Clinical trial NCT05706870: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Keywords: mild to moderate plaque psoriasis
local treatment
Lead sponsor: GEN İlaç ve Sağlık Ürünleri A.Ş.
Sponsor class: INDUSTRY
Collaborators: name: Monitor CRO
First posted: 2023-01-31
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Improvement in Investigator Global Assessment (IGA) score evaluated at weeks 2, 4, 6 and 8 in each arm.
timeFrame: 28 days
Secondary outcomes:
measure: Mean change in %BSA affected from baseline at weeks 2, 4, 6 and 8 in each arm.
timeFrame: 28 days
measure: 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.
timeFrame: 28 days
measure: Mean change in in total plaque severity score (TPSS) from baseline at week 2, 4, 6 and 8 in each arm.
timeFrame: 28 days
measure: Improvement in target lesion healing from baseline at weeks 2, 4, 6 and 8 in each arm.
timeFrame: .28 days
measure: Improvement in Dermatology Life Quality Index (DLQI)
timeFrame: 28 days
measure: Safety, Adverse Events and Serious Adverse Events
timeFrame: 56 days
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
city: Balıkesir
country: Turkey
facility: Balıkesir University Faculty of Medicine
city: Bursa
country: Turkey
facility: Uludag University Faculty of Medicine
city: Denizli
country: Turkey
facility: Pamukkale University Faculty of Medicine
city: Erzurum
country: Turkey
facility: Ataturk University Research Hospital
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Faculty of Medicine
city: Istanbul
country: Turkey
facility: Basaksehir Cam and Sakura City Hospital
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University Faculty of Medicine
city: Istanbul
country: Turkey
facility: Haydarpasa Numune Training and Research Hospital
city: Istanbul
country: Turkey
facility: Istanbul Haseki Training and Research Hospital
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Faculty of Medicine
city: Istanbul
country: Turkey
facility: University of Health Sciences Bakırkoy Dr. Sadi Konuk Training and Research Hospital
city: İzmir
country: Turkey
facility: İzmir Democracy University Buca Seyfi Demirsoy Training And Research Hospital
city: Kayseri
country: Turkey
facility: Erciyes University Faculty of Medicine
city: Konya
country: Turkey
facility: Necmettin Erbakan University Meram Faculty of Medicine
city: Mersin
country: Turkey
facility: Mersin University Faculty of Medicine
city: Samsun
country: Turkey
facility: Samsun Ondokuz Mayis University Faculty of Medicine
city: Uşak
country: Turkey
facility: Uşak Training and Research Hospital
Study officials:
affiliation: Gen Ilac
name: Nadir Ulu, MD PhD
role: STUDY_CHAIR
References: