PsoriasisNCT05863273
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）
An observational study of Psoriasis, run by First Hospital of China Medical University at 2 sites in China.
Trial 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。 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Apremilast
- How many people
- 360 participants
- Where
- 2 sitesChina
- Study dates
- 22 May 2023to 10 Mar 2025
- Phase
- Observational
- 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
Study population: Chinese patients with moderate to severe plaque psoriasis
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
China-Japan Friendship Hospital
Beijing
the First Hospital of China Medical University
Shenyang, China, 110001
About this study
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。
- Conditions
- Psoriasis
- Being tested
- Apremilast
- Keywords
- Apremilast, Otazla, Real World Study
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApremilastDrug
Dosage of Apremilast（Otezla®） from 10mg qd, titrate to recommended dosage of 30 mg BID，recommended by specification.
| Study group | Role | What they receive |
|---|---|---|
| Apremilast | Dosage of Apremilast（Otezla®） from 10mg qd, titrate to recommended dosage of 30 mg BID，recommended by specification. Receives: Drug: Apremilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLQI or PASI improvement
At week 16，Proportion of patients with DLQI improvement (DLQI ≤5 or DLQI improvement by ≥4 points from baseline) or PASI improvement (PASI <3)
Measured: 16 week
Secondary outcomes (4)
PASI, PGA, BSA, DLQI, pruritus VAS and pain VAS
Absolute values of change from baseline in PASI, PGA, BSA, DLQI, pruritus VAS and pain VAS in subjects at week 16 of treatment
Measured: 16 week
DLQI improvement
Proportion of patients with DLQI score ≤5 or improvement ≥4 points from baseline at each visits
Measured: 2 week
DLQI improvement
Proportion of patients with DLQI score ≤5 or improvement ≥4 points from baseline at each visits
Measured: 6 week
DLQI improvement
Proportion of patients with DLQI score ≤5 or improvement ≥4 points from baseline at each visits
Measured: 10 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start22 May 2023
- Primary completion10 Feb 2025
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- China-Japan Friendship Hospital
- Responsible party
- Principal investigator, Xing hua Gao, First Hospital of China Medical University
- Investigators
- Xinghua Gao, MD, Study director, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863273
- Sponsor's protocol ID
- OTL-A-2201
- Status last verified
- Mar 2025
- First submitted
- 9 May 2023
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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）
- ClinicalTrials.gov ID
- NCT05863273
- Acronym / sponsor ID
- OTL-A-2201
- Conditions
- Psoriasis
- Keywords
- Apremilast, Otazla, Real World Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Collaborators
- China-Japan Friendship Hospital
- Study start
- 22 May 2023 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 18 May 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.
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。
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apremilast | – | Drug: ApremilastDosage of Apremilast（Otezla®） from 10mg qd, titrate to recommended dosage of 30 mg BID，recommended by specification. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese patients with moderate to severe plaque psoriasis
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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；
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 |
|---|---|---|
| ApremilastDosage of Apremilast（Otezla®） from 10mg qd, titrate to recommended dosage of 30 mg BID，recommended by specification. | Drug | Apremilast |
Primary outcome
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)
4 secondary outcomes
PASI, PGA, BSA, DLQI, pruritus VAS and pain VAS
Time frame: 16 week
DLQI improvement
Time frame: 2 week
DLQI improvement
Time frame: 6 week
DLQI improvement
Time frame: 10 week
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 17 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Xinghua Gao, MD study director
First Hospital of China Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by First Hospital of China Medical University at 2 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 4 inclusion and 7 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 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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?
DLQI or PASI improvement (time frame: 16 week). 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 17 Mar 2025.