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

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

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Placebo; Drug: GN-037; Drug: Clobetasol 17-propionate

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 Type: Interventional
• Enrollment (Actual): 190
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Burhan Engin, Prof Dr; Phone Number: 90 (212) 414 30 00; Email: burhanengin2000@gmail.com

Study Locations

• Turkey
  • Ankara, Turkey
    • Ankara Etlik City Hospital
  • Balıkesir, Turkey
    • Balıkesir University Faculty of Medicine
  • Bursa, Turkey
    • Uludag University Faculty of Medicine
  • Denizli, Turkey
    • Pamukkale University Faculty of Medicine
  • Erzurum, Turkey
    • Ataturk University Research Hospital
  • Istanbul, Turkey
    • Istanbul Haseki Training and Research Hospital
  • Istanbul, Turkey
    • Haydarpasa Numune Training and Research Hospital
  • Istanbul, Turkey
    • Başakşehir Çam and Sakura City Hospital
  • Istanbul, Turkey
    • Istanbul University Istanbul Faculty of Medicine
  • Istanbul, Turkey, 34786
    • Istanbul University Cerrahpasa Faculty of Medicine
  • Istanbul, Turkey
    • Bezmialem Vakif University Faculty of Medicine
  • Istanbul, Turkey
    • University of Health Sciences Bakırkoy Dr. Sadi Konuk Training and Research Hospital
  • Kayseri, Turkey, 38110
    • Erciyes University Faculty of Medicine
  • Konya, Turkey
    • Necmettin Erbakan University Meram Faculty of Medicine
  • Mersin, Turkey
    • Mersin University Faculty of Medicine
  • Samsun, Turkey
    • Samsun Ondokuz Mayis University Faculty of Medicine
  • Uşak, Turkey
    • Usak Training and Research Hospital
  • İzmir, Turkey
    • İzmir Democracy University Buca Seyfi Demirsoy Training And Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male and female patients between the ages of 18-65
2. Patients who can give their written informed consent prior to initiating any evaluation or procedure related to the study.
3. Patients with negative SARS-CoV-2 PCR test result
4. 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.
5. 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]
6. 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.]
7. Patients who received the last psoriasis treatment 4 weeks or before
8. 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.
9. Patients who can protect the lesion areas from ultraviolet (UV) rays (natural or artificial) during the study

10. 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.

11. Patients who can comply with all scheduled visits, laboratory tests, and other study procedures
12. Patients with normal adrenocorticotropic hormone (ACTH) stimulation test
13. Patients with normal dihydroepiandrostenedione sulfate (DHEAS) levels

Exclusion Criteria:

1. Patients with a known sensitivity/hypersensitivity to any component of the drugs to be used in the study
2. Pregnant or lactating or female patients with a positive pregnancy test
3. Patients who are resistant/unresponsive to corticosteroids
4. Patients with psoriasis (eg guttate, erythrodermic, exfoliative or pustular) that, in the opinion of the investigating physician, resolves spontaneously or rapidly worsens
5. 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
6. Patients who received phototherapy, photochemotherapy, systemic or local treatment for psoriasis or used systemic anti-inflammatory agents in the last 4 weeks
7. Patients who received biologic therapy for psoriasis in the last 3 months
8. Immunosuppressive or immunocompromised patients (patients who have taken immunosuppressive drugs in the last 2 months will also be excluded)
9. Patients who have received any cancer treatment in the last 1 year
10. Patients with severe hypertension (systolic blood pressure [SBP] > 160 mmHg or diastolic blood pressure [DBP] > 100 mmHg)
11. Patients who cannot comply with the study procedures/rules and cannot be in harmony with the research team
12. Patients who have participated in another clinical trial in the last 2 months or who are taking part in another clinical trial concurrently
13. Patients with a known abnormality of the hypothalamus-pituitary-adrenal axis (HPA axis)
14. Patients using products containing dihydroepiandrostenedione (DHEA) or dihydroepiandrostenedione sulfate (DHEAS) in the last 1 month

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GN-037 cream; 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.	Drug: GN-037; GN-037
Placebo Comparator: Placebo; 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.	Drug: Placebo; Placebo
Active Comparator: Clobetasol 17-propionate cream; 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.	Drug: Clobetasol 17-propionate; Clobetasol 17-propionate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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).	.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	56 days
Improvement in Dermatology Life Quality Index (DLQI)	Improvement in DLQI at weeks 4 and 8 compared to baseline.	28 days

Collaborators and Investigators

• Sponsor: GEN İlaç ve Sağlık Ürünleri A.Ş.
• Collaborators: Monitor CRO
• Investigators: Study Chair: Nadir Ulu, MD PhD, Gen Ilac

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2022
• Primary Completion (Actual): January 4, 2024
• Study Completion (Actual): March 3, 2024

Study Registration Dates

• First Submitted: January 10, 2023
• First Submitted That Met QC Criteria: January 23, 2023
• First Posted (Actual): January 31, 2023

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: local treatment; mild to moderate plaque psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Clobetasol
• Other Study ID Numbers: MON886.151.7

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No