An Open-label Study of HS-20137 in Participants With Moderate-to-Severe Plaque Psoriasis

An Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of HS-20137, an Anti-IL-23 Monoclonal Antibody, in Participants With Moderate-to-severe Plaque Psoriasis

HS-20137 is an antibody targeting interleukin-23 (IL-23), a key cytokine involved in the pathogenesis of psoriasis. IL-23-targeting biologic agents are recommended for the treatment of patients with moderate-to-severe psoriasis. This is an open-label, Phase 2, single-arm interventional study, including a 4-week screening period, a 16-week treatment period and a 4-week follow-up period (total 24 weeks). Participants with moderate-to-severe plaque psoriasis will be enrolled in this study and will receive HS-20137 200 mg at weeks 0, 4 and 8. The primary objective is to evaluate the safety and tolerability of HS-20137. Secondary objectives are to evaluate the efficacy and immunogenicity of HS-20137

Inclusion Criteria:

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

Exclusion Criteria:

1. History of an allergic reaction following prior use of a biologic agent, allergy to known drug components, or a history of severe food or drug allergy;
2. 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 the first dose;
3. 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 the first dose;
4. 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);
5. Use of the following drugs before the first dose:

1. Use of topical treatment drugs that affect the evaluation of psoriasis within 2 weeks before the first dose;
2. 1 weeks before the first administration, Use of phototherapy, traditional systemic therapy drugs, small molecule targeted drugs that may affect the evaluation of psoriasis;
3. Prior to the first dose, use of other biologics for the treatment of psoriasis (including but not limited to TNF α inhibitors, secukinumab, ixekizumab, ustekinumab, guselkumab, tildrakizumab, risankizumab, and investigational IL 23 targeting drugs) without meeting the protocol required time interval for re administration of the original biologic;
4. use of lymphocyte migration regulators or B cell and T cell regulators (including but not limited to abatacept, telitacicept, etc.), within 3 months before dose, or 6 months before screening, (whichever is older) use of B-cell-specific scavenging drugs (including but not limited to rituximab, inebilizumab, etc.);
6. 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 the first dose. And Other circumstances determined by the investigator to be unsuitable for further study participation.

HS-20137 200 mg injection at weeks 0, 4 and 8

Participants receive HS-20137 by subcutaneous injection at weeks 0, 4 and 8