RECRUITINGPhase 3INTERVENTIONAL
Efficacy, Safety, Pharmacokinetics of ICP-488 in Patients With Moderate to Severe Plaque Psoriasis
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Oral ICP-488 in Patients With Moderate to Severe Plaque Psoriasis
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
Eligible subjects must meet all of the following criteria:
1. Subjects voluntarily participate in this study and have signed willing to sign a consent form.
2. Male or female subjects between the ages of 18 and 75 (including the threshold) at the time of signing the ICF.
3. History of plaque psoriasis ≥6 months at baseline.
4. Subjects need to receive systemic therapy and/or phototherapy.
5. 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
Who Should NOT Join This Trial:
1. The diagnosis was non-plaque psoriasis.
2. Subjects with concurrent skin diseases that the investigator believes would interfere with the study assessments.
3. Presence of infection or immune-related disease.
4. Subjects with a history of TB or at risk for TB.
5. Received related treatment within the time window specified in the protocol.
6. 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 inhibitory or inductive effect during study participation.
7. 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 subjects in the screening period meet the criteria specified in the protocol.
8. Pregnant or lactating women, or women who plan to become pregnant during study participation.
9. A history of severe drug allergies.
10. Any other conditions in which the investigator considers it unsuitable for the subject to participate in this study.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
Eligible subjects must meet all of the following criteria:
1. Subjects voluntarily participate in this study and have signed informed consent.
2. Male or female subjects between the ages of 18 and 75 (including the threshold) at the time of signing the ICF.
3. History of plaque psoriasis ≥6 months at baseline.
4. Subjects need to receive systemic therapy and/or phototherapy.
5. 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
Exclusion Criteria:
1. The diagnosis was non-plaque psoriasis.
2. Subjects with concurrent skin diseases that the investigator believes would interfere with the study assessments.
3. Presence of infection or immune-related disease.
4. Subjects with a history of TB or at risk for TB.
5. Received related treatment within the time window specified in the protocol.
6. 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 inhibitory or inductive effect during study participation.
7. 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 subjects in the screening period meet the criteria specified in the protocol.
8. Pregnant or lactating women, or women who plan to become pregnant during study participation.
9. A history of severe drug allergies.
10. Any other conditions in which the investigator considers it unsuitable for the subject to participate in this study.
Treatments Being Tested
DRUG
ICP-488 Tablets
Eligible patients will receive ICP-488 orally as per the protocol
DRUG
ICP-488 Placebo
Eligible patients will receive ICP-488 Placebo orally as per the protocol
Locations (20)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The Second Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Beijing Chao-Yang Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Beijing Tongren Hospital,CMU
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Liuzhou People's Hospital
Liuchow, Guangxi, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Affiliated Hospital of Chengde Medical University
Chengde, Hebei, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The Second Affiliated Hospital of Henan University of Science and technology
Luoyang, Henan, China
Nanyang Central Hospital
Nanyang, Henan, China
Sanmenxia Central Hospital
Sanmenxia, Henan, China