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Phase II Study Evaluating the Clinical Efficacy and Safety of GN-037 in Plaque Psoriasis

Primary Purpose

Psoriasis

Status
Recruiting
Phase
Phase 2
Locations
Turkey
Study Type
Interventional
Intervention
GN-037
Clobetasol 17-propionate
Placebo
Sponsored by
GEN İlaç ve Sağlık Ürünleri A.Ş.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring mild to moderate plaque psoriasis, local treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 enrollment. Patients with a Physician's Global Assessment (IGA) score of 3 or 4 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.] 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 Exclusion Criteria: 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 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

Sites / Locations

  • Ankara Etlik City HospitalRecruiting
  • Balıkesir University Health Practice and Research HospitalRecruiting
  • Uludag University Faculty of MedicineRecruiting
  • Pamukkale University Faculty of Medicine HospitalRecruiting
  • Ataturk University Research HospitalRecruiting
  • Istanbul University Cerrahpasa Faculty of MedicineRecruiting
  • Basaksehir Cam and Sakura City HospitalRecruiting
  • Bezmialem Vakif University Faculty of MedicineRecruiting
  • Haydarpasa Numune Training and Research HospitalRecruiting
  • Istanbul Haseki Training and Research HospitalRecruiting
  • Istanbul University Istanbul Faculty of MedicineRecruiting
  • University of Health Sciences Bakırkoy Dr. Sadi Konuk Training and Research HospitalRecruiting
  • İzmir Democracy University Buca Seyfi Demirsoy Training And Research HospitalRecruiting
  • Erciyes University Faculty of MedicineRecruiting
  • Necmettin Erbakan University Meram Faculty of Medicine HospitalRecruiting
  • Mersin University HospitalRecruiting
  • Samsun Ondokuz Mayis University Faculty of MedicineRecruiting
  • Uşak Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

GN-037 cream

Clobetasol 17-propionate

Placebo

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Number and percentage of patients that showed at least 2 points improvement in Physician's Global Assessment (PGA) score at week 4 compared to baseline in each arm
The PGA is a static 6-point (0-5) morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, scaling, and plaque thickness/elevation as guidelines. Higher PGA scores represent more severe disease.
The number and percentage of patients whose target lesion healing scores improved by at least 2 points at week 4 compared to baseline 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 mild disease

Secondary Outcome Measures

Physician's Global Assessment (PGA) - Number and percentage of patients with an PGA score of 0 or 1 and mean change in PGA score at each visit - Number and percentage of patients with an PGA score of 0 or 1 of at week 4 - Number of patients with an
Higher PGA scores represent more severe disease.
The mean change in %BSA affected from baseline at each visit
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 mild disease
Difference in Psoriasis Area Severity Index (PASI) from baseline at week 4 in each arm
The PASI scoring system takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, 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.
Difference in least squares mean percent change from baseline at week 4 in total plaque severity score (TPSS) 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.

Full Information

First Posted
January 10, 2023
Last Updated
August 23, 2023
Sponsor
GEN İlaç ve Sağlık Ürünleri A.Ş.
Collaborators
Monitor CRO
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1. Study Identification

Unique Protocol Identification Number
NCT05706870
Brief Title
Phase II Study Evaluating the Clinical Efficacy and Safety of GN-037 in Plaque Psoriasis
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 7, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GEN İlaç ve Sağlık Ürünleri A.Ş.
Collaborators
Monitor CRO

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
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 6 visits: baseline (day 1), week 2, week 4, week 6 and week 8 which is a follow-up period with observation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
mild to moderate plaque psoriasis, local treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GN-037 cream
Arm Type
Experimental
Arm Description
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.
Arm Title
Clobetasol 17-propionate
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
GN-037
Intervention Description
GN-037
Intervention Type
Drug
Intervention Name(s)
Clobetasol 17-propionate
Intervention Description
Clobetasol 17-propionate
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Number and percentage of patients that showed at least 2 points improvement in Physician's Global Assessment (PGA) score at week 4 compared to baseline in each arm
Description
The PGA is a static 6-point (0-5) morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, scaling, and plaque thickness/elevation as guidelines. Higher PGA scores represent more severe disease.
Time Frame
28 days
Title
The number and percentage of patients whose target lesion healing scores improved by at least 2 points at week 4 compared to baseline in each arm
Description
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 mild disease
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Physician's Global Assessment (PGA) - Number and percentage of patients with an PGA score of 0 or 1 and mean change in PGA score at each visit - Number and percentage of patients with an PGA score of 0 or 1 of at week 4 - Number of patients with an
Description
Higher PGA scores represent more severe disease.
Time Frame
28 days
Title
The mean change in %BSA affected from baseline at each visit
Description
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 mild disease
Time Frame
28 days
Title
Difference in Psoriasis Area Severity Index (PASI) from baseline at week 4 in each arm
Description
The PASI scoring system takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, 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.
Time Frame
28 days
Title
Difference in least squares mean percent change from baseline at week 4 in total plaque severity score (TPSS) in each arm
Description
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.
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 enrollment. Patients with a Physician's Global Assessment (IGA) score of 3 or 4 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.] 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 Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Burhan Engin, Prof Dr
Phone
90 (212) 414 30 00
Email
burhanengin2000@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadir Ulu, MD PhD
Organizational Affiliation
Gen Ilac
Official's Role
Study Chair
Facility Information:
Facility Name
Ankara Etlik City Hospital
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Selda Pelin Kartal, Prof Dr
First Name & Middle Initial & Last Name & Degree
Filiz Canpolat, Prof Dr
Facility Name
Balıkesir University Health Practice and Research Hospital
City
Balıkesir
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatma Arzu Kılıç, Prof Dr
Facility Name
Uludag University Faculty of Medicine
City
Bursa
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emel Bülbül Başkan, Prof Dr
Facility Name
Pamukkale University Faculty of Medicine Hospital
City
Denizli
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nida Kaçar, Prof Dr
Facility Name
Ataturk University Research Hospital
City
Erzurum
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehmet Melikoğlu, Prof Dr
Facility Name
Istanbul University Cerrahpasa Faculty of Medicine
City
Istanbul
ZIP/Postal Code
34786
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Burhan Engin, Prof Dr
Facility Name
Basaksehir Cam and Sakura City Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zafer Türkoğlu, Prof Dr
Facility Name
Bezmialem Vakif University Faculty of Medicine
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Özlem Su Küçük, Prof Dr
Facility Name
Haydarpasa Numune Training and Research Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
İlkin Zindancı, Prof Dr
Facility Name
Istanbul Haseki Training and Research Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gizem Pehlivan Ulutaş, MD
Facility Name
Istanbul University Istanbul Faculty of Medicine
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Algün Polat Ekinci, Prof Dr
Facility Name
University of Health Sciences Bakırkoy Dr. Sadi Konuk Training and Research Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zeynep Topkarcı, MD
Facility Name
İzmir Democracy University Buca Seyfi Demirsoy Training And Research Hospital
City
İzmir
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatma Aslı Hapa, Prof Dr
Facility Name
Erciyes University Faculty of Medicine
City
Kayseri
ZIP/Postal Code
38110
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Levent Çınar, Prof Dr
First Name & Middle Initial & Last Name & Degree
Hatice Çokaklı, MD
Facility Name
Necmettin Erbakan University Meram Faculty of Medicine Hospital
City
Konya
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Recep Dursun, Prof Dr
Facility Name
Mersin University Hospital
City
Mersin
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ümit Türsen, Prof Dr
Facility Name
Samsun Ondokuz Mayis University Faculty of Medicine
City
Samsun
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Müge Güler Özden, Prof Dr
Facility Name
Uşak Training and Research Hospital
City
Uşak
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neslihan Demirel Öğüt, MD

12. IPD Sharing Statement

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Phase II Study Evaluating the Clinical Efficacy and Safety of GN-037 in Plaque Psoriasis

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