Plaque PsoriasisPhase 4NCT02412644
Apremilast 30mg Bid With Narrowband UVB in the Treatment of Plaque Psoriasis
A Phase 4 study testing apremilast in people with Plaque Psoriasis, run by Psoriasis Treatment Center of Central New Jersey at 1 site in United States.
Trial summary
12 weeks open label with Otezla® and NUVB, followed by 6 month double blind Otezla® (apremilast) or placebo to subjects who obtain PASI 75 at week 12 of phototherapy 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2015to Jul 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
None listed.
Who cannot join
- Subjects who meet any of the following criteria will be excluded from participation in this study:
- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and/or guttate psoriasis) or drug induced psoriasis
- Subjects with previous exposure to apremilast
- Malignancy or history of malignancy, except for:
- treated [ie, cured] basal cell or squamous cell in situ skin carcinomas;
- treated [ie, cured] malignancy with no evidence of recurrence within the previous 5 years.
Trial locations and contacts
1 site in 1 country.
United States1 site
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520
About this study
Official title: Efficacy and Safety of Combining Apremilast 30mg Bid With Narrowband UVB in the Treatment of Moderate-to-severe Plaque Psoriasis
12 weeks open label with Otezla® and NUVB, followed by 6 month double blind Otezla® (apremilast) or placebo to subjects who obtain PASI 75 at week 12 of phototherapy
Read the detailed description
Primary Objective: To evaluate the effectiveness of Otezla (apremilast®) in promoting maintenance of response in those subjects who obtained PASI-75 at week 12 of phototherapy.
- Conditions
- Plaque Psoriasis
- Being tested
- apremilast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apremilastDrug
| Study group | Role | What they receive |
|---|---|---|
| Apremilast + apremilast | Active comparator | apremilast 30mg bid for 12 weeks.followed by apremilast 30 mg bid for 24 weeks Receives: Drug: apremilast |
| apremilast + placebo | Placebo comparator | apremilast 30mg bid for 12 weeks followed by placebo bid for 24 weeks Receives: Drug: apremilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Maintaining Psoriasis Area Severity Index Score (PASI) 75 at Week 36
Analysis of Psoriasis Area Severity Index Score at week 36 to determine number of subjects who maintained PASI 75 at week 36
Measured: 36weeks
Secondary outcomes (3)
Number of Subjects Achieving Psoriasis Area Severity Index Score (PASI) 75 Response at Week 12
Psoriasis Area Severity Score of 75 or greater at week 12
Measured: 12WEEKS
Number of Subjects Achieving Psoriasis Area Severity Index Score 90 at Week 36
PASI 90 or greater at week 36
Measured: 36 weeks
Number of Subjects Achieving Physician Global Assessment Score of 0 or 1 at Week 36
PGA score 0 or 1
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study start28 May 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Plaque 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Psoriasis Treatment Center of Central New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene
- Responsible party
- Sponsor
- Investigators
- Jerry Bagel, MD, Principal investigator, Psoriasis Treatment Center of Central New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412644
- Sponsor's protocol ID
- AP-CL-PSOR-PI-004893
- Status last verified
- Dec 2018
- First submitted
- 23 Feb 2015
- Last updated
- 28 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Combining Apremilast 30mg Bid With Narrowband UVB in the Treatment of Moderate-to-severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT02412644
- Acronym / sponsor ID
- AP-CL-PSOR-PI-004893
- Conditions
- Plaque Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Psoriasis Treatment Center of Central New JerseyUniversity, hospital or other
- Collaborators
- Celgene
- Study start
- 28 May 2015 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 9 Apr 2015 (estimated)
- Results
- Posted 28 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
12 weeks open label with Otezla® and NUVB, followed by 6 month double blind Otezla® (apremilast) or placebo to subjects who obtain PASI 75 at week 12 of phototherapy
Detailed description
Primary Objective: To evaluate the effectiveness of Otezla (apremilast®) in promoting maintenance of response in those subjects who obtained PASI-75 at week 12 of phototherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apremilast + apremilast | Active comparator | Drug: apremilastapremilast 30mg bid for 12 weeks.followed by apremilast 30 mg bid for 24 weeks |
| apremilast + placebo | Placebo comparator | Drug: apremilastapremilast 30mg bid for 12 weeks followed by placebo bid for 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Subjects who meet any of the following criteria will be excluded from participation in this study:
- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and/or guttate psoriasis) or drug induced psoriasis
- Subjects with previous exposure to apremilast
- Malignancy or history of malignancy, except for:
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 |
|---|---|---|
| apremilast | Drug | Apremilast + apremilast, apremilast + placebo |
Primary outcome
Number of Participants Maintaining Psoriasis Area Severity Index Score (PASI) 75 at Week 36
Time frame: 36weeks
Analysis of Psoriasis Area Severity Index Score at week 36 to determine number of subjects who maintained PASI 75 at week 36
3 secondary outcomes
Number of Subjects Achieving Psoriasis Area Severity Index Score (PASI) 75 Response at Week 12
Time frame: 12WEEKS
Number of Subjects Achieving Psoriasis Area Severity Index Score 90 at Week 36
Time frame: 36 weeks
Number of Subjects Achieving Physician Global Assessment Score of 0 or 1 at Week 36
Time frame: 36 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Plaque Psoriasis
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
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RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
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Not yet recruitingPhase 3
A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis
Palmoplantar Psoriasis
RecruitingPhase 4
A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
Psoriasis, Overweight or Obesity
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
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.
Jerry Bagel, MD principal investigator
Psoriasis Treatment Center of Central New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing apremilast in people with Plaque Psoriasis, run by Psoriasis Treatment Center of Central New Jersey at 1 site in United States.
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 0 inclusion and 6 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 28 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Maintaining Psoriasis Area Severity Index Score (PASI) 75 at Week 36 (time frame: 36weeks). 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 28 Jan 2019.