Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ICP-488 in Patients With Moderate to Severe Plaque Psoriasis

Moderate to Severe Plaque Psoriasis Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of ICP-488 in Patients With Moderate to Severe Plaque Psoriasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06109818
• Other study ID #: ICP-CL-01002
• Status: Recruiting
• Phase: Phase 2
• Start date: January 4, 2024
• Est. completion date: November 5, 2024

Study information

• Verified date: February 2024
• Source: Beijing InnoCare Pharma Tech Co., Ltd.
• Contact: Alexia Lu
• Phone: 010-66609745
• Email: CO_HGRAC[@]innocarepharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate ICP-488.Efficacy, safety, PK, and PD characteristics in Chinese adults with moderate to severe plaque psoriasis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 129
• Est. completion date: November 5, 2024
• Est. primary completion date: October 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Subjects voluntarily participate in this study and have signed informed consent.

2. Male or female subjects between the ages of 18 and 70 (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. Presence of infection or immune-related disease.

3. Subjects with a history of TB or at risk for TB.

4. Received related treatment within the time window specified in the protocol.

5. An interval of less than 5 half-lives or 28 days (if any available halflife data) from the last dose of a strong CYP1A2 inhibitor or inducer, or a plan to use concurrently medications, dietary supplements or food with strong CYP1A2 inhibitory or inductive effect during study participation.

6. 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.

7. Pregnant or lactating women, or women who plan to become pregnant during study participation.

8. A history of severe drug allergies.

9. Any other conditions in which the investigator considers it unsuitable for the subject to participate in this study.

Related Conditions & MeSH terms

• Moderate to Severe Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• ICP-488 Tablets
ICP-488 will be administered as tablet
• ICP-488 Placebo
ICP-488 Placebo will be administered as tablet

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing	Beijing
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	First Hospital of Jilin University	Changchun	Jilin
China	The third xinagya hospital of central south unversity	Changsha	Hunan
China	Xiangya hospital central south university	Changsha	Hunan
China	Changzhou First People's Hospital	Changzhou	Jiangsu
China	The Affiliated Hospital of Chengde Medical College	Chengde	Hebei
China	Chengdu Second People's Hospital	Chengdu	Sichuan
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	Dermatology Hospital of Southern Medical University	Guangzhou	Guangdong
China	Guangdong Hospital of Traditional Chinese Medicine	Guangzhou	Guangdong
China	Affiliated Hospital of Guizhou Medical University	Guiyang	Guizhou
China	Hangzhou First People's Hospital	Hangzhou	Zhejiang
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	Affiliated Hospital of Inner Mongolia Medical University	Hohhot	Inner Mongolia Autonomous Region
China	The First Hospital of Jiaxing	Jiaxing	Zhejiang
China	Central Hospital affiliated to shandong first medical unversity	Jinan	Shandong
China	The First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	Lianyungang First People's Hospital	Lianyungang	Jiangsu
China	Mei he kou central hospital	Meihekou	Jilin
China	Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of medical Sciences, Peking Union Medical College	Nanjing	Jiangsu
China	Nanyang city first People's Hospital	Nanyang	Henan
China	Huashan Hospital Affiliated to Fudan University	Shanghai	Shanghai
China	Shanghai Dermatology Hospital	Shanghai	Shanghai
China	General Hospital of Northeast International Hospital	Shenyang	Liaoning
China	The first hospital of hebei medical university	Shijia Zhuang	Hebei
China	The Second Affiliated Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Shiyan City People's Hospital	Shiyan	Hubei
China	Second hospital of shaxi medical unversity	Taiyuan	Shanxi
China	Tianjin Academy of Traditional Chinese Medicine affiliated Hospital	Tianjin	Tianjin
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Wuhan No.1 hospital	Wuhan	Hubei
China	Wuhan University People's Hospital	Wuhan	Hubei
China	The Second affiliated hospital of Xian jiaotong Unversity	Xi'an	Shanxi
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Beijing InnoCare Pharma Tech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects who achieved a PASI 75 response (a reduction of minimum 75% from baseline in PASI score) at Week 12.	Proportion of subjects who achieved PASI 75 (PASI score improvement of at least 75% from baseline) at week 12.	Baseline up to Week 12