A Study of HS-20137 in Participants with Moderate-to-severe Plaque Psoriasis

NCT06844799 | Not Yet Recruiting Phase 3

• 1 other identifier: HS-20137-301
• Study Type: interventional
• Target: 720
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study is to evaluate the efficacy and safety of HS-20137 in the treatment of participants with moderate to severe plaque psoriasis.

Conditions

Moderate-to-severe Plaque Psoriasis

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 90 Percent or Above

  Number of participants achieving greater than or equal to 90 percent improvement in PASI at Week 16. PASI is a widely used tool for the measurement of severity of psoriasis. AND, number of participants achieving a physician global assessment (PGA) (0 \[none\] to 4 \[severe\]) of cleared or minimal at Week 16

  At week 16

• Physician Global Assessment (PGA) score of 0/1

  number of participants achieving a physician global assessment (PGA) (0 \[none\] to 4 \[severe\]) of cleared or minimal at Week 16. The PGA is 5-point scale used in clinical trials of various diseases. In this the physician checks the state of the disease and gives them score from 0 (clear) to 4 (severe)

  At week 16

Secondary Outcomes (6)

• PASI 90 response rate at other visit time points

  up to 60 weeks

• PASI scores and changes from baseline at each visit time point

  up to 60 weeks

• PASI 75 response rate and PASI 100 response rate at each visit time point

  up to 60 weeks

• sPGA 0/1 response rate at other visit time points

  during the study period except 16 weeks

• sPGA 0 response rate at each visit time point

  up to 60 weeks

Study Arms (4)

HS-20137 arm1: HS-20137 200mg injection at week 0, 4, 8 and then every 8 weeks thereafter

EXPERIMENTAL

Drug: HS-20137

HS-20137 arm 2:HS-20137 200mg injection at week 0, 4, 8 and then every 12 weeks thereafter

EXPERIMENTAL

Drug: HS-20137

Placebo arm 1:Placebo at week 0,4,8, and HS-20137 200mg at week 16,20,24 and every8 week thereafter

EXPERIMENTAL

Drug: Placebo&HS-20137

Placebo arm 2:Placebo at week 0,4,8, and HS-20137 200mg at week 16,20,24 and every 12week thereafter

EXPERIMENTAL

Drug: Placebo&HS-20137

Interventions

HS-20137 DRUG

HS-20137 200mg injection at week 0, 4, 8 and then every 8 or 12 weeks.

HS-20137 arm 2:HS-20137 200mg injection at week 0, 4, 8 and then every 12 weeks thereafter; HS-20137 arm1: HS-20137 200mg injection at week 0, 4, 8 and then every 8 weeks thereafter

Placebo&HS-20137 DRUG

Placebo injection at week 0, 4, 8, and then HS-20137 200mg injection at week 16, 20, 24, and every 8 or 12 weeks thereafter

Placebo arm 1:Placebo at week 0,4,8, and HS-20137 200mg at week 16,20,24 and every8 week thereafter; Placebo arm 2:Placebo at week 0,4,8, and HS-20137 200mg at week 16,20,24 and every 12week thereafter

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 and above, male or female;
• Diagnosed plaque psoriasis for at least 6 months before randomization, with or without psoriatic arthritis;
• During screening and randomization, the severity of plaque psoriasis was moderate to severe, and the following conditions should be met: a) BSA≥10%; b) PASI≥12; c) sPGA≥3;
• Suitable for systemic therapy or phototherapy;
• Voluntarily participate in the research, have the ability and willingness to complete the research according to the research protocol, and sign the informed consent.

You may not qualify if:

• Previous use of biological agents, or allergic reactions to known drug ingredients, or previous severe food or drug allergies;
• Confirmation of other types of psoriasis, including but not limited to guttiform psoriasis, pustular psoriasis, erythrodermic psoriasis, drug-induced exacerbation of psoriasis (including beta-blockers, non-steroidal anti-inflammatory drugs, antimalarial drugs, interferon, calcium channel blockers, or lithium induced psoriasis) from the screening period to the time before randomization;
• Other skin lesions, chronic inflammatory diseases or autoimmune diseases, including but not limited to systemic lupus erythematosus, Sjogren's syndrome, skin sclerosis, etc., assessed by the investigator and other factors that may affect the efficacy evaluation or assessed by other researchers before randomization;
• Primary treatment failure occurred with previous use of similar investigatory drugs (including marketed ulinumab, gusecciumab, Tiricizumab, Lisenciumab, and IL-23 target investigatory drugs under development) (the minimum treatment standard was not reached 12 weeks after the first treatment);
• Use of the following drugs before randomization:
• Use of topical treatment drugs that affect the evaluation of psoriasis within 2 weeks before randomization;
• weeks before randomization, Use of phototherapy, traditional systemic therapy drugs, small molecule targeted drugs that may affect the evaluation of psoriasis;
• use of TNF-α biologics within 3 months prior to randomization;
• use of other biologics for the treatment of psoriasis within 6 months before randomization; e) Use of oral or topical proprietary Chinese medicinesor other Chinese herbal medicines that affect or may affect the evaluation of psoriasis within 4 weeks prior to randomization;
• f) use of lymphocyte migration regulators or B cell and T cell regulators within 3 months before randomization, or 6 months before screening, (whichever is older) use of B-cell-specific scavenging drugs;
• A history of chronic recurrent infection, or opportunistic infection in the 6 months prior to screening, or hospitalization for a serious infectious disease or intravenous antibiotic use in the 2 months prior to randomization, with a confirmed or suspected illness in the 1 week prior to randomization. And Other circumstances determined by the investigator to be unsuitable for further study participation.

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: February 7, 2025
• First Posted: February 25, 2025
• Study Start: June 10, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 25, 2025

Record last verified: 2025-02