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Completed

NCT Number: NCT05863273

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)

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。

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

the First Hospital of China Medical University, Shenyang, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Apremilast

Drug

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

Primary outcomes

  1. DLQI or PASI improvement

    Time frame: 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 outcomes

  1. PASI, PGA, BSA, DLQI, pruritus VAS and pain VAS

    Time frame: 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

  2. DLQI improvement

    Time frame: 2 week

    Proportion of patients with DLQI score ≤5 or improvement ≥4 points from baseline at each visits

  3. DLQI improvement

    Time frame: 6 week

    Proportion of patients with DLQI score ≤5 or improvement ≥4 points from baseline at each visits

  4. DLQI improvement

    Time frame: 10 week

    Proportion of patients with DLQI score ≤5 or improvement ≥4 points from baseline at each visits

Sponsors and collaborators

Lead sponsor

First Hospital of China Medical University

Other

Collaborators

  • China-Japan Friendship Hospital

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 18, 2023
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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