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Completed

NCT Number: NCT06122649

A Study to Investigate Efficacy and Safety of Apremilast 30 mg Twice Daily (BID) in Chinese Participants With Moderate to Severe Plaque-type Psoriasis (PsO)

The study aims to evaluate the clinical efficacy of oral apremilast 30 mg BID compared with placebo in Chinese participants with moderate to severe PsO

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Key information

Conditions

Plaque Psoriasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University First Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chinese participants aged ≥18.
  • Diagnosis of chronic, stable moderate to severe plaque PsO for ≥ 12 months before screening. The participant must have sPGA score ≥ 3, PASI score ≥ 12, and BSA involvement ≥ 10% at both screening and baseline (week 0).
  • Participant is a candidate for phototherapy and/or systemic therapy. Exclusion Criteria
  • Psoriasis flare within 4 weeks of screening.
  • Evidence of skin conditions that would interfere with evaluations of the effect of study medication on psoriasis.
  • Prior medical history of suicide attempt at any time in the participant's lifetime before screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years.
  • Participant has a malignancy or history of malignancy or myeloproliferative or lymphoproliferative disease within the past 3 years.
  • Active tuberculosis or a history of incompletely treated tuberculosis.
  • History of human immunodeficiency virus (HIV) infection.
  • Prior treatment with apremilast.
  • Female participants of childbearing potential unwilling to use protocol specified method of contraception.
  • Female participants who are breastfeeding or who plan to breastfeed.
  • Female participants planning to become pregnant.

Treatment and study plan

Apremilast

Drug

Oral tablet

Other names: Otezla®

Placebo

Drug

Oral tablet

Primary outcomes

  1. Number of Participants Achieving at least a 75% Reduction (Improvement) From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16

    Time frame: Week 16

Secondary outcomes

  1. Number of Participants Achieving a Static Physician's Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) and with ≥ 2-point Reduction From Baseline at Week 16

    Time frame: Baseline and Week 16

  2. Number of Participants Achieving ≥ 4-point Reduction (Improvement) From Baseline in the Whole Body Itch Scale (NRS) Score at Week 16

    Time frame: Baseline and Week 16

  3. Number of Participants with Baseline Scalp Physician's Globa Assesment (ScPGA) of ≥ 2 Achieving a Clear (0) or Almost Clear (1) ScPGA and with ≥ 2-point Reduction From Baseline and at Week 16

    Time frame: Baseline and Week 16

  4. Percent Change of PASI From Baseline at Week 16

    Time frame: Baseline and Week 16

  5. Percent Change From Baseline in Affected Body Surface Area (BSA) at Week 16

    Time frame: Baseline and Week 16

  6. Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16

    Time frame: Baseline and Week 16

  7. Number of Participants who Have a Baseline Scalp Itch NRS ≥ 4 and Achieving ≥ 4-point Reduction (Improvement) From Baseline in Scalp Itch NRS at Week 16

    Time frame: Baseline and Week 16

  8. Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

    Time frame: Baseline to Week 52

    TEAEs are any event that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs.

  9. Plasma Concentration of Apremilast

    Time frame: Baseline to Week 16

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of Apremilast 30 mg Twice Daily in Chinese Subjects With Moderate to Severe Plaque-type Psoriasis

Acronym: ESSENCE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 8, 2023
Registry last updated
Jan 5, 2026

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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