Moderate to Severe Plaque PsoriasisPhase 4ItchNCT03146247
Analysis of the Pathogenesis of Itch in Response to Apremilast Therapy in Psoriasis Patients
A Phase 4 study testing Apremilast;Apremilast;Apremilast 10 MG; 20 MG; 30 MG Oral Tablet in people with Moderate to Severe Plaque Psoriasis, run by Diamant Thaci at 1 site in Germany.
Trial summary
This study aims to identify and describe the presence of itch active molecules in psoriasis and response to treatment with apremilast. This data will be complemented by immunohistochemical data determining nerve ending density and neuropeptide concentrations before and during treatment and correlated with patient… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Plaque Psoriasis
- What is being tested?
- Apremilast;Apremilast;Apremilast 10 MG; 20 MG; 30 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- 23 Oct 2017to 1 Mar 2019
- Phase
- Phase 4
- 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
- Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give written, signed and dated informed consent before any study related activity is performed.
- Subjects must be at least 18 years of age at time of enrollment
- Patients with chronic moderate to severe plaque type psoriasis who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA)
- Subjects must have a score in the numerical rating scale (NRS, see 12.4) >5 at baseline
- Women of childbearing potential* and males with female partners of child bearing potential must be ready and able to use highly effective methods of birth control per ICH M3(R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.
- Women of childbearing potential are defined as:
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- Having experienced menarche and
- not Postmenopausal (12 months with no menses without an alternative medical cause) and
- not permanently sterilized (e.g. tubal occlusion, hysterectomy, bilateral oophorectomy or bilateral salpingectomy)
Who cannot join
- Patients with previous treatment with Apremilast
- Patients incapable of giving full informed consent.Patients enrolled in other clinical trials
- Allergies against Apremilast or any of the inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide red, iron oxide yellow (20 and 30 mg only) and iron oxide black (30 mg only)
- Rifampicin, Phenobarbital, Carbamazepine, Phenytoin, enzalutamid, mitotan or St John's Wort as concomitant medication
- Patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption
- Allergy to local anaesthetic or latex
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- Pregnancy/Lactation
- Patients with known HIV infection and active or uncontrolled hepatitis B or C infection
- Patients with known disposition for excessive keloid formation or wound healing disorders
- Patients with other forms than chronic plaque type psoriasis especially drug-induced psoriasis
- Patients who cannot tolerate the complete dose used in this study due to medical conditions e.g. due to kidney insufficiency
- Patients with depressive symptom in PHQ-D in visit 1
- Concomitant medication that can cause psychiatric symptoms
- Psychiatric disorders
Trial locations and contacts
1 site in 1 country.
Germany1 site
Comprehensive Center for Inflammation Medicine, UKSH
Lübeck, 23538
About this study
This study aims to identify and describe the presence of itch active molecules in psoriasis and response to treatment with apremilast. This data will be complemented by immunohistochemical data determining nerve ending density and neuropeptide concentrations before and during treatment and correlated with patient reported outcome. It is important to underscore that itch may interfere with various aspects of patient functioning, emotions and social status and should therefore be adequately addressed while treating patients with psoriasis
- Conditions
- Moderate to Severe Plaque Psoriasis
- Being tested
- Apremilast;Apremilast;Apremilast 10 MG; 20 MG; 30 MG Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apremilast;Apremilast;Apremilast 10 MG; 20 MG; 30 MG Oral TabletDrug
All patients are scheduled to receive Apremilast with a titration phase of one week, followed by 23 weeks of regular treatment.
| Study group | Role | What they receive |
|---|---|---|
| One arm | Other | all patients receive same dose and dosing regimen with Apremilast Receives: Drug: Apremilast;Apremilast;Apremilast 10 MG; 20 MG; 30 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunoreactive nerve fibers
Proportion of patients reaching 50% reduction of PGP 9-5- immunoreactive nerve fibers at visit 6 (week 16) compared to visit 1 (week 0) measured with immunohistochemical methods
Measured: until week 16
Secondary outcomes (1)
PASI improvement
Proportion of patients achieving at least 50 % of improvement of PASI at visit 6 (week 16) compared to visit 1 (week 0)
Measured: until week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start23 Oct 2017
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Why it stopped: recruitment was not started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diamant Thaci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Diamant Thaci, University of Luebeck
- Investigators
- Diamant Thaci, Prof., Principal investigator, Universität zu Lübeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146247
- Sponsor's protocol ID
- C16.Pso-002
- Other IDs
- 2016-002432-32, 2016
- Acronym
- Itch
- Status last verified
- Apr 2019
- First submitted
- 5 May 2017
- Last updated
- 18 Apr 2019
- 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 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Pathogenesis of Itch in Response to Apremilast Therapy in Psoriasis Patients
- ClinicalTrials.gov ID
- NCT03146247
- Acronym / sponsor ID
- Itch / C16.Pso-002
- Conditions
- Moderate to Severe Plaque Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: recruitment was not started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Diamant ThaciUniversity, hospital or other
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 9 May 2017 (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 study aims to identify and describe the presence of itch active molecules in psoriasis and response to treatment with apremilast. This data will be complemented by immunohistochemical data determining nerve ending density and neuropeptide concentrations before and during treatment and correlated with patient reported outcome. It is important to underscore that itch may interfere with various aspects of patient functioning, emotions and social status and should therefore be adequately addressed while treating patients with psoriasis
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One arm | Other | Drug: Apremilast;Apremilast;Apremilast 10 MG; 20 MG; 30 MG Oral Tabletall patients receive same dose and dosing regimen with Apremilast |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give written, signed and dated informed consent before any study related activity is performed.
- Subjects must be at least 18 years of age at time of enrollment
- Patients with chronic moderate to severe plaque type psoriasis who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA)
- Subjects must have a score in the numerical rating scale (NRS, see 12.4) >5 at baseline
- Women of childbearing potential* and males with female partners of child bearing potential must be ready and able to use highly effective methods of birth control per ICH M3(R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.
Key exclusion criteria (14 listed)
- Patients with previous treatment with Apremilast
- Patients incapable of giving full informed consent.Patients enrolled in other clinical trials
- Allergies against Apremilast or any of the inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide red, iron oxide yellow (20 and 30 mg only) and iron oxide black (30 mg only)
- Rifampicin, Phenobarbital, Carbamazepine, Phenytoin, enzalutamid, mitotan or St John's Wort as concomitant medication
- Patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption
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;Apremilast;Apremilast 10 MG; 20 MG; 30 MG Oral TabletAll patients are scheduled to receive Apremilast with a titration phase of one week, followed by 23 weeks of regular treatment. | Drug | One arm |
Primary outcome
Immunoreactive nerve fibers
Time frame: until week 16
Proportion of patients reaching 50% reduction of PGP 9-5- immunoreactive nerve fibers at visit 6 (week 16) compared to visit 1 (week 0) measured with immunohistochemical methods
1 secondary outcome
PASI improvement
Time frame: until week 16
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- 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.
Diamant Thaci, Prof. principal investigator
Universität zu Lübeck
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;Apremilast;Apremilast 10 MG; 20 MG; 30 MG Oral Tablet in people with Moderate to Severe Plaque Psoriasis, run by Diamant Thaci at 1 site in Germany.
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 9 inclusion and 14 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: withdrawn, as of the sponsor's last update on 18 Apr 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 Germany. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Immunoreactive nerve fibers (time frame: until 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 18 Apr 2019.