Plaque PsoriasisPhase 3ESSENCENCT06122649
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)
A Phase 3 study testing apremilast in people with Plaque Psoriasis, run by Amgen at 21 sites in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- apremilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 203 participants
- Where
- 21 sitesChina
- Study dates
- 27 Nov 2023to 5 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
None listed.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
China21 sites
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130021
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Chengdu Second Peoples Hospital
Chengdu, Sichuan, 610017
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Sichuan, 400010
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350000
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, 510091
Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
Shandong Provincial Hospital For Skin Diseases,Shandong First Medical University
Jinan, Shandong, 830001
Dermatology Hospital of Jiangxi Province
Nanchang, Jiangxi, 330000
Nanyang First Peoples Hospital
Nanyang, Henan, 473002
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, 200443
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Changshu No2 Peoples Hospital
Suzhou, Jiangsu, 215006
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Peoples Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830001
Wuxi Peoples Hospital
Wuxi, Jiangsu, 241023
Yichang Central Peoples Hospital
Yichang, Hubei, 443003
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750003
About this study
Official 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
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
- Conditions
- Plaque Psoriasis
- Being tested
- apremilast, Placebo
- Keywords
- Apremilast, Dermatology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apremilastDrug
Also called Otezla®
Oral tablet
PlaceboDrug
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Placebo-controlled Treatment Phas | Experimental | Participants are randomized in a 1:1 ratio to take either apremilast or placebo BID for 16 weeks. Receives: Drug: apremilast; Drug: Placebo |
| Active Treatment Phase | Experimental | Participants who received placebo during the placebo-controlled treatment phase will receive apremilast BID for 36 weeks. Participants who took apremilast will continue receiving it BID for 36 weeks. Receives: Drug: apremilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Achieving at least a 75% Reduction (Improvement) From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16
Measured: Week 16
Secondary outcomes (9)
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
Measured: Baseline and Week 16
Number of Participants Achieving ≥ 4-point Reduction (Improvement) From Baseline in the Whole Body Itch Scale (NRS) Score at Week 16
Measured: Baseline and Week 16
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
Measured: Baseline and Week 16
Percent Change of PASI From Baseline at Week 16
Measured: Baseline and Week 16
Percent Change From Baseline in Affected Body Surface Area (BSA) at Week 16
Measured: Baseline and Week 16
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16
Measured: Baseline and Week 16
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
Measured: Baseline and Week 16
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
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.
Measured: Baseline to Week 52
Plasma Concentration of Apremilast
Measured: Baseline to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start27 Nov 2023
- Primary completion28 Feb 2025
- Study completion5 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122649
- Sponsor's protocol ID
- 20200250
- Acronym
- ESSENCE
- Status last verified
- Dec 2025
- First submitted
- 3 Nov 2023
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06122649
- Acronym / sponsor ID
- ESSENCE / 20200250
- Conditions
- Plaque Psoriasis
- Keywords
- Apremilast, Dermatology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 5 Dec 2025 (actual)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo-controlled Treatment Phas | Experimental | Drug: apremilast, Drug: PlaceboParticipants are randomized in a 1:1 ratio to take either apremilast or placebo BID for 16 weeks. |
| Active Treatment Phase | Experimental | Drug: apremilastParticipants who received placebo during the placebo-controlled treatment phase will receive apremilast BID for 36 weeks. Participants who took apremilast will continue receiving it BID for 36 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| apremilastAlso: Otezla®Oral tablet | Drug | Active Treatment Phase, Placebo-controlled Treatment Phas |
| PlaceboOral tablet | Drug | Placebo-controlled Treatment Phas |
Primary outcome
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
9 secondary outcomes
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
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
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
Percent Change of PASI From Baseline at Week 16
Time frame: Baseline and Week 16
Percent Change From Baseline in Affected Body Surface Area (BSA) at Week 16
Time frame: Baseline and Week 16
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16
Time frame: Baseline and Week 16
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
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline to Week 52
Plasma Concentration of Apremilast
Time frame: Baseline to Week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing apremilast in people with Plaque Psoriasis, run by Amgen at 21 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.