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Treatment of Moderate to Severe Plaque Psoriasis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Treatment of Moderate to Severe Plaque Psoriasis

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

NCT06542614•Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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:
•1. 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;
•2. Positive for HIV antibody during the screening period, or have a history of HIV infection in the past;
•3. Positive Treponema pallidum antibody and positive non-Treponema pallidum serum test (RPR or TRUST) during the screening period;
•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;
+26 more criteria

Locations (35)

The Second Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, China

The first affiliated hospital of chongqing medical university

Chongqing, Chongqing Municipality, China

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, China

Liuzhou People'S Hospital

Liuchow, Guangxi, China

Shijiazhuang Hospital of Traditional Chinese Medicine

Shijiazhuang, Hebei, China

The Second Hospital of HeBei Medical University

Shijiazhuang, Hebei, China

The Second Affiliated Hospital Of Xingtai Medical Colledge

Xingtai, Hebei, China

Heilongjiang Provincial Hospital

Harbin, Heilongjiang, China

The Second Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Key Dates

Start Date

August 27, 2024

Primary Completion Date

November 3, 2025

Completion Date

December 6, 2025

Last Updated

January 30, 2026

Enrollment

209

ACTUAL participants

Conditions

Plaque Psoriasis

Interventions

TQH3906 capsules

DRUG

Placebo of TQH3906 capsules

DRUG

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An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Treatment of Moderate to Severe Plaque Psoriasis

Inclusion Criteria

Exclusion Criteria

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

A Study to Evaluate Effectiveness and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis