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

NCT05706870 | Completed Phase 2

• 1 other identifier: MON886.151.7
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 18

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

Conditions

Psoriasis

Keywords

mild to moderate plaque psoriasis; local treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Mean change in %BSA affected from baseline at weeks 2, 4, 6 and 8 in each arm.

  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.

  28 days

• Mean change in in total plaque severity score (TPSS) from baseline at week 2, 4, 6 and 8 in each arm.

  28 days

• Improvement in target lesion healing from baseline at weeks 2, 4, 6 and 8 in each arm.

  .28 days

• Improvement in Dermatology Life Quality Index (DLQI)

  28 days

Study Arms (3)

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.

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.

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.

Drug: Placebo

Interventions

GN-037 DRUG

GN-037

GN-037 cream

Clobetasol 17-propionate DRUG

Clobetasol 17-propionate

Clobetasol 17-propionate cream

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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% \[Face, scalp, palms, soles, axillae, and intertriginous areas will be excluded from this assessment.\]
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GEN İlaç ve Sağlık Ürünleri A.Ş.: lead
• Monitor CRO: collaborator

Study Sites (18)

Ankara Etlik City Hospital

Ankara, Turkey (Türkiye)

Location

Balıkesir University Faculty of Medicine

Balıkesir, Turkey (Türkiye)

Location

Uludag University Faculty of Medicine

Bursa, Turkey (Türkiye)

Location

Pamukkale University Faculty of Medicine

Denizli, Turkey (Türkiye)

Location

Ataturk University Research Hospital

Erzurum, Turkey (Türkiye)

Location

Istanbul University Cerrahpasa Faculty of Medicine

Istanbul, 34786, Turkey (Türkiye)

Location

Basaksehir Cam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location

Bezmialem Vakif University Faculty of Medicine

Istanbul, Turkey (Türkiye)

Location

Haydarpasa Numune Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Istanbul Haseki Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Istanbul University Istanbul Faculty of Medicine

Istanbul, Turkey (Türkiye)

Location

University of Health Sciences Bakırkoy Dr. Sadi Konuk Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

İzmir Democracy University Buca Seyfi Demirsoy Training And Research Hospital

Izmir, Turkey (Türkiye)

Location

Erciyes University Faculty of Medicine

Kayseri, 38110, Turkey (Türkiye)

Location

Necmettin Erbakan University Meram Faculty of Medicine

Konya, Turkey (Türkiye)

Location

Mersin University Faculty of Medicine

Mersin, Turkey (Türkiye)

Location

Samsun Ondokuz Mayis University Faculty of Medicine

Samsun, Turkey (Türkiye)

Location

Uşak Training and Research Hospital

Uşak, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 39578347 DERIVED

• Sezer 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.

  PMID: 37300792 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

Clobetasol

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Nadir Ulu, MD PhD

  Gen Ilac

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 31, 2023
• Study Start: December 7, 2022
• Primary Completion: January 4, 2024
• Study Completion: March 3, 2024
• Last Updated: July 16, 2025

Record last verified: 2024-03

Locations

TU (18)