A Phase 2 Study of HS-20118 to Evaluate the Efficacy and Safety in Participant With Moderate-to-Severe Plaque Psoriasis

NCT07765628 | Not Yet Recruiting Phase 2

• 1 other identifier: HS-20118-201
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study is to evaluate the efficacy of HS-20118 compared with placebo in participants with moderate to severe plaque psoriasis.

Conditions

Moderate to Severe Plaque Psoriasis

Keywords

Plaque psoriasis

Outcome Measures

Primary Outcomes (1)

• Proportion of participants achieving PASI 75 (≥75% improvement from baseline in PASI) at Week 16

  Percentage of participants achieving PASI 75 response (\>=75% improvement in PASI from baseline) at Week 16 will be reported. The PASI is a system for assessing/grading psoriatic lesion severity and treatment response. It divides the body into 4 regions (head, trunk, upper extremities, lower extremities), with each region separately scored for erythema, induration, scaling (0-4 scale each) and involvement extent (0-6 scale). PASI yields a 0-72 numeric score, where higher scores mean more severe disease.

  16 weeks

Study Arms (3)

HS-20118 dose 1

EXPERIMENTAL

Drug: HS-20118

HS-20118 dose 2

EXPERIMENTAL

Drug: HS-20118

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HS-20118 DRUG

Administered orally, once weekly (QW)

HS-20118 dose 1; HS-20118 dose 2

Placebo DRUG

Administered orally, once weekly (QW)

Placebo

Eligibility Criteria

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

You may qualify if:

• Participants voluntarily agree to comply with all study procedures and scheduled follow-up assessments, and to cooperate with the collection of lesion photographs and other protocol-specified requirements;
• Diagnosis of plaque psoriasis, with or without PsA, established for at least 26 weeks prior to the first administration of study intervention. If previously diagnosed with psoriasis, participants must have a documented history of psoriasis for at least 26 weeks and must be confirmed by the investigator during screening to have plaque psoriasis;
• At screening and baseline, participants must be confirmed by the investigator to have stable moderate-to-severe plaque psoriasis, as defined by meeting all of the following four criteria:
• \) No morphological changes or significant disease flares during the 4 weeks preceding screening, as assessed by the investigator; 2) BSA≥10%； 3) PASI≥12； 4) IGA≥3； 4. Be a candidate for phototherapy or systemic treatment for plaque psoriasis; 5. Participants must have no plans for pregnancy or sperm/egg donation during the study period. If of childbearing age, women must not be pregnant or breastfeeding, and must have a negative blood pregnancy test within 7 days before randomization. Participants and their partners must voluntarily use highly effective contraception during the study period and for at least 3 months after the last dose.

You may not qualify if:

• Known allergy, hypersensitivity, or intolerance to biologics, study drugs, or their excipients.
• Non-plaque psoriasis (e.g., guttate, erythrodermic, pustular, or drug-induced psoriasis) at screening or randomization.
• Other skin lesions or systemic autoimmune diseases (e.g., systemic lupus erythematosus, Sjögren's syndrome, scleroderma) that may affect the safety and efficacy assessment of the study drug.
• Other skin lesions or systemic autoimmune diseases (e.g., systemic lupus erythematosus, Sjögren's syndrome, scleroderma) that may affect the safety and efficacy assessment of the study drug.
• Severe, progressive, or poorly controlled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, hematologic, rheumatologic, psychiatric, or metabolic disorders; or current signs or symptoms related to these conditions.
• History of malignancy within 5 years before screening (except for adequately treated skin basal cell carcinoma, in situ skin cancer, or in situ cervical cancer with no recurrence for at least 12 weeks before the first dose).
• History of lymphoproliferative disorders (e.g., lymphoma), unexplained monoclonal gammopathy, or signs and symptoms suggestive of lymphoproliferative disorders (e.g., splenomegaly or severe lymphadenopathy).
• Any other condition deemed by the investigator as unsuitable for participation in the clinical study.

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Central Study Contacts

Yong Cui

CONTACT

15701625913; Wuhucuiyong@vip.163.com

Liming Wu

CONTACT

18957118053@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 14, 2026
• Study Start: August 6, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): July 10, 2027
• Last Updated: August 14, 2026

Record last verified: 2026-08