HS-20137: a treatment option for adults with moderate-to-severe plaque psoriasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, open-label phase 2 trial to evaluate HS-20137, an IL-23–targeting antibody, in adults with moderate-to-severe plaque psoriasis. Participants undergo a 4-week screening, 16 weeks of treatment, and 4 weeks of follow-up (total 24 weeks). The primary goal is safety and tolerability, with secondary assessments of efficacy and immunogenicity. The study consists of three planned dosing visits and monitoring for adverse events and psoriasis severity. Location is China, at the China-Japan Friendship Hospital in Beijing, sponsored by Hansoh BioMedical R&D Company.

Why it matters

Who can join: the full rules

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.

Where it's running

• China-Japan Friendship Hospital
  Beijing, Beijng, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.