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

Gen İlaç

Status and phase: Completed; Phase 2

Conditions: Psoriasis

Treatments: Drug: Placebo; Drug: Clobetasol 17-propionate; Drug: GN-037

Study type: Interventional

Funder types: Industry

Identifiers

NCT05706870

MON886.151.7

Details and patient eligibility

About

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

Full 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.

Enrollment: 190 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

190 participants in 3 patient groups, including a placebo group

GN-037 cream

Experimental group

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.

Treatment:

Drug: GN-037

Clobetasol 17-propionate cream

Active Comparator group

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.

Treatment:

Drug: Clobetasol 17-propionate

Placebo

Placebo Comparator group

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.

Treatment:

Drug: Placebo