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Tests treatment safety and results for Plaque Psoriasis Patients
Official title Efficacy, Safety, Pharmacokinetics of ICP-488 in Patients With Moderate to Severe Plaque Psoriasis
ClinicalTrials.gov ID: NCT06842199
What this study is testing
What is ICP-488 Tablets?
ICP-488 Tablets is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for plaque psoriasis patients.
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
- This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy, safety, PK characteristics of ICP-488 in Chinese adults with moderate to severe plaque psoriasis.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Eligible people must meet all of the following criteria:
- people voluntarily participate in this study and have signed informed consent.
- Male or female people between the ages of 18 and 75 (including the threshold) at the time of signing the ICF.
- History of plaque psoriasis ≥6 months at baseline.
- people need to receive systemic therapy and/or phototherapy.
You likely can't join if
- The diagnosis was non-plaque psoriasis.
- people with concurrent skin diseases that the investigator believes would interfere with the study assessments.
- Presence of infection or immune-related disease.
- people with a history of TB or at risk for TB.
- Received related treatment within the time window specified in the protocol.
- An interval of less than 5 half-lives or 28 days (if any available half-life data) from the last dose of a strong CYP1A2/CYP3A4 inhibitor or inducer...
See the full eligibility criteria
- Eligible people must meet all of the following criteria:
- people voluntarily participate in this study and have signed informed consent.
- Male or female people between the ages of 18 and 75 (including the threshold) at the time of signing the ICF.
- History of plaque psoriasis ≥6 months at baseline.
- people need to receive systemic therapy and/or phototherapy.
- The following three criteria were met: a) psoriasis Area and Severity index (PASI) score ≥12; b) Psoriasis affected body surface area (BSA) ≥10%; c) Static physician overall assessment (sPGA) ≥3 scores
- The diagnosis was non-plaque psoriasis.
- people with concurrent skin diseases that the investigator believes would interfere with the study assessments.
- Presence of infection or immune-related disease.
- people with a history of TB or at risk for TB.
- Received related treatment within the time window specified in the protocol.
- An interval of less than 5 half-lives or 28 days (if any available half-life data) from the last dose of a strong CYP1A2/CYP3A4 inhibitor or inducer, or a plan to use concurrently medications with strong CYP1A2/CYP3A4...
- The investigator has determined that there are clinically significant test results and that participation in this trial would pose an unacceptable risk to patients; Or the laboratory values of the people in the...
- Pregnant or lactating women, or women who plan to become pregnant during study participation.
- A history of severe drug allergies.
- Any other conditions in which the investigator considers it unsuitable for the subject to participate in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Wuhu, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Liuzhou, Guangxi, China
- Guiyang, Guizhou, China
- Chengde, Hebei, China
- Shijiazhuang, Hebei, China
- Harbin, Heilongjiang, China
- Luoyang, Henan, China
- Nanyang, Henan, China
- Sanmenxia, Henan, China
- Zhengzhou, Henan, China
- Jingzhou, Hubei, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Changzhou, Jiangsu, China
- Lianyungang, Jiangsu, China
+ 16 more site(s).
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 - 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Wuhu, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Fuzhou, Fujian, China; Guangzhou, Guangdong, China and 30 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.