang Ju, Master, 15225538050, jxgwfmc@126.com
- Withdrawn
Chinese Academy of Medical Sciences Hospital for Skin Diseases
Nanjing, Jiangsu, 210042
- Not yet recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Qiuju Li, Doctor, 15807816066, llqj000@126.com
- Not yet recruiting
Nantong Cancer Hospital
Nantong, Jiangsu, 215004
Zhichun Liu, Doctor, 1377194276, lzchun5190@sina.com
- Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315020
Bingjiang Lin, Master, 17757461212, linbingj@163.com
- Not yet recruiting
Puyang Oilfield General Hospital
Puyang, Henan, 457001
QiJun Li, Master, 13839277965, lqj_2008@163.com
- Not yet recruiting
Qingdao Municipal Hospital
Qingdao, Shandong, 266000
Changyuan Wang, Doctor, 18660290075, changyuanwang2008@163.com
- Not yet recruiting
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
Zhenghua Zhang, Doctor, 13918416280, verzhang@foxmail.com
- Recruiting
Zhongyi Northeast International Hospital Co., Ltd.
Shengyang, Liaoning, 110623
Shifa Zhang, Doctor, 13190010100, zhangshifa_1963@126.com
- Recruiting
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110002
Xinghua Gao, Doctor, 13940152467, gaobarry@hotmail.com
- Withdrawn
Shenyang Seventh People's Hospital (Shenyang Hospital of Integrated Traditional Chinese and Western Medicine, Shenyang Dermatology Hospital)
Shenyang, Liaoning, 110003
- Not yet recruiting
Central Hospital Affiliated to Shenyang Medical College
Shenyang, Liaoning, 110023
Xiaodong Li, Doctor, 18002478468, lilicmu@163.com
- Recruiting
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518032
Cuihong Lian, Doctor, 15814692161, 15814692161@163.com
- Not yet recruiting
Shijiazhuang Traditional Chinese Medicine Hospital
Shijiazhuang, Hebei, 050000
Ling'e Li, Bachelor, 13323043660, zyypfk2008@126.com
- Recruiting
Suining Central Hospital
Suining, Sichuan, 629000
Fei Ouyang, Master, 15982006350, 945951644@qq.com
- Recruiting
Suzhou Municipal Hospital
Suzhou, Jiangsu, 215002
Jun Gu, Master, 18930939371, gujun79@163.com
- Not yet recruiting
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, 300110
Sanwu Zeng, Master, 13702066935, 13702066935@139.com
- Not yet recruiting
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, Tianjin Municipality, 300120
Litao Zhang, Doctor, 18602228122, ZhanglitaoYG@163.com
Junying Li, Doctor, 13512270412, Lijunying2016@126.com
- Not yet recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710004
Songmei Geng, Doctor, 13060423612, gsm12@yahoo.com
- Not yet recruiting
The First People's Hospital of Xining
Xining, Qinghai, 810000
Hengjin Li, Bachelor, 13911333214, lhengjin@163.com
- Not yet recruiting
Gerneral Hospital of Ningxia Medical Univercity
Yinchuan, The Ningxia Hui Autonomous Region, 750000
Nan Yu, Master, 13895095009, 13895095009@163.com
- Not yet recruiting
Zhengzhou Central Hospital
Zhengzhou, Henan, 450000
Yuhong Zhang, Master, 15837180902, zyhdyxiang@126.com
- Not yet recruiting
The First Peopel's Hospital of Zhengzhou
Zhengzhou, Henan, 450004
Ziguang Zhou, Master, 15237167989, zzg2006619@126.com
- Recruiting
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212008
Hui Xu, Doctor, 13815474886, xuhuiraian@sina.com
About this study
Official title: A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of TQH3906 Capsules in the Treatment of Adult Patients With Moderate to Severe Plaque Psoriasis
This study is a multicenter, randomized, double-blind, placebo- and active-controlled Phase III clinical trial sponsored by Nanjing Shunxin Pharmaceutical Co., Ltd., a subsidiary of Chiatai Tianqing Pharmaceutical Group. The study aims to evaluate the efficacy and safety of once-daily oral TQH3906 capsules (24 mg) in adult participants with moderate to severe plaque psoriasis. TQH3906 is a highly selective TYK2 allosteric inhibitor targeting the JH2 domain, which blocks the IL-23 and Type I interferon inflammatory pathways. Approximately 400 eligible participants aged 18-75 years will be enrolled. Participants will be stratified based on prior biologic use and randomized in a 2:2:1 ratio to the TQH3906 group, the deucravacitinib active control group, or the placebo group. The trial includes a screening period, a 16-week double-blind controlled treatment phase, a 36-week open-label extension phase (during which all participants will receive TQH3906), and a 4-week safety follow-up after the last dose. The co-primary endpoints are the proportion of participants achieving sPGA 0/1 and PASI 90 response at Week 16. Secondary endpoints include improvements in scalp, nail, and palmoplantar psoriasis, Dermatology Life Quality Index (DLQI), long-term safety, and steady-state pharmacokinetic parameters. This study will collect comprehensive efficacy and safety data over 52 weeks to support the New Drug Application (NDA) for TQH3906 for the treatment of plaque psoriasis.
- Conditions
- Psoriasis
- Being tested
- TQH3906 capsules, Deucravacitinib tablets 6 mg, TQH3906 Capsules placebo, Deucravacitinib tablets placebo
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQH3906 capsulesDrug
TQH3906 Capsules is an inhibitor that targets tyrosine kinase 2 (TYK2).
Deucravacitinib tablets 6 mgDrug
Deucravacitinib tablet is an inhibitor that targets tyrosine kinase 2 (TYK2).
TQH3906 Capsules placeboDrug
No pharmacologically active substance
Deucravacitinib tablets placeboDrug
No pharmacologically active substance
| Study group | Role | What they receive |
|---|---|---|
| TQH3906 Capsules + Deucravacitinib tablets placebo | Experimental | Double-blind phase: TQH3906 capsule 24 mg + deucravacitinib tablet placebo; Open-label extension phase: TQH3906 capsule 24 mg monotherapy. Receives: Drug: TQH3906 capsules; Drug: Deucravacitinib tablets placebo |
| TQH3906 Capsules placebo + Deucravacitinib tablets 6 mg | Active comparator | Double-blind phase: TQH3906 capsule placebo + deucravacitinib tablet 6 mg; Open-label extension phase: TQH3906 capsule 24 mg monotherapy. Receives: Drug: Deucravacitinib tablets 6 mg; Drug: TQH3906 Capsules placebo |
| TQH3906 Capsules placebo + Deucravacitinib tablets placebo | Placebo comparator | Double-blind phase: TQH3906 capsule placebo + Deucravacitinib tablet placebo; Open-label extension phase: TQH3906 capsule 24 mg monotherapy. Receives: Drug: TQH3906 Capsules placebo; Drug: Deucravacitinib tablets placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
static Physician's Global Assessment (sPGA)
Proportion of participants achieving sPGA 0/1 at Week 16, comparing participants using TQH3906 capsules versus placebo.
Measured: Baseline up to 16 weeks
Psoriasis Area and Severity Index (PASI)
Proportion of participants achieving PASI 90 at Week 16, comparing participants using TQH3906 capsules versus placebo.
Measured: Baseline up to 16 weeks
Secondary outcomes (38)
static Physician's Global Assessment (sPGA)
Proportion of participants achieving sPGA 0/1 at Week 16, comparing participants using TQH3906 capsules versus Deucravacitinib..
Measured: Baseline up to 16 weeks
Psoriasis Area and Severity Index (PASI)
Proportion of participants achieving PASI 90 at Week 16, comparing participants using TQH3906 capsules versus Deucravacitinib.
Measured: Baseline up to 16 weeks
Psoriasis Area and Severity Index (PASI)
Proportion of participants achieving PASI 75 at each assessment visits, comparing participants using TQH3906 capsules versus placebo.
Measured: Baseline up to 52 weeks
Psoriasis Area and Severity Index (PASI)
Proportion of participants achieving PASI 75 at each assessment visits, comparing participants using TQH3906 capsules versus Deucravacitinib.
Measured: Baseline up to 52 weeks
Psoriasis Area and Severity Index (PASI)
Proportion of participants achieving PASI 90 at each assessment visits, comparing participants using TQH3906 capsules versus placebo.
Measured: Baseline up to 52 weeks
Psoriasis Area and Severity Index (PASI)
Proportion of participants achieving PASI 90 at each assessment visits, comparing participants using TQH3906 capsules versus Deucravacitinib.
Measured: Baseline up to 52 weeks
Psoriasis Area and Severity Index (PASI)
Proportion of participants achieving PASI 100 at each assessment visits, comparing participants using TQH3906 capsules versus placebo.
Measured: Baseline up to 52 weeks
Psoriasis Area and Severity Index (PASI)
Proportion of participants achieving PASI 100 at each assessment visits, comparing participants using TQH3906 capsules versus Deucravacitinib.
Measured: Baseline up to 52 weeks
Psoriasis Area and Severity Index (PASI)
Proportion of participants achieving PASI 50 at each assessment visits, comparing participants using TQH3906 capsules versus placebo.
Measured: Baseline up to 52 weeks
Psoriasis Area and Severity Index (PASI)
Proportion of participants achieving PASI 50 at each assessment visits, comparing participants using TQH3906 capsules versus Deucravacitinib.
Measured: Baseline up to 52 weeks
Psoriasis Area and Severity Index (PASI)
Change from baseline in PASI scores and percent change at each assessment visit; comparing participants using TQH3906 capsules versus placebo.
Measured: Baseline up to 52 weeks
Psoriasis Area and Severity Index (PASI)
Change from baseline in PASI scores and percent change at each assessment visit; comparing participants using TQH3906 capsules versus Deucravacitinib.
Measured: Baseline up to 52 weeks
Psoriasis Area and Severity Index (PASI)
The proportion of trial participants achieving PASI score < 3 at each assessment visits, comparing participants using TQH3906 capsules versus placebo.
Measured: Baseline up to 52 weeks
Psoriasis Area and Severity Index (PASI)
The proportion of trial participants achieving PASI score < 3 at each assessment visits, comparing participants using TQH3906 capsules versus Deucravacitinib.
Measured: Baseline up to 52 weeks
static Physician's Global Assessment (sPGA)
Proportion of participants achieving sPGA 0/1 at each assessment visits, comparing participants using TQH3906 capsules versus placebo.
Measured: Baseline up to 52 weeks
static Physician's Global Assessment (sPGA)
Proportion of participants achieving sPGA 0/1 at each assessment visits, comparing participants using TQH3906 capsules versus Deucravacitinib..
Measured: Baseline up to 52 weeks
static Physician's Global Assessment (sPGA)
Proportion of participants achieving sPGA 0 at each assessment visits, comparing participants using TQH3906 capsules versus placebo.
Measured: Baseline up to 52 weeks
Scalp static Physician's Global Assessment (sPGA)
Proportion of participants achieving sPGA 0 at each assessment visits, comparing participants using TQH3906 capsules versus Deucravacitinib..
Measured: Baseline up to 52 weeks
Scalp static Physician's Global Assessment (ssPGA)
Proportion of participants achieving ssPGA 0/1 at each assessment visits, comparing participants using TQH3906 capsules versus placebo.
Measured: Baseline up to 52 weeks
Scalp static Physician's Global Assessment (ssPGA)
Proportion of participants achieving ssPGA 0/1 at each assessment visits, comparing participants using TQH3906 capsules versus Deucravacitinib..
Measured: Baseline up to 52 weeks
Palmoplantar Psoriasis Physician Global Assessment (pp-PGA)
Proportion of participants achieving ssPGA 0/1 at each assessment visits, comparing participants using TQH3906 capsules versus placebo.
Measured: Baseline up to 52 weeks
Palmoplantar Psoriasis Physician Global Assessment (pp-PGA)
Proportion of participants achieving pp-PGA 0/1 at each assessment visits, comparing participants using TQH3906 capsules versus Deucravacitinib..
Measured: Baseline up to 52 weeks
Physician's Global Assessment of Fingernail Psoriasis (PGA-F)
Proportion of participants achieving PGA-F 0/1 at each assessment visits, comparing participants using TQH3906 capsules versus placebo.
Measured: Baseline up to 52 weeks
Physician's Global Assessment of Fingernail Psoriasis (PGA-F)
Proportion of participants achieving PGA-F 0/1 at each assessment visits, comparing participants using TQH3906 capsules versus Deucravacitinib.
Measured: Baseline up to 52 weeks
Dermatology Life Quality Index (DLQI)
Change from baseline in Dermatology Life Quality Index (DLQI) at each assessment visit;comparing participants using TQH3906 capsules versus placebo.
Measured: Baseline up to 52 weeks
Dermatology Life Quality Index (DLQI)
Change from baseline in Dermatology Life Quality Index (DLQI) at each assessment visit;comparing participants using TQH3906 capsules versus Deucravacitinib.
Measured: Baseline up to 52 weeks
Dermatology Life Quality Index (DLQI)
Proportion of participants achieving DLQI 0/1 at each assessment visit;comparing participants using TQH3906 capsules versus placebo.
Measured: Baseline up to 52 weeks
Dermatology Life Quality Index (DLQI)
Proportion of participants achieving DLQI 0/1 at each assessment visit;comparing participants using TQH3906 capsules versus Deucravacitinib.
Measured: Baseline up to 52 weeks
Psoriatic Lesion Body Surface Area (BSA)
Change from baseline in Psoriatic Lesion Body Surface Area (BSA) at each assessment visit; comparing participants using TQH3906 capsules versus placebo.
Measured: Baseline up to 52 weeks
Psoriatic Lesion Body Surface Area (BSA)
Change from baseline in Psoriatic Lesion Body Surface Area (BSA) at each assessment visit; comparing participants using TQH3906 capsules versus Deucravacitinib.
Measured: Baseline up to 52 weeks
Effects on participants' Psoriasis Area and Severity Index (PASI)
Questionnaire: Psoriasis Area and Severity Index (PASI) total score, range 0-72. The body is divided into 4 regions (head, upper extremities, trunk, lower extremities) weighted by 0.1, 0.2, 0.3, 0.4 respectively. Each region is scored for erythema, induration, desquamation (0-4 each) and lesion area (0-6). Higher scores indicate more severe psoriasis.
Measured: Baseline up to 52 weeks
Effects on participants' static Physician's Global Assessment (sPGA)
Questionnaire: Static Physician's Global Assessment (sPGA) is a single-item static global severity scale (0-4 points) assessing overall psoriasis lesion severity at a single timepoint, based on equal-weighted evaluation of 3 lesion features: erythema, induration, desquamation (each scored 0-4, averaged to final global score).
Scoring grading:
0 = Cleared (no active lesions, residual pigmentation allowed)
- = Almost cleared
- = Mild
- = Moderate
- = Severe sPGA 0/1 responder = score 0 or 1 at target visit;
Measured: Baseline up to 52 weeks
Effects on participants' Scalp static Physician's Global Assessment (ssPGA)
Questionnaire: ssPGA is a static 5-point single-item scale (0 to 4) exclusively evaluating scalp psoriatic lesions, comprehensively and equally assessing three lesion features: erythema, plaque induration/thickening, and scaling limited to scalp only.
Scoring grading:
0 = Clear
- = Almost clear
- = Mild
- = Moderate
- = Severe
Measured: Baseline up to 52 weeks
Effects on participants' Palmoplantar Psoriasis Physician Global Assessment (pp-PGA)
Questionnaire: Palmoplantar Psoriasis Physician Global Assessment (pp-PGA). is a static single-item 5-point scale (score range 0-4), exclusively evaluating plaque psoriasis lesions limited to palms and soles. Investigators equally assess three core lesion features: erythema, hyperkeratosis/induration, scaling (fissures/pain secondary to plaques are referenced as auxiliary manifestations).
Grading definition:
0 = Clear
- = Almost clear
- = Mild
- = Moderate
- = Severe
Measured: Baseline up to 52 weeks
Effects on participants' Physician's Global Assessment of Fingernail Psoriasis (PGA-F)
Questionnaire: Physician's Global Assessment of Fingernail Psoriasis (PGA-F) is a static single-item 5-point scale (score range 0-4), exclusively evaluating psoriatic lesions of all fingernails. Investigators comprehensively assess core nail psoriasis manifestations: nail pitting, onycholysis, subungual hyperkeratosis, splinter hemorrhages, nail discoloration, crumbling.
Grading definition:
0 = Clear
- = Almost clear
- = Mild
- = Moderate
- = Severe
Measured: Baseline up to 52 weeks
Effects on participants' Dermatology Life Quality Index (DLQI)
Questionnaire: The Dermatology Life Quality Index (DLQI) is a validated self-administered 10-item patient-reported questionnaire evaluating the impact of skin disease on quality of life over the prior 7 days. The scale covers 6 domains: symptoms \& feelings, daily activities, leisure, work/school, personal relationships, treatment burden. Each question is scored 0 (not at all/not relevant) to 3 (very much); total score ranges from 0 to 30. Lower scores indicate less impairment to quality of life.
Measured: Baseline up to 52 weeks
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) ,Adverse Events of Special Interest (AESIs) and treatment-related adverse events (TEAEs).
Measured: Baseline up to 56 weeks
Plasma concentration of TQH3906 at steady state (Cav, SS)
The plasma concentration at which the rate of administration and rate of elimination are in equilibrium.
Measured: 1 hour Pre-dose of day 1 and 30 minutes Pre-dose of day 29, day 57, day 113, day 225, day 365 during treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start2 Sep 2026
- Primary completionSep 2027 (estimated)
- Study completionJun 2028 (estimated)
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.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724366
- Sponsor's protocol ID
- TQH3906-III-01
- Status last verified
- Sep 2026
- First submitted
- 21 Jul 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of TQH3906 Capsules in the Treatment of Adult Patients With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT07724366
- Acronym / sponsor ID
- TQH3906-III-01
- Conditions
- Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Sep 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 24 Jul 2026 (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.
This study is a multicenter, randomized, double-blind, placebo- and active-controlled Phase III clinical trial sponsored by Nanjing Shunxin Pharmaceutical Co., Ltd., a subsidiary of Chiatai Tianqing Pharmaceutical Group. The study aims to evaluate the efficacy and safety of once-daily oral TQH3906 capsules (24 mg) in adult participants with moderate to severe plaque psoriasis. TQH3906 is a highly selective TYK2 allosteric inhibitor targeting the JH2 domain, which blocks the IL-23 and Type I interferon inflammatory pathways. Approximately 400 eligible participants aged 18-75 years will be enrolled. Participants will be stratified based on prior biologic use and randomized in a 2:2:1 ratio to the TQH3906 group, the deucravacitinib active control group, or the placebo group. The trial includes a screening period, a 16-week double-blind controlled treatment phase, a 36-week open-label extension phase (during which all participants will receive TQH3906), and a 4-week safety follow-up after the last dose. The co-primary endpoints are the proportion of participants achieving sPGA 0/1 and PASI 90 response at Week 16. Secondary endpoints include improvements in scalp, nail, and palmoplantar psoriasis, Dermatology Life Quality Index (DLQI), long-term safety, and steady-state pharmacokinetic parameters. This study will collect comprehensive efficacy and safety data over 52 weeks to support the New Drug Application (NDA) for TQH3906 for the treatment of plaque psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TQH3906 Capsules + Deucravacitinib tablets placebo | Experimental | Drug: TQH3906 capsules, Drug: Deucravacitinib tablets placeboDouble-blind phase: TQH3906 capsule 24 mg + deucravacitinib tablet placebo; Open-label extension phase: TQH3906 capsule 24 mg monotherapy. |
| TQH3906 Capsules placebo + Deucravacitinib tablets 6 mg | Active comparator | Drug: Deucravacitinib tablets 6 mg, Drug: TQH3906 Capsules placeboDouble-blind phase: TQH3906 capsule placebo + deucravacitinib tablet 6 mg; Open-label extension phase: TQH3906 capsule 24 mg monotherapy. |
| TQH3906 Capsules placebo + Deucravacitinib tablets placebo | Placebo comparator | Drug: TQH3906 Capsules placebo, Drug: Deucravacitinib tablets placeboDouble-blind phase: TQH3906 capsule placebo + Deucravacitinib tablet placebo; Open-label extension phase: TQH3906 capsule 24 mg monotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| TQH3906 capsulesTQH3906 Capsules is an inhibitor that targets tyrosine kinase 2 (TYK2). | Drug | TQH3906 Capsules + Deucravacitinib tablets placebo |
| Deucravacitinib tablets 6 mgDeucravacitinib tablet is an inhibitor that targets tyrosine kinase 2 (TYK2). | Drug | TQH3906 Capsules placebo + Deucravacitinib tablets 6 mg |
| TQH3906 Capsules placeboNo pharmacologically active substance | Drug | TQH3906 Capsules placebo + Deucravacitinib tablets 6 mg, TQH3906 Capsules placebo + Deucravacitinib tablets placebo |
| Deucravacitinib tablets placeboNo pharmacologically active substance | Drug | TQH3906 Capsules + Deucravacitinib tablets placebo, TQH3906 Capsules placebo + Deucravacitinib tablets placebo |
Primary outcome
static Physician's Global Assessment (sPGA)
Time frame: Baseline up to 16 weeks
Proportion of participants achieving sPGA 0/1 at Week 16, comparing participants using TQH3906 capsules versus placebo.
Psoriasis Area and Severity Index (PASI)
Time frame: Baseline up to 16 weeks
Proportion of participants achieving PASI 90 at Week 16, comparing participants using TQH3906 capsules versus placebo.
38 secondary outcomes
static Physician's Global Assessment (sPGA)
Time frame: Baseline up to 16 weeks
Psoriasis Area and Severity Index (PASI)
Time frame: Baseline up to 16 weeks
Psoriasis Area and Severity Index (PASI)
Time frame: Baseline up to 52 weeks
Psoriasis Area and Severity Index (PASI)
Time frame: Baseline up to 52 weeks
Psoriasis Area and Severity Index (PASI)
Time frame: Baseline up to 52 weeks
Psoriasis Area and Severity Index (PASI)
Time frame: Baseline up to 52 weeks
Psoriasis Area and Severity Index (PASI)
Time frame: Baseline up to 52 weeks
Psoriasis Area and Severity Index (PASI)
Time frame: Baseline up to 52 weeks
Psoriasis Area and Severity Index (PASI)
Time frame: Baseline up to 52 weeks
Psoriasis Area and Severity Index (PASI)
Time frame: Baseline up to 52 weeks
Psoriasis Area and Severity Index (PASI)
Time frame: Baseline up to 52 weeks
Psoriasis Area and Severity Index (PASI)
Time frame: Baseline up to 52 weeks
Psoriasis Area and Severity Index (PASI)
Time frame: Baseline up to 52 weeks
Psoriasis Area and Severity Index (PASI)
Time frame: Baseline up to 52 weeks
static Physician's Global Assessment (sPGA)
Time frame: Baseline up to 52 weeks
static Physician's Global Assessment (sPGA)
Time frame: Baseline up to 52 weeks
static Physician's Global Assessment (sPGA)
Time frame: Baseline up to 52 weeks
Scalp static Physician's Global Assessment (sPGA)
Time frame: Baseline up to 52 weeks
Scalp static Physician's Global Assessment (ssPGA)
Time frame: Baseline up to 52 weeks
Scalp static Physician's Global Assessment (ssPGA)
Time frame: Baseline up to 52 weeks
Palmoplantar Psoriasis Physician Global Assessment (pp-PGA)
Time frame: Baseline up to 52 weeks
Palmoplantar Psoriasis Physician Global Assessment (pp-PGA)
Time frame: Baseline up to 52 weeks
Physician's Global Assessment of Fingernail Psoriasis (PGA-F)
Time frame: Baseline up to 52 weeks
Physician's Global Assessment of Fingernail Psoriasis (PGA-F)
Time frame: Baseline up to 52 weeks
Dermatology Life Quality Index (DLQI)
Time frame: Baseline up to 52 weeks
Dermatology Life Quality Index (DLQI)
Time frame: Baseline up to 52 weeks
Dermatology Life Quality Index (DLQI)
Time frame: Baseline up to 52 weeks
Dermatology Life Quality Index (DLQI)
Time frame: Baseline up to 52 weeks
Psoriatic Lesion Body Surface Area (BSA)
Time frame: Baseline up to 52 weeks
Psoriatic Lesion Body Surface Area (BSA)
Time frame: Baseline up to 52 weeks
Effects on participants' Psoriasis Area and Severity Index (PASI)
Time frame: Baseline up to 52 weeks
Effects on participants' static Physician's Global Assessment (sPGA)
Time frame: Baseline up to 52 weeks
Effects on participants' Scalp static Physician's Global Assessment (ssPGA)
Time frame: Baseline up to 52 weeks
Effects on participants' Palmoplantar Psoriasis Physician Global Assessment (pp-PGA)
Time frame: Baseline up to 52 weeks
Effects on participants' Physician's Global Assessment of Fingernail Psoriasis (PGA-F)
Time frame: Baseline up to 52 weeks
Effects on participants' Dermatology Life Quality Index (DLQI)
Time frame: Baseline up to 52 weeks
Adverse event rate
Time frame: Baseline up to 56 weeks
Plasma concentration of TQH3906 at steady state (Cav, SS)
Time frame: 1 hour Pre-dose of day 1 and 30 minutes Pre-dose of day 29, day 57, day 113, day 225, day 365 during treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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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.
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TQH3906 capsules and Deucravacitinib tablets 6 mg in people with Psoriasis, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 45 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?
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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinghua Gao, Doctor (13940152467, gaobarry@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
static Physician's Global Assessment (sPGA) (time frame: Baseline up to 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2026.