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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05706870
• Other study ID #: MON886.151.7
• Status: Completed
• Phase: Phase 2
• Start date: December 7, 2022
• Est. completion date: March 3, 2024

Study information

• Verified date: March 2024
• Source: GEN Ilaç ve Saglik Ürünleri A.S.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: March 3, 2024
• Est. primary completion date: January 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• GN-037
GN-037
• Clobetasol 17-propionate
Clobetasol 17-propionate
• Placebo
Placebo

Locations

Country	Name	City	State
Turkey	Ankara Etlik City Hospital	Ankara
Turkey	Balikesir University Faculty of Medicine	Balikesir
Turkey	Uludag University Faculty of Medicine	Bursa
Turkey	Pamukkale University Faculty of Medicine	Denizli
Turkey	Ataturk University Research Hospital	Erzurum
Turkey	Basaksehir Cam and Sakura City Hospital	Istanbul
Turkey	Bezmialem Vakif University Faculty of Medicine	Istanbul
Turkey	Haydarpasa Numune Training and Research Hospital	Istanbul
Turkey	Istanbul Haseki Training and Research Hospital	Istanbul
Turkey	Istanbul University Cerrahpasa Faculty of Medicine	Istanbul
Turkey	Istanbul University Istanbul Faculty of Medicine	Istanbul
Turkey	University of Health Sciences Bakirkoy Dr. Sadi Konuk Training and Research Hospital	Istanbul
Turkey	Izmir Democracy University Buca Seyfi Demirsoy Training And Research Hospital	Izmir
Turkey	Erciyes University Faculty of Medicine	Kayseri
Turkey	Necmettin Erbakan University Meram Faculty of Medicine	Konya
Turkey	Mersin University Faculty of Medicine	Mersin
Turkey	Samsun Ondokuz Mayis University Faculty of Medicine	Samsun
Turkey	Usak Training and Research Hospital	Usak

Sponsors (2)

Lead Sponsor	Collaborator
GEN Ilaç ve Saglik Ürünleri A.S.	Monitor CRO

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Improvement in Dermatology Life Quality Index (DLQI)	Improvement in DLQI at weeks 4 and 8 compared to baseline.	28 days
Secondary	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