Psoriasis VulgarisPhase 4NCT06475586
Effect of Semaglutide on the Psoriatic Lesions in Patients With Type 2 Diabetes Mellitus
A Phase 4 study testing Semaglutide in people with Psoriasis Vulgaris and Diabetes Type 2, run by University of Banja Luka at 1 site in Bosnia and Herzegovina.
Trial summary
The use of semaglutide in patients with DMT2 and psoriasis contributes to improving the clinical picture of psoriasis and reducing the inflammatory response Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psoriasis Vulgaris, Diabetes Type 2
- What is being tested?
- Semaglutide
- 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 siteBosnia and Herzegovina
- Study dates
- 3 May 2023to 10 Jun 2024
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who signed a personal consent to participate in the study,
- Patients with a typical clinical picture of moderately-severe to severe plaque psoriasis (PASI SCORE ≥10) and
- DMT2 diagnosed at least 6 months before inclusion in the study,
- Patients who were not treated with immunosuppressive therapy.
Who cannot join
- Other forms of psoriasis,
- Other chronic, inflammatory diseases (data obtained by reviewing the medical history),
- Drugs that can cause the appearance of psoriasis (lithium, systemic antimalarials, systemic corticosteroids) - for the past 3 months,
- Systemic therapy of vulgaris psoriasis 3 months before inclusion in the study,
- Patients on therapy with other GLP-1 RAs except semaglutide (liraglutide, dulaglutide, lixisenatide), SGLT-2 inhibitors (empagliflozin and dapagliflozin) and NSAIDs, photo UVB therapy,
- Patients who did not personally sign consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
Bosnia and Herzegovina1 site
University of Banja Luka, Faculty of Medicine
Banja Luka, 78000
About this study
Official title: Effect of Semaglutide on the Inflammatory Response and Clinical Course of Psoriatic Lesions in Patients With Type 2 Diabetes Mellitus
The use of semaglutide in patients with DMT2 and psoriasis contributes to improving the clinical picture of psoriasis and reducing the inflammatory response
Read the detailed description
After being informed about the study and potential risiks all patients giving written informed consent will undergo a 1-week screening period to determine eliglibility for study entry at week 0, patients who meet the eligibility requirements will be randomized.
Study was conducted in two cohort Cohort 1. Patients with DMT2 and psoriasis, who are already on metformin therapy in the maximally tolerated dose and to whom semaglutide will be introduced into the therapy, in the maximum tolerated dose of semaglutide (0.25mg, 0.5mg per week or 1.0mg per week).
Cohort 2. Patients with DMT2 and psoriasis, who are already on metformin therapy in the maximally tolerated dose and other oral antidiabetics, except on therapy with GLP-1 RA and SGLT-2 inhibitors.
- Conditions
- Psoriasis Vulgaris, Diabetes Type 2
- Being tested
- Semaglutide
- Keywords
- psoriasis, diabetes type 2, semaglutide, cytokine
- Medical subject headings
- Diabetes Mellitus, Type 2, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Also called ozempic
0.25mg 4 weeks, 0.5mg per 4 weeks and 1.0mg per 4 weeks, totally 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| semaglutide | Experimental | The initial dose of the medicine is 0.25 mg once a week, for the duration of 4 weeks. Then the dose is increased to 0.5 mg per week, for the duration of 4 weeks. After at least 4 weeks, the dose can be increased from 0.5 mg to 1 mg per 4 week. Totally 12 weeks Receives: Drug: Semaglutide |
| controled group | No intervention | Patients with DMT2 and psoriasis, who are already on metformin therapy in the maximally tolerated dose and other oral antidiabetics, except on therapy with GLP-1 RA and SGLT-2 inhibitors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical characteristics of patients with psoriasis
clinical examination by a dermatovenerologist (PASI SCORE- Psoriasis Area and Severity Index). To assess disease activity, i.e. skin surface affected by changes (erythema, infiltration and extent of squamous matter), investigators used the PASI score. According to the European consensus, mild psoriasis is defined as PASI≤10 and DLQI≤10, while moderate psoriasis is defined as PASi>10 and DLQI>10.
Measured: up to 12 weeks
Determine BMI Body Mass Index
e.g., weight and height will be combined to report BMI in kg/m^2
Measured: up to 12 weeks
Serum values of TNFa, IL-1b, IL-6, IL-17 and IL-23
ELISA-Enyzme linked immunosorbent assay technique -Bio Legend ELISA MAX Deluxe Sets, Bio Legend, San Diego, CA.
same units
Measured: up to12 weeks
Correlation between the course and prognosis of the disease after the treatment
the Wilcoxon Mann-Whitney test for two independent groups will be used. Spearman's correlation analysis will be used to determine the correlation between parameters, binary logistic regression
Measured: up to 12 weeks
Change in HgbA1C,
by enzymatic method with hexakinase glucose-6-phosphate dehydrogenase (Roche Diagnostic) will be expressed in %
Measured: up to 12 weeks
lipid status, change in Total cholesterol (TC), low-density lipoprotein(LDL), high-density lipoprotein (HDL) and triglicerides
Biochemical analyses Clinical colorimetric tests, and results will be expressed in same units
Measured: up to 12 weeks
fasting insulin
Biochemical analyses
Measured: up to 12 weeks
Change in inflammation marker level: CRP,
Biochemical analyses-Turbid metric test
Measured: up to 12 weeks
fasting glycemia
by enzymatic method with hexakinase glucose-6-phosphate dehydrogenase (Roche Diagnostic)
Measured: up to 12 weeks
urate
Biochemical analyses
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start3 May 2023
- Primary completion1 Mar 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psoriasis VulgarisStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Banja Luka
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jelena Petkovic-Dabic, Principal investigator, Faculty of Medicine Banja Luka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475586
- Sponsor's protocol ID
- 18/4.48/23
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Costanzo G, Curatolo S, Busa B, Belfiore A, Gullo D. Two birds one stone: semaglutide is highly effective against severe psoriasis in a type 2 diabetic patient. Endocrinol Diabetes Metab Case Rep. 2021 Jan 1;2021:21-0007. doi: 10.1530/EDM-21-0007. Epub 2021 Aug 1.
PubMed 34463640Nauck MA, Quast DR, Wefers J, Meier JJ. GLP-1 receptor agonists in the treatment of type 2 diabetes - state-of-the-art. Mol Metab. 2021 Apr;46:101102. doi: 10.1016/j.molmet.2020.101102. Epub 2020 Oct 14.
PubMed 33068776
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Semaglutide on the Inflammatory Response and Clinical Course of Psoriatic Lesions in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06475586
- Acronym / sponsor ID
- 18/4.48/23
- Conditions
- Psoriasis Vulgaris, Diabetes Type 2
- Keywords
- psoriasis, diabetes type 2, semaglutide, cytokine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Banja LukaUniversity, hospital or other
- Study start
- 3 May 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 26 Jun 2024 (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 use of semaglutide in patients with DMT2 and psoriasis contributes to improving the clinical picture of psoriasis and reducing the inflammatory response
Detailed description
After being informed about the study and potential risiks all patients giving written informed consent will undergo a 1-week screening period to determine eliglibility for study entry at week 0, patients who meet the eligibility requirements will be randomized.
Study was conducted in two cohort Cohort 1. Patients with DMT2 and psoriasis, who are already on metformin therapy in the maximally tolerated dose and to whom semaglutide will be introduced into the therapy, in the maximum tolerated dose of semaglutide (0.25mg, 0.5mg per week or 1.0mg per week).
Cohort 2. Patients with DMT2 and psoriasis, who are already on metformin therapy in the maximally tolerated dose and other oral antidiabetics, except on therapy with GLP-1 RA and SGLT-2 inhibitors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| semaglutide | Experimental | Drug: SemaglutideThe initial dose of the medicine is 0.25 mg once a week, for the duration of 4 weeks. Then the dose is increased to 0.5 mg per week, for the duration of 4 weeks. After at least 4 weeks, the dose can be increased from 0.5 mg to 1 mg per 4 week. Totally 12 weeks |
| controled group | No intervention | –Patients with DMT2 and psoriasis, who are already on metformin therapy in the maximally tolerated dose and other oral antidiabetics, except on therapy with GLP-1 RA and SGLT-2 inhibitors. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who signed a personal consent to participate in the study,
- Patients with a typical clinical picture of moderately-severe to severe plaque psoriasis (PASI SCORE ≥10) and
- DMT2 diagnosed at least 6 months before inclusion in the study,
- Patients who were not treated with immunosuppressive therapy.
Key exclusion criteria (6 listed)
- Other forms of psoriasis,
- Other chronic, inflammatory diseases (data obtained by reviewing the medical history),
- Drugs that can cause the appearance of psoriasis (lithium, systemic antimalarials, systemic corticosteroids) - for the past 3 months,
- Systemic therapy of vulgaris psoriasis 3 months before inclusion in the study,
- Patients on therapy with other GLP-1 RAs except semaglutide (liraglutide, dulaglutide, lixisenatide), SGLT-2 inhibitors (empagliflozin and dapagliflozin) and NSAIDs, photo UVB therapy,
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 |
|---|---|---|
| SemaglutideAlso: ozempic0.25mg 4 weeks, 0.5mg per 4 weeks and 1.0mg per 4 weeks, totally 12 weeks | Drug | semaglutide |
Primary outcome
clinical characteristics of patients with psoriasis
Time frame: up to 12 weeks
clinical examination by a dermatovenerologist (PASI SCORE- Psoriasis Area and Severity Index). To assess disease activity, i.e. skin surface affected by changes (erythema, infiltration and extent of squamous matter), investigators used the PASI score. According to the European consensus, mild psoriasis is defined as PASI≤10 and DLQI≤10, while moderate psoriasis is defined as PASi>10 and DLQI>10.
Determine BMI Body Mass Index
Time frame: up to 12 weeks
e.g., weight and height will be combined to report BMI in kg/m^2
Serum values of TNFa, IL-1b, IL-6, IL-17 and IL-23
Time frame: up to12 weeks
ELISA-Enyzme linked immunosorbent assay technique -Bio Legend ELISA MAX Deluxe Sets, Bio Legend, San Diego, CA. same units
Correlation between the course and prognosis of the disease after the treatment
Time frame: up to 12 weeks
the Wilcoxon Mann-Whitney test for two independent groups will be used. Spearman's correlation analysis will be used to determine the correlation between parameters, binary logistic regression
Change in HgbA1C,
Time frame: up to 12 weeks
by enzymatic method with hexakinase glucose-6-phosphate dehydrogenase (Roche Diagnostic) will be expressed in %
lipid status, change in Total cholesterol (TC), low-density lipoprotein(LDL), high-density lipoprotein (HDL) and triglicerides
Time frame: up to 12 weeks
Biochemical analyses Clinical colorimetric tests, and results will be expressed in same units
fasting insulin
Time frame: up to 12 weeks
Biochemical analyses
Change in inflammation marker level: CRP,
Time frame: up to 12 weeks
Biochemical analyses-Turbid metric test
fasting glycemia
Time frame: up to 12 weeks
by enzymatic method with hexakinase glucose-6-phosphate dehydrogenase (Roche Diagnostic)
urate
Time frame: up to 12 weeks
Biochemical analyses
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 1 Jul 2024.
- Results publication: PubMed 34463640Costanzo G, Curatolo S, Busa B, Belfiore A, Gullo D. Two birds one stone: semaglutide is highly effective against severe psoriasis in a type 2 diabetic patient. Endocrinol Diabetes Metab Case Rep. 2021 Jan 1;2021:21-0007. doi: 10.1530/EDM-21-0007. Epub 2021 Aug 1.
- Results publication: PubMed 33068776Nauck MA, Quast DR, Wefers J, Meier JJ. GLP-1 receptor agonists in the treatment of type 2 diabetes - state-of-the-art. Mol Metab. 2021 Apr;46:101102. doi: 10.1016/j.molmet.2020.101102. Epub 2020 Oct 14.
- Individual participant dataSharing planned: Yes
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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.
Jelena Petkovic-Dabic principal investigator
Faculty of Medicine Banja Luka
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 Semaglutide in people with Psoriasis Vulgaris and Diabetes Type 2, run by University of Banja Luka at 1 site in Bosnia and Herzegovina.
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 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 1 Jul 2024. 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 Bosnia and Herzegovina. 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 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?
clinical characteristics of patients with psoriasis (time frame: up to 12 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06475586, which also lists 2 linked publications.
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 1 Jul 2024.