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

Last updated: February 19, 2025
Sponsor: Hansoh BioMedical R&D Company
Overall Status: Active - Not Recruiting

Phase

3

Condition

Skin Wounds

Warts

Rash

Treatment

HS-20137

Placebo&HS-20137

Clinical Study ID

NCT06844799
HS-20137-301
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adults aged 18 and above, male or female;

  2. Diagnosed plaque psoriasis for at least 6 months before randomization, with orwithout psoriatic arthritis;

  3. During screening and randomization, the severity of plaque psoriasis was moderate tosevere, and the following conditions should be met: a) BSA≥10%; b) PASI≥12; c)sPGA≥3;

  4. Suitable for systemic therapy or phototherapy;

  5. Voluntarily participate in the research, have the ability and willingness tocomplete the research according to the research protocol, and sign the informedconsent.

Exclusion

Exclusion Criteria:

  1. Previous use of biological agents, or allergic reactions to known drug ingredients,or previous severe food or drug allergies;

  2. Confirmation of other types of psoriasis, including but not limited to guttiformpsoriasis, pustular psoriasis, erythrodermic psoriasis, drug-induced exacerbation ofpsoriasis (including beta-blockers, non-steroidal anti-inflammatory drugs,antimalarial drugs, interferon, calcium channel blockers, or lithium inducedpsoriasis) from the screening period to the time before randomization;

  3. Other skin lesions, chronic inflammatory diseases or autoimmune diseases, includingbut not limited to systemic lupus erythematosus, Sjogren's syndrome, skin sclerosis,etc., assessed by the investigator and other factors that may affect the efficacyevaluation or assessed by other researchers before randomization;

  4. Primary treatment failure occurred with previous use of similar investigatory drugs (including marketed ulinumab, gusecciumab, Tiricizumab, Lisenciumab, and IL-23target investigatory drugs under development) (the minimum treatment standard wasnot reached 12 weeks after the first treatment);

  5. Use of the following drugs before randomization:

  6. Use of topical treatment drugs that affect the evaluation of psoriasis within 2weeks before randomization;

  7. 4 weeks before randomization, Use of phototherapy, traditional systemic therapydrugs, small molecule targeted drugs that may affect the evaluation ofpsoriasis;

  8. use of TNF-α biologics within 3 months prior to randomization;

  9. use of other biologics for the treatment of psoriasis within 6 months beforerandomization; e) Use of oral or topical proprietary Chinese medicinesor otherChinese herbal medicines that affect or may affect the evaluation of psoriasiswithin 4 weeks prior to randomization; f) use of lymphocyte migration regulators or B cell and T cell regulators within 3months before randomization, or 6 months before screening, (whichever is older) useof B-cell-specific scavenging drugs;

  10. A history of chronic recurrent infection, or opportunistic infection in the 6 monthsprior to screening, or hospitalization for a serious infectious disease orintravenous antibiotic use in the 2 months prior to randomization, with a confirmedor suspected illness in the 1 week prior to randomization. And Other circumstancesdetermined by the investigator to be unsuitable for further study participation.

Study Design

Total Participants: 720
Treatment Group(s): 2
Primary Treatment: HS-20137
Phase: 3
Study Start date:
June 10, 2025
Estimated Completion Date:
June 30, 2027

Study Description

HS-20137 is an antibody targeting IL-23, which were recommended biologic agents for the treatment of patients with moderate-to-severe psoriasis. This is a randomized, double-blinded, placebo-controlled phase 3 study, including a 4 weeks screening period, a 52 weeks double-blinded period (placebo-control period in the first 16 weeks) and a 8 weeks follow-up period (total 60 weeks). The hypothesis is that HS-20137 will be more effective in treatment of psoriasis than placebo and well tolerated. Participants with moderate-to-severe plaque psoriasis will be included in this study and received HS-20137 200mg or placebo in week 0, 4, 8 in placebo-control period and then HS-20137 200mg every 8 or 12 weeks thereafter.