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

Last updated: March 29, 2024
Sponsor: GEN İlaç ve Sağlık Ürünleri A.Ş.
Overall Status: Completed

Phase

2

Condition

Warts

Scalp Disorders

Rosacea

Treatment

Clobetasol 17-propionate

GN-037

Placebo

Clinical Study ID

NCT05706870
MON886.151.7
  • Ages 18-65
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 anyevaluation 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 monthsago by a dermatologist and whose diagnosis was confirmed according to the clinicaljudgment of the research physician at the time of enrolment.
  5. Patients with a Investigator Global Assessment (IGA) score of 2 or 3 at the screeningvisit [Face, scalp, palms, soles, armpits, and intertriginous areas will be excludedfrom 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 beexcluded 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 examinationand who do not have any clinically significant disease/condition other than plaquepsoriasis that, at the discretion of the investigator, could affect the studyevaluation.
  9. Patients who can protect the lesion areas from ultraviolet (UV) rays (natural orartificial) 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 aneffective method of contraception until the end of the study. Male patients: Patients who agreed to use an effective method of contraception for theduration of the study.
  11. Patients who can comply with all scheduled visits, laboratory tests, and other studyprocedures
  12. Patients with normal adrenocorticotropic hormone (ACTH) stimulation test
  13. Patients with normal dihydroepiandrostenedione sulfate (DHEAS) levels

Exclusion

Exclusion Criteria:

  1. Patients with a known sensitivity/hypersensitivity to any component of the drugs to beused 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, inthe opinion of the investigating physician, resolves spontaneously or rapidly worsens
  5. Patients with other inflammatory skin disease (eg, atopic dermatitis, contactdermatitis, eczema, tinea corporis) that, in the opinion of the investigativephysician, may affect study evaluations at the targeted treatment sites
  6. Patients who received phototherapy, photochemotherapy, systemic or local treatment forpsoriasis 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 takenimmunosuppressive 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 ordiastolic blood pressure [DBP] > 100 mmHg)
  11. Patients who cannot comply with the study procedures/rules and cannot be in harmonywith the research team
  12. Patients who have participated in another clinical trial in the last 2 months or whoare taking part in another clinical trial concurrently
  13. Patients with a known abnormality of the hypothalamus-pituitary-adrenal axis (HPAaxis)
  14. Patients using products containing dihydroepiandrostenedione (DHEA) ordihydroepiandrostenedione sulfate (DHEAS) in the last 1 month

Study Design

Total Participants: 190
Treatment Group(s): 3
Primary Treatment: Clobetasol 17-propionate
Phase: 2
Study Start date:
December 07, 2022
Estimated Completion Date:
March 03, 2024

Study 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.

Connect with a study center

  • Ankara Etlik City Hospital

    Ankara,
    Turkey

    Site Not Available

  • Balıkesir University Faculty of Medicine

    Balıkesir,
    Turkey

    Site Not Available

  • Balıkesir University Health Practice and Research Hospital

    Balıkesir,
    Turkey

    Site Not Available

  • Uludag University Faculty of Medicine

    Bursa,
    Turkey

    Site Not Available

  • Pamukkale University Faculty of Medicine

    Denizli,
    Turkey

    Site Not Available

  • Pamukkale University Faculty of Medicine Hospital

    Denizli,
    Turkey

    Site Not Available

  • Ataturk University Research Hospital

    Erzurum,
    Turkey

    Site Not Available

  • Hatay Mustafa Kemal University Faculty of Medicine Hospital

    Hatay,
    Turkey

    Site Not Available

  • Basaksehir Cam and Sakura City Hospital

    Istanbul,
    Turkey

    Site Not Available

  • Bezmialem Vakif University Faculty of Medicine

    Istanbul,
    Turkey

    Site Not Available

  • Haydarpasa Numune Training and Research Hospital

    Istanbul,
    Turkey

    Site Not Available

  • Istanbul Haseki Training and Research Hospital

    Istanbul,
    Turkey

    Site Not Available

  • Istanbul Umraniye Training and Research Hospital

    Istanbul,
    Turkey

    Active - Recruiting

  • Istanbul University Cerrahpasa Faculty of Medicine

    Istanbul, 34786
    Turkey

    Site Not Available

  • Istanbul University Istanbul Faculty of Medicine

    Istanbul,
    Turkey

    Site Not Available

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

    Istanbul,
    Turkey

    Site Not Available

  • Erciyes University Faculty of Medicine

    Kayseri, 38110
    Turkey

    Site Not Available

  • Necmettin Erbakan University Meram Faculty of Medicine

    Konya,
    Turkey

    Site Not Available

  • Necmettin Erbakan University Meram Faculty of Medicine Hospital

    Konya,
    Turkey

    Site Not Available

  • Mersin University Faculty of Medicine

    Mersin,
    Turkey

    Site Not Available

  • Mersin University Hospital

    Mersin,
    Turkey

    Site Not Available

  • Samsun Ondokuz Mayis University Faculty of Medicine

    Samsun,
    Turkey

    Site Not Available

  • Uşak Training and Research Hospital

    Uşak,
    Turkey

    Site Not Available

  • İzmir Democracy University Buca Seyfi Demirsoy Training And Research Hospital

    İzmir,
    Turkey

    Site Not Available

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