Real World Study on the Efficacy and Safety of Apremilast in Chinese Patients with Moderate to Severe Plaque Psoriasis, a Multi Center, Prospective, Observational Trial（REACT）

Completed

• Conditions: Psoriasis
• Interventions: Drug: Apremilast

• Registration Number: NCT05863273
• Lead Sponsor: First Hospital of China Medical University

Brief Summary

This is a multicenter, one-arm, prospective, observational study，intended to assess evaluation of efficacy and safety of Apremilast in Chinese patients with moderate-to-severe plaque psoriasis。During this study, it is expected to collect data at at baseline and weeks 2, 6, 10, 16, and 20 after treatment。

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-09
• Study First Submitted QC: 2023-05-09
• Study First Posted: 2023-05-18
• Study Start: 2023-05-22
• Primary Completion: 2025-02-10
• Status Verified: 2025-03
• Study Completion: 2025-03-10
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Males or females, ≥ 18 years of age at the time of signing the informed consent document；
• Patients with moderate-to-severe plaque psoriasis：Simultaneously meet (1)and (2): (1)PASI≥ 3；(2) DLQI ≥ 6；
• Subject is a candidate for phototherapy and/or systemic therapy
• Patients who wish to be treated with Apremilast and sign the informed consent

Exclusion Criteria

• Allergy to Apremilast or any component of the study drug；
• Use of phototherapy within 4 weeks prior to randomization；Use of systemic drugs or biologic agents within 4 half-life periods prior to randomization；Patients with inadequate response or intolerance to previous systemic therapy do not need to consider drug washout；
• Currently using potent cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin, etc.)；
• History of substance abuse, suicide attempts, or mental illness；
• Patients who are currently pregnant, breastfeeding, or planning a pregnancy during the study observation period；
• Pustular type, erythroderma type and other psoriasis patients；
• Other circumstances that investigators don't consider appropriate to include.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Apremilast	Apremilast	Dosage of Apremilast（Otezla®） from 10mg qd, titrate to recommended dosage of 30 mg BID，recommended by specification.

Primary Outcome Measures

Name	Time	Method
DLQI or PASI improvement	16 week	At week 16，Proportion of patients with DLQI improvement (DLQI ≤5 or DLQI improvement by ≥4 points from baseline) or PASI improvement (PASI \<3)

Secondary Outcome Measures

Name	Time	Method
PASI, PGA, BSA, DLQI, pruritus VAS and pain VAS	16 week	Absolute values of change from baseline in PASI, PGA, BSA, DLQI, pruritus VAS and pain VAS in subjects at week 16 of treatment
DLQI improvement	10 week	Proportion of patients with DLQI score ≤5 or improvement ≥4 points from baseline at each visits

Trial Locations

Locations (2)

China-Japan Friendship Hospital; 🇨🇳 Beijing, China

the First Hospital of China Medical University; 🇨🇳 Shenyang, China