Moderate-to-severe Plaque Psoriasis study: HS-20137
Official title An Open-label Study of HS-20137 in Participants With Moderate-to-Severe Plaque Psoriasis
ClinicalTrials.gov ID: NCT07879885
What this study is testing
What is HS-20137?
This is an investigational injectable medicine being studied for moderate-to-severe plaque psoriasis. It is designed to block a protein called interleukin-23 (IL-23) that helps drive the skin inflammation seen in psoriasis.
Also referred to as QX004N.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if HS‑20137 is safe and works for treating moderate‑to‑severe plaque psoriasis.
- Who it's for
- Adults who have moderate‑to‑severe plaque psoriasis.
- What's involved
- Participants will receive HS‑20137 and may have visits and tests to monitor safety and effectiveness.
- Time commitment
- The study lasts several weeks to months, with scheduled clinic visits and monitoring appointments.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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≥3%
- Voluntarily participate in the research, have the ability and willingness to complete the research according to the research protocol, and sign the...
You likely can't join if
- 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...
- Confirmation of other types of psoriasis, including but not limited to guttiform psoriasis, pustular psoriasis, erythrodermic psoriasis, drug-induced...
- Other skin lesions, chronic inflammatory diseases or autoimmune diseases, including but not limited to systemic lupus erythematosus, Sjogren's...
- Primary treatment failure occurred with previous use of similar investigatory drugs (including marketed ulinumab, gusecciumab, Tiricizumab...
- Use of topical treatment drugs that affect the evaluation of psoriasis within 2 weeks before the first dose;
- 1 weeks before the first administration, Use of phototherapy, traditional systemic therapy drugs, small molecule targeted drugs that may affect the...
See the full eligibility criteria
- 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≥3%; b) PASI≥3;
- Voluntarily participate in the research, have the ability and willingness to complete the research according to the research protocol, and sign the informed consent.
- 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;
- 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...
- 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...
- 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...
- Use of topical treatment drugs that affect the evaluation of psoriasis within 2 weeks before the first dose;
- 1 weeks before the first administration, Use of phototherapy, traditional systemic therapy drugs, small molecule targeted drugs that may affect the evaluation of psoriasis;
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Beijing, Beijng, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Beijing, Beijng, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.