PsoriasisPhase 2NCT05706870
Phase II Study Evaluating the Clinical Efficacy and Safety of GN-037 in Plaque Psoriasis
A Phase 2 study testing GN-037 and Clobetasol 17-propionate in people with Psoriasis, run by GEN İlaç ve Sağlık Ürünleri A.Ş. at 18 sites in Turkey (Türkiye).
Trial summary
This Phase II study was designed as a multicenter, randomized, double-blind, placebo-controlled and 3-parallel arm, to assess clinical efficacy, safety, and tolerability of GN-037 versus clobetasol 17-propionate and placebo in patients diagnosed with mild to moderate plaque psoriasis at least 6 months ago Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- GN-037 and Clobetasol 17-propionate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 18 sitesTurkey (Türkiye)
- Study dates
- 7 Dec 2022to 3 Mar 2024
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients between the ages of 18-65
- Patients who can give their written informed consent prior to initiating any evaluation or procedure related to the study.
- Patients with negative SARS-CoV-2 PCR test result
- Patients who were diagnosed with mild or moderate plaque psoriasis at least 6 months ago by a dermatologist and whose diagnosis was confirmed according to the clinical judgment of the research physician at the time of enrolment.
- Patients with a Investigator Global Assessment (IGA) score of 2 or 3 at the screening visit [Face, scalp, palms, soles, armpits, and intertriginous areas will be excluded from this assessment]
- Patients with plaque psoriasis lesions covering a body surface area (BSA) of at least 3% to 12% [Face, scalp, palms, soles, axillae, and intertriginous areas will be excluded from this assessment.]
Show all 14Show fewer
- Patients who received the last psoriasis treatment 4 weeks or before
- Patients who are confirmed to be healthy by medical history and physical examination and who do not have any clinically significant disease/condition other than plaque psoriasis that, at the discretion of the investigator, could affect the study evaluation.
- Patients who can protect the lesion areas from ultraviolet (UV) rays (natural or artificial) during the study
- Female patients: Patients who had a negative pregnancy test at the screening visit, did not breastfeed, did not plan pregnancy during the study, and agreed to use an effective method of contraception until the end of the study.
- Male patients: Patients who agreed to use an effective method of contraception for the duration of the study.
- Patients who can comply with all scheduled visits, laboratory tests, and other study procedures
- Patients with normal adrenocorticotropic hormone (ACTH) stimulation test
- Patients with normal dihydroepiandrostenedione sulfate (DHEAS) levels
Who cannot join
- Patients with a known sensitivity/hypersensitivity to any component of the drugs to be used in the study
- Pregnant or lactating or female patients with a positive pregnancy test
- Patients who are resistant/unresponsive to corticosteroids
- Patients with psoriasis (eg guttate, erythrodermic, exfoliative or pustular) that, in the opinion of the investigating physician, resolves spontaneously or rapidly worsens
- Patients with other inflammatory skin disease (eg, atopic dermatitis, contact dermatitis, eczema, tinea corporis) that, in the opinion of the investigative physician, may affect study evaluations at the targeted treatment sites
- Patients who received phototherapy, photochemotherapy, systemic or local treatment for psoriasis or used systemic anti-inflammatory agents in the last 4 weeks
Show all 14Show fewer
- Patients who received biologic therapy for psoriasis in the last 3 months
- Immunosuppressive or immunocompromised patients (patients who have taken immunosuppressive drugs in the last 2 months will also be excluded)
- Patients who have received any cancer treatment in the last 1 year
- Patients with severe hypertension (systolic blood pressure [SBP] > 160 mmHg or diastolic blood pressure [DBP] > 100 mmHg)
- Patients who cannot comply with the study procedures/rules and cannot be in harmony with the research team
- Patients who have participated in another clinical trial in the last 2 months or who are taking part in another clinical trial concurrently
- Patients with a known abnormality of the hypothalamus-pituitary-adrenal axis (HPA axis)
- Patients using products containing dihydroepiandrostenedione (DHEA) or dihydroepiandrostenedione sulfate (DHEAS) in the last 1 month
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Turkey (Türkiye)18 sites
Ankara Etlik City Hospital
Ankara
Balıkesir University Faculty of Medicine
Balıkesir
Uludag University Faculty of Medicine
Bursa
Pamukkale University Faculty of Medicine
Denizli
Ataturk University Research Hospital
Erzurum
Istanbul University Cerrahpasa Faculty of Medicine
Istanbul, 34786
Basaksehir Cam and Sakura City Hospital
Istanbul
Bezmialem Vakif University Faculty of Medicine
Istanbul
Haydarpasa Numune Training and Research Hospital
Istanbul
Istanbul Haseki Training and Research Hospital
Istanbul
Istanbul University Istanbul Faculty of Medicine
Istanbul
University of Health Sciences Bakırkoy Dr. Sadi Konuk Training and Research Hospital
Istanbul
İzmir Democracy University Buca Seyfi Demirsoy Training And Research Hospital
Izmir
Erciyes University Faculty of Medicine
Kayseri, 38110
Necmettin Erbakan University Meram Faculty of Medicine
Konya
Mersin University Faculty of Medicine
Mersin
Samsun Ondokuz Mayis University Faculty of Medicine
Samsun
Uşak Training and Research Hospital
Uşak
About this study
Official title: A Multicenter Randomized Double-blind Placebo-controlled Parallel Group Phase II Study Evaluating the Clinical Efficacy and Safety of GN-037 Cream Used in the Treatment of Mild to Moderate Plaque Psoriasis
This Phase II study was designed as a multicenter, randomized, double-blind, placebo-controlled and 3-parallel arm, to assess clinical efficacy, safety, and tolerability of GN-037 versus clobetasol 17-propionate and placebo in patients diagnosed with mild to moderate plaque psoriasis at least 6 months ago
Read the detailed description
A total of 190 patients aged between 18-65 years diagnosed with plaque psoriasis are planned to be included in the study. The study consists of three periods:
Screening period: Within 4 weeks before baseline visit (-28 days to 0 days)
Treatment period: 4 weeks
Follow-up period with observation: 4 weeks
The study is planned to last a maximum of 12 weeks for each patient. Study consists of 5 visits: baseline (day 1), week 2, week 4, week 6 and week 8 which is a follow-up period with observation.
- Conditions
- Psoriasis
- Being tested
- GN-037, Clobetasol 17-propionate, Placebo
- Keywords
- mild to moderate plaque psoriasis, local treatment
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GN-037Drug
GN-037
Clobetasol 17-propionateDrug
Clobetasol 17-propionate
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| GN-037 cream | Experimental | Psoriatic patients will receive GN-037 cream in 2:2:1 ratio
Psoriatic patients will receive GN-037 cream twice daily on a selected body target lesion
GN-037 cream will be applied as a thin film layer for 4 weeks. Receives: Drug: GN-037 |
| Clobetasol 17-propionate cream | Active comparator | Clobetasol 17-propionate cream will be applied in 2:2:1 ratio
Psoriatic patients will receive clobetasol 17-propionate cream twice daily on a selected body target lesion
Clobetasol 17-propionate will be applied as a thin film layer for 4 weeks. Receives: Drug: Clobetasol 17-propionate |
| Placebo | Placebo comparator | Placebo cream will be applied in 2:2:1 ratio
Psoriatic patients will receive placebo cream twice daily on a selected body target lesion
Placebo cream will be applied as a thin film layer for 4 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Investigator Global Assessment (IGA) score evaluated at weeks 2, 4, 6 and 8 in each arm.
Improvement will be evaluated as the number and percent of patients with at least 2 points improvement in IGA score, and IGA score equating to 0 or 1.
Measured: 28 days
Secondary outcomes (6)
Mean change in %BSA affected from baseline at weeks 2, 4, 6 and 8 in each arm.
Target plaque area (cm2) was determined by multiplying the longest diameter (cm) of the target plaque by the widest perpendicular diameter (cm). A negative percent change indicates a mild disease.
Measured: 28 days
Improvement in Psoriasis Area Severity Index (PASI) from baseline at weeks 2, 4, 6 and 8 in each arm. Improvement will be evaluated as the number and percent of patients with ≥75% improvement in PASI score.
The PASI scoring system takes into account the overall severity of erythema (redness), induration (plaque thickness) and scaling, and the extent of %Body Surface Area affected with psoriasis. Higher scores indicate more severe disease. PASI is a static assessment made without reference to previous scores.
Measured: 28 days
Mean change in in total plaque severity score (TPSS) from baseline at week 2, 4, 6 and 8 in each arm.
For TPSS, all target lesions were scored individually for signs of induration, scaling, and erythema using a 5-point severity scale: 0 = none; 1 = mild; 2 = moderate; 3 = severe; 4 = very severe. A negative percent change indicates better outcome.
Measured: 28 days
Improvement in target lesion healing from baseline at weeks 2, 4, 6 and 8 in each arm.
Improvement will be evaluated as the number and percent of patients whose target lesion erythema, plaque thickness and scaling score improvement at least 2 points at week 2, 4, 6 and 8 compared to baseline in each arm. Additionally, at which week at least 50% improvement in the target lesion healing is observed in each arm will be evaluated.
Target plaque area (cm2) was determined by multiplying the longest diameter (cm) of the target plaque by the widest perpendicular diameter (cm).
Measured: .28 days
Improvement in Dermatology Life Quality Index (DLQI)
Improvement in DLQI at weeks 4 and 8 compared to baseline.
Measured: 28 days
Safety, Adverse Events and Serious Adverse Events
Safety will be evaluated as the number and ratio of patients with adverse events and serious adverse events in each arm. Additionally, number of adverse events which resulted in discontinuation of the study treatment in each arm will be evaluated
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start7 Dec 2022
- Primary completion4 Jan 2024
- Study completion3 Mar 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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- GEN İlaç ve Sağlık Ürünleri A.Ş.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Monitor CRO
- Responsible party
- Sponsor
- Investigators
- Nadir Ulu, MD PhD, Study chair, Gen Ilac
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706870
- Sponsor's protocol ID
- MON886.151.7
- Status last verified
- Mar 2024
- First submitted
- 10 Jan 2023
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Engin B, Guler Ozden M, Karstarli Bakay OS, Kartal SP, Zindanci I, Cinar SL, Dursun R, Pehlivan Ulutas G, Ozkok Akbulut TO, Hapa FA, Bulbul Baskan E, Melikoglu M, Polat Ekinci A, Demirel Ogut N, Hizli P, Turkoglu Z, Kucuk OS, Topkarci Z, Tursen U, Canpolat F, Ucgun H, Yasar S, Temiz SA, Dogramaci AC, Altug S, Kozlu S, Ulu N, Serdaroglu S. A Multicenter Randomized Double-Blind Vehicle-Controlled Parallel Group Phase 2 Study Evaluating the Efficacy and Safety of GN-037 Cream in Patients with Mild-to-Moderate Plaque Psoriasis. Dermatol Ther (Heidelb). 2024 Dec;14(12):3337-3350. doi: 10.1007/s13555-024-01301-1. Epub 2024 Nov 22.
PubMed 39578347Sezer Z, Inal A, Cinar SL, Mazicioglu MM, Altug S, Karasulu HY, Diril M, Mehmetoglu Al A, Kozlu S, Ulu N. Safety and Efficacy of a Novel Combination Cream (GN-037) in Healthy Volunteers and Patients with Plaque Psoriasis: A Phase 1 Trial. Dermatol Ther (Heidelb). 2023 Jul;13(7):1489-1501. doi: 10.1007/s13555-023-00939-7. Epub 2023 Jun 10.
PubMed 37300792
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Double-blind Placebo-controlled Parallel Group Phase II Study Evaluating the Clinical Efficacy and Safety of GN-037 Cream Used in the Treatment of Mild to Moderate Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT05706870
- Acronym / sponsor ID
- MON886.151.7
- Conditions
- Psoriasis
- Keywords
- mild to moderate plaque psoriasis, local treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- GEN İlaç ve Sağlık Ürünleri A.Ş.Industry (pharma, biotech, devices)
- Collaborators
- Monitor CRO
- Study start
- 7 Dec 2022 (actual)
- Primary completion
- 4 Jan 2024 (actual)
- Study completion
- 3 Mar 2024 (actual)
- First posted
- 31 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.
This Phase II study was designed as a multicenter, randomized, double-blind, placebo-controlled and 3-parallel arm, to assess clinical efficacy, safety, and tolerability of GN-037 versus clobetasol 17-propionate and placebo in patients diagnosed with mild to moderate plaque psoriasis at least 6 months ago
Detailed description
A total of 190 patients aged between 18-65 years diagnosed with plaque psoriasis are planned to be included in the study. The study consists of three periods:
Screening period: Within 4 weeks before baseline visit (-28 days to 0 days)
Treatment period: 4 weeks
Follow-up period with observation: 4 weeks
The study is planned to last a maximum of 12 weeks for each patient. Study consists of 5 visits: baseline (day 1), week 2, week 4, week 6 and week 8 which is a follow-up period with observation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GN-037 cream | Experimental | Drug: GN-037Psoriatic patients will receive GN-037 cream in 2:2:1 ratio Psoriatic patients will receive GN-037 cream twice daily on a selected body target lesion GN-037 cream will be applied as a thin film layer for 4 weeks. |
| Clobetasol 17-propionate cream | Active comparator | Drug: Clobetasol 17-propionateClobetasol 17-propionate cream will be applied in 2:2:1 ratio Psoriatic patients will receive clobetasol 17-propionate cream twice daily on a selected body target lesion Clobetasol 17-propionate will be applied as a thin film layer for 4 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo cream will be applied in 2:2:1 ratio Psoriatic patients will receive placebo cream twice daily on a selected body target lesion Placebo cream will be applied as a thin film layer for 4 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male and female patients between the ages of 18-65
- Patients who can give their written informed consent prior to initiating any evaluation or procedure related to the study.
- Patients with negative SARS-CoV-2 PCR test result
- Patients who were diagnosed with mild or moderate plaque psoriasis at least 6 months ago by a dermatologist and whose diagnosis was confirmed according to the clinical judgment of the research physician at the time of enrolment.
- Patients with a Investigator Global Assessment (IGA) score of 2 or 3 at the screening visit [Face, scalp, palms, soles, armpits, and intertriginous areas will be excluded from this assessment]
Key exclusion criteria (14 listed)
- Patients with a known sensitivity/hypersensitivity to any component of the drugs to be used in the study
- Pregnant or lactating or female patients with a positive pregnancy test
- Patients who are resistant/unresponsive to corticosteroids
- Patients with psoriasis (eg guttate, erythrodermic, exfoliative or pustular) that, in the opinion of the investigating physician, resolves spontaneously or rapidly worsens
- Patients with other inflammatory skin disease (eg, atopic dermatitis, contact dermatitis, eczema, tinea corporis) that, in the opinion of the investigative physician, may affect study evaluations at the targeted treatment sites
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 |
|---|---|---|
| GN-037GN-037 | Drug | GN-037 cream |
| Clobetasol 17-propionateClobetasol 17-propionate | Drug | Clobetasol 17-propionate cream |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Improvement in Investigator Global Assessment (IGA) score evaluated at weeks 2, 4, 6 and 8 in each arm.
Time frame: 28 days
Improvement will be evaluated as the number and percent of patients with at least 2 points improvement in IGA score, and IGA score equating to 0 or 1.
6 secondary outcomes
Mean change in %BSA affected from baseline at weeks 2, 4, 6 and 8 in each arm.
Time frame: 28 days
Improvement in Psoriasis Area Severity Index (PASI) from baseline at weeks 2, 4, 6 and 8 in each arm. Improvement will be evaluated as the number and percent of patients with ≥75% improvement in PASI score.
Time frame: 28 days
Mean change in in total plaque severity score (TPSS) from baseline at week 2, 4, 6 and 8 in each arm.
Time frame: 28 days
Improvement in target lesion healing from baseline at weeks 2, 4, 6 and 8 in each arm.
Time frame: .28 days
Improvement in Dermatology Life Quality Index (DLQI)
Time frame: 28 days
Safety, Adverse Events and Serious Adverse Events
Time frame: 56 days
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 Jul 2025.
- Derived from this study: PubMed 39578347Engin B, Guler Ozden M, Karstarli Bakay OS, Kartal SP, Zindanci I, Cinar SL, Dursun R, Pehlivan Ulutas G, Ozkok Akbulut TO, Hapa FA, Bulbul Baskan E, Melikoglu M, Polat Ekinci A, Demirel Ogut N, Hizli P, Turkoglu Z, Kucuk OS, Topkarci Z, Tursen U, Canpolat F, Ucgun H, Yasar S, Temiz SA, Dogramaci AC, Altug S, Kozlu S, Ulu N, Serdaroglu S. A Multicenter Randomized Double-Blind Vehicle-Controlled Parallel Group Phase 2 Study Evaluating the Efficacy and Safety of GN-037 Cream in Patients with Mild-to-Moderate Plaque Psoriasis. Dermatol Ther (Heidelb). 2024 Dec;14(12):3337-3350. doi: 10.1007/s13555-024-01301-1. Epub 2024 Nov 22.
- Derived from this study: PubMed 37300792Sezer Z, Inal A, Cinar SL, Mazicioglu MM, Altug S, Karasulu HY, Diril M, Mehmetoglu Al A, Kozlu S, Ulu N. Safety and Efficacy of a Novel Combination Cream (GN-037) in Healthy Volunteers and Patients with Plaque Psoriasis: A Phase 1 Trial. Dermatol Ther (Heidelb). 2023 Jul;13(7):1489-1501. doi: 10.1007/s13555-023-00939-7. Epub 2023 Jun 10.
Related trials for Psoriasis
RecruitingPhase 4
A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
Psoriasis, Colitis, Ulcerative
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Plaque Psoriasis Involving Special Areas (Scalp, Genital, and/or Palms of the Hands and the Soles of the Feet)
Plaque Psoriasis
RecruitingObservational study
A Study of Persistence to Guselkumab Treatment in Participants With Moderate-to-Severe Plaque Psoriasis in Romania
Psoriasis
Active, not recruitingPhase 3
A Long-term Extension Study of Ustekinumab in Pediatric Participants
Crohn Disease, Colitis, Ulcerative
RecruitingObservational study
A Study of Guselkumab Given After Ustekinumab in Participants With Moderate to Severe Psoriasis in Routine Clinical Practice
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.
Nadir Ulu, MD PhD study chair
Gen Ilac
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GN-037 and Clobetasol 17-propionate in people with Psoriasis, run by GEN İlaç ve Sağlık Ürünleri A.Ş. at 18 sites in Turkey (Türkiye).
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 14 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: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Turkey (Türkiye). 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Improvement in Investigator Global Assessment (IGA) score evaluated at weeks 2, 4, 6 and 8 in each arm. (time frame: 28 days). 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 NCT05706870, 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 16 Jul 2025.