A Prospective, Interventional, Exploratory Study Evaluating the Efficacy of Small-Molecule Compound XJH05 Ointment in the Treatment of Plaque Psoriasis

NCT07780929 | Recruiting DMC

• 1 other identifier: 2025-KY-154-01
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Psoriasis is a chronic, recurrent, inflammatory, and systemic disease mediated by immunity, induced by a combination of genetic and environmental factors. Its typical clinical manifestations are scaly erythema or plaques, which may be localized or widespread. It is non-contagious, difficult to treat, and often lifelong. The etiology of psoriasis involves multiple factors, including genetics, immunity, and environment. Through an immune response primarily mediated by T lymphocytes and jointly participated in by various immune cells, it causes hyperproliferation of keratinocytes or inflammation in joint synovial cells and chondrocytes. Psoriasis is an incurable disease; however, numerous therapeutic drugs and methods are currently available. Treatment regimens should be determined based on patient symptoms: mild psoriasis is mainly treated with topical therapies, while moderate-to-severe cases can be managed with systemic therapies. Targeted biologics may be appropriately selected for patients who show an inadequate response to traditional systemic therapies. The goals of psoriasis treatment focus on controlling symptoms and improving patients' quality of life. Psoriasis is classified into different subtypes, among which plaque psoriasis is the most common subtype (accounting for approximately 90%). Among these, about 80% of psoriasis patients have mild disease, with topical drug therapy being the preferred first-line treatment. Currently, commonly used topical agents include vitamin D3 derivatives, glucocorticoids, retinoids, and topical combination preparations. Recent studies have revealed that the interaction between lipocalin-2 (LCN2) and its receptor SLC22A17 plays a key role in the pathogenesis and progression of psoriasis: the LCN2/SLC22A17 axis induces abnormal cholesterol metabolism in keratinocytes by activating the SREBP2 pathway, and acts synergistically with the NLRC4 inflammasome to trigger the release of inflammatory mediators such as IL-1$\\beta$ and IL-18. This chemoselectively recruits and activates neutrophils, establishing a continuously amplified inflammatory cascade. Notably, direct inhibitors or antagonists targeting the SLC22A17 receptor have not been fully developed in existing technologies, and reports regarding the molecular structures, selectivity, and druggability of relevant compounds remain rare. Most studies are still confined to preliminary exploration via genetic intervention or antibody blockade, lacking molecular entities that can be translated into clinical applications. By screening and validating the potential of the specific small-molecule compound XJH05 to achieve upstream intervention in psoriasis by targeting SLC22A17, we aim to provide a therapeutic solution for psoriasis that possesses both mechanistic innovation and clinical feasibility. This small-molecule drug can specifically bind to the active site of the SLC22A17 protein, blocking the interaction between SLC22A17 and LCN2. Consequently, it inhibits the activation of the LCN2-SREBP2-NLRC4 signaling axis and downregulates the expression of pro-inflammatory cytokines, thereby blocking at the molecular level both the pathological hyperproliferation of epidermal keratinocytes and the infiltration of immune cells such as neutrophils, which are characteristic features of psoriasis. Although numerous drugs and therapeutic methods are currently available for psoriasis, it remains an incurable disease. Through animal experiments and in vitro drug interventions on psoriasis patient skin lesions, we have demonstrated that the small-molecule drug XJH05 is safe, effective, and free of adverse reactions; however, clinical data regarding XJH05 ointment in the treatment of patients with plaque psoriasis are still lacking. Therefore, we plan to conduct a prospective, interventional, exploratory study on the efficacy of XJH05 ointment in treating plaque psoriasis, hoping to provide further evidence regarding the therapeutic efficacy of XJH05 ointment in the psoriasis patient population.

Conditions

Psoriasis; Psoriasis (PsO)

Keywords

Randomization; Small molecule; Psoriasis

Outcome Measures

Primary Outcomes (2)

• Observation of the changes in the phenotypes of psoriasis lesions before and after treatment using dermoscopy

  From enrollment to the end of treatment at 4 weeks

• PGA score

  From enrollment to the end of treatment at 4 weeks

Secondary Outcomes (1)

• NRS itch score

  From enrollment to the end of treatment at 4 weeks

Study Arms (2)

XJH05 group

EXPERIMENTAL

Apply the small molecule compound XJH05 ointment twice daily and apply it for 4 weeks. Evenly apply the ointment on the affected area and massage it. Use the standard amount of approximately 500mg per fingertip, which covers about two palm areas. Take skin mirror photos of the patient's affected area at 0 and 4 weeks after enrollment for record. After 4 weeks of treatment, evaluate the improvement of the patient's PGA score and the itch NRS score.

Drug: XJH05 ointment

Calcipotriol group

EXPERIMENTAL

Apply the calcipotriol ointment twice daily and apply it for 4 weeks. Evenly apply the ointment on the affected area and massage it. Use the standard amount of approximately 500mg per fingertip, which covers about two palm areas. Take skin mirror photos of the patient's affected area at 0 and 4 weeks after enrollment for record. After 4 weeks of treatment, evaluate the improvement of the patient's PGA score and the itch NRS score.

Drug: Calcipotriol ointment

Interventions

XJH05 ointment DRUG

Apply the small molecule compound XJH05 ointment twice daily and apply it for 4 weeks. Evenly apply the ointment on the affected area and massage it. Use the standard amount of approximately 500mg per fingertip, which covers about two palm areas. Take skin mirror photos of the patient's affected area at 0 and 4 weeks after enrollment for record. After 4 weeks of treatment, evaluate the improvement of the patient's PGA score and the itch NRS score.

XJH05 group

Calcipotriol ointment DRUG

Apply the calcipotriol ointment twice daily and apply it for 4 weeks. Evenly apply the ointment on the affected area and massage it. Use the standard amount of approximately 500mg per fingertip, which covers about two palm areas. Take skin mirror photos of the patient's affected area at 0 and 4 weeks after enrollment for record. After 4 weeks of treatment, evaluate the improvement of the patient's PGA score and the itch NRS score.

Calcipotriol group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of plaque psoriasis.
• Mild-to-moderate disease presentation suitable for topical intervention (e.g., ≤2% to 10% BSA).
• Provision of written informed consent prior to study procedures.

You may not qualify if:

• Non-plaque subtypes (e.g., erythrodermic, pustular, or generalized guttate psoriasis).
• Recent use of systemic antipsoriatic therapies, biologics, or topical steroids/retinoids within the protocol-defined washout period.
• Active localized skin infection at target sites or known hypersensitivity to XJH05 or ointment ingredients.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Department of Dermatology, Xijing Hospital, Air Force Medical University

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Yunfeng Gu

CONTACT

17778914020; guyunfengzyx@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 24, 2026
• Study Start: November 17, 2025
• Primary Completion: August 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

CN (1)