PsoriasisPhase 2/3NCT05684744
Roflumilast Versus Methotrexate in Psoriasis
A Phase 2/3 study testing Roflumilast and Methotrexate in people with Psoriasis, run by Cairo University at 1 site in Egypt.
Trial summary
Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor, which is approved in its oral form for chronic obstructive pulmonary disease, and in its topical form in the treatment of plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Roflumilast and Methotrexate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Jan 2023to 14 May 2023
- Phase
- Phase 2/3
- 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
- Patients with psoriasis vulgaris
- Psoriatic patients not receiving any relevant systemic treatment for at least 4 weeks before initiation of our study
- Psoriatic patients not receiving any relevant topical treatment for at least 2 weeks before initiation of our study
Who cannot join
- Erythrodermic or pustular psoriasis
- Pregnant and lactating females
- Patients with autoimmune diseases e.g. systemic lupus erythematosus
- Patients with solid or hematological malignancies e.g., breast cancer, leukemia, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Roflumilast Versus Methotrexate in the Treatment of Psoriasis
Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor, which is approved in its oral form for chronic obstructive pulmonary disease, and in its topical form in the treatment of plaque psoriasis. Methotrexate is one of the conventional systemic treatments of psoriasis, so the aim of this study is to compare the efficacy and safety of roflumilast and methotrexate in the treatment of psoriasis
Read the detailed description
Phosphodiesterase (PDE-4) activity was found to be greater in psoriatic skin than in healthy skin. Inhibition of PDE-4 inhibits the hydrolysis of cyclic AMP in inflammatory cells, which increases intracellular cAMP and results in down-regulation of immune modulators, including tumor necrosis factor (TNF)- α, interferon-γ, interleukin (IL)-17, and IL-23. Roflumilast is a potent and selective inhibitor of PDE-4 which is already approved in its oral form for chronic obstructive pulmonary disease. Regarding Roflumilast's topical form, it is currently also approved in the treatment of psoriasis. Lebwohl et al., 2020 found that roflumilast cream was efficacious in reducing the severity of psoriasis in a 12-week, randomized, double-blind, placebo vehicle-controlled trial.
- Conditions
- Psoriasis
- Being tested
- Roflumilast, Methotrexate
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoflumilastDrug
Also called Roflumilast oral
The patients will receive oral roflumilast in a dose of 500 mcg per day for 12 weeks
MethotrexateDrug
Also called Methotrexate tablets
The patients will receive methotrexate in a dose of 0.2- 0.4 mg/kg/week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Roflumilast | Experimental | oral roflumilast in a dose of 500 mcg per day Receives: Drug: Roflumilast |
| Methotrexate | Active comparator | oral methotrexate in a dose of 0.2- 0.4 mg/kg/week Receives: Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis Severity Index (PASI) before and after Roflumilast
Comparison of Psoriasis Severity Index (PASI) before and after treatment with Roflumilast, where the lower score indicates clinical improvement. PASI score ranges from 0-72.
Measured: 12 weeks
Psoriasis Severity Index (PASI) change with Roflumilast Vs Methotrexate
Comparison of change of Psoriasis Severity Index (PASI) after treatment with roflumilast and after treatment of methotrexate where the lower score indicates clinical improvement. PASI score ranges from 0-72.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start9 Jan 2023
- Primary completion9 May 2023
- Study completion14 May 2023
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.
- More trials run by Cairo UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Saadi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684744
- Sponsor's protocol ID
- Kapu27
- Status last verified
- May 2023
- First submitted
- 5 Jan 2023
- Last updated
- 16 May 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Roflumilast Versus Methotrexate in the Treatment of Psoriasis
- ClinicalTrials.gov ID
- NCT05684744
- Acronym / sponsor ID
- Kapu27
- Conditions
- Psoriasis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 9 May 2023 (actual)
- Study completion
- 14 May 2023 (actual)
- First posted
- 13 Jan 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.
Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor, which is approved in its oral form for chronic obstructive pulmonary disease, and in its topical form in the treatment of plaque psoriasis. Methotrexate is one of the conventional systemic treatments of psoriasis, so the aim of this study is to compare the efficacy and safety of roflumilast and methotrexate in the treatment of psoriasis
Detailed description
Phosphodiesterase (PDE-4) activity was found to be greater in psoriatic skin than in healthy skin. Inhibition of PDE-4 inhibits the hydrolysis of cyclic AMP in inflammatory cells, which increases intracellular cAMP and results in down-regulation of immune modulators, including tumor necrosis factor (TNF)- α, interferon-γ, interleukin (IL)-17, and IL-23. Roflumilast is a potent and selective inhibitor of PDE-4 which is already approved in its oral form for chronic obstructive pulmonary disease. Regarding Roflumilast's topical form, it is currently also approved in the treatment of psoriasis. Lebwohl et al., 2020 found that roflumilast cream was efficacious in reducing the severity of psoriasis in a 12-week, randomized, double-blind, placebo vehicle-controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Roflumilast | Experimental | Drug: Roflumilastoral roflumilast in a dose of 500 mcg per day |
| Methotrexate | Active comparator | Drug: Methotrexateoral methotrexate in a dose of 0.2- 0.4 mg/kg/week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with psoriasis vulgaris
- Psoriatic patients not receiving any relevant systemic treatment for at least 4 weeks before initiation of our study
- Psoriatic patients not receiving any relevant topical treatment for at least 2 weeks before initiation of our study
Key exclusion criteria (4 listed)
- Erythrodermic or pustular psoriasis
- Pregnant and lactating females
- Patients with autoimmune diseases e.g. systemic lupus erythematosus
- Patients with solid or hematological malignancies e.g., breast cancer, leukemia, etc.
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 |
|---|---|---|
| RoflumilastAlso: Roflumilast oralThe patients will receive oral roflumilast in a dose of 500 mcg per day for 12 weeks | Drug | Roflumilast |
| MethotrexateAlso: Methotrexate tabletsThe patients will receive methotrexate in a dose of 0.2- 0.4 mg/kg/week for 12 weeks | Drug | Methotrexate |
Primary outcome
Psoriasis Severity Index (PASI) before and after Roflumilast
Time frame: 12 weeks
Comparison of Psoriasis Severity Index (PASI) before and after treatment with Roflumilast, where the lower score indicates clinical improvement. PASI score ranges from 0-72.
Psoriasis Severity Index (PASI) change with Roflumilast Vs Methotrexate
Time frame: 12 weeks
Comparison of change of Psoriasis Severity Index (PASI) after treatment with roflumilast and after treatment of methotrexate where the lower score indicates clinical improvement. PASI score ranges from 0-72.
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 16 May 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Roflumilast and Methotrexate in people with Psoriasis, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 4 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 16 May 2023. 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 Egypt. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Psoriasis Severity Index (PASI) before and after Roflumilast (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 16 May 2023.