A Phase 3 interventional study of TQH3906 capsules and Deucravacitinib tablets 6 mg in Psoriasis, sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.. Recruiting at 45 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment
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.
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:
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:
10. 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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Double-blind phase: TQH3906 capsule 24 mg + deucravacitinib tablet placebo; Open-label extension phase: TQH3906 capsule 24 mg monotherapy.
Drug: TQH3906 capsules · Drug: Deucravacitinib tablets placebo
Double-blind phase: TQH3906 capsule placebo + deucravacitinib tablet 6 mg; Open-label extension phase: TQH3906 capsule 24 mg monotherapy.
Drug: Deucravacitinib tablets 6 mg · Drug: TQH3906 Capsules placebo
Double-blind phase: TQH3906 capsule placebo + Deucravacitinib tablet placebo; Open-label extension phase: TQH3906 capsule 24 mg monotherapy.
Drug: TQH3906 Capsules placebo · Drug: Deucravacitinib tablets placebo
TQH3906 Capsules is an inhibitor that targets tyrosine kinase 2 (TYK2).
Deucravacitinib tablet is an inhibitor that targets tyrosine kinase 2 (TYK2).
No pharmacologically active substance
No pharmacologically active substance
static Physician's Global Assessment (sPGA)
Proportion of participants achieving sPGA 0/1 at Week 16, comparing participants using TQH3906 capsules versus placebo.
Time frame: 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.
Time frame: Baseline up to 16 weeks
static Physician's Global Assessment (sPGA)
Proportion of participants achieving sPGA 0/1 at Week 16, comparing participants using TQH3906 capsules versus Deucravacitinib..
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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..
Time frame: 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.
Time frame: 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..
Time frame: 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.
Time frame: 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..
Time frame: 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.
Time frame: 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..
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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) 1. = Almost cleared 2. = Mild 3. = Moderate 4. = Severe sPGA 0/1 responder = score 0 or 1 at target visit;
Time frame: 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 1. = Almost clear 2. = Mild 3. = Moderate 4. = Severe
Time frame: 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 1. = Almost clear 2. = Mild 3. = Moderate 4. = Severe
Time frame: 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 1. = Almost clear 2. = Mild 3. = Moderate 4. = Severe
Time frame: 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.
Time frame: 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).
Time frame: 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.
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.
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Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.