Efficacy and Safety Evaluation of 0.1% Mometasone Furoate Cutaneous Emulsion Versus Ecural Fat Cream and Vehicle in Adult Plaque Psoriasis
- Trial ID
- 2024-511583-82-00
- Protocol
- 410701BS
- Sponsor
- GALENpharma GmbH
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this phase III, multicentre, randomised, observer-blind, intraindividual, paired, comparative trial is to evaluate the **efficacy** of a 0.1% mometasone furoate cutaneous emulsion in the treatment of adult participants with chronic stable plaque psoriasis. The study aims to demonstrate that the test product is non-inferior to the comparator product, Ecural® fat cream, by assessing the mean percentage change in the Total Sign Score (TSS), which includes erythema, induration, and scaling. Additionally, the trial seeks to establish the superiority of the test product over the vehicle cutaneous emulsion, again using the mean percentage change in TSS as the primary endpoint. These objectives are clinically relevant as they aim to confirm the therapeutic potential of the test product in managing plaque psoriasis, a chronic inflammatory skin condition characterized by red, scaly patches.
Secondary objectives include assessing the **safety** of the test product compared to the comparator and vehicle. This evaluation is crucial to ensure that the test product not only provides therapeutic benefits but also maintains an acceptable safety profile for patients with plaque psoriasis.
Participants
The clinical trial involves **participants** diagnosed with **plaque psoriasis**, specifically targeting individuals with a confirmed clinical diagnosis of stable plaque (or vulgaris) psoriasis. The study population comprises both males and non-pregnant, non-lactating females aged between 18 to 65 years. Participants are required to have mild psoriasis at screening, characterized by a Body Surface Area (BSA) of 10% or less, a Psoriasis Area and Severity Index (PASI) of 10 or less, and a Dermatology Life Quality Index (DLQI) of 10 or less. The trial does not include a vulnerable population. Participants must have two comparable psoriatic areas for treatment on the extremities or trunk, with specific size and location criteria. The trial includes individuals with a baseline Total Sign Score (TSS) of at least 6 out of 9 for each selected area. Female participants of childbearing potential must be permanently sterile or agree to use a highly effective birth control method throughout the trial. The sponsor has not provided information regarding the total number of participants. The selection process ensures that participants meet the inclusion criteria, and written informed consent is obtained from all participants.
Plans and Procedures
The clinical trial is a **randomized**, observer-blind, intraindividual, paired, comparative study designed to evaluate the efficacy and safety of a 0.1% **mometasone furoate** cutaneous emulsion in comparison to ECURAL® fat cream and a placebo vehicle in the treatment of adult participants with plaque psoriasis. The trial is categorized as a Phase III therapeutic confirmatory study, aiming to demonstrate the non-inferiority of the test product to the comparator and its superiority over the placebo. The trial is expected to commence recruitment on August 6, 2024, and conclude by January 14, 2025.
Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as age, diagnosis of stable plaque psoriasis, and baseline Total Sign Score (TSS). The trial will involve multiple follow-up visits, including assessments on Day 8 and Day 22, to evaluate changes in TSS, which measures erythema, induration, and scaling. The primary efficacy endpoint is the percentage change from baseline in TSS on Day 22, while secondary endpoints include changes in TSS on Days 8 and 22.
The expected duration of participant involvement is approximately three weeks, with the treatment period limited to a maximum of three weeks. Conditions that may lead to early termination from the study include non-compliance with the study protocol, adverse events, or withdrawal of consent. Participants will be monitored for safety and efficacy throughout the trial, with the end-of-study visit marking the completion of their participation. The trial is designed to ensure rigorous assessment of the test product's therapeutic potential in a controlled and scientifically robust manner.
Treatment
The clinical trial involves the use of **MomeGalen 1 mg/g cutaneous emulsion** as the experimental medication. This formulation contains the active ingredient **mometasone furoate**, a potent corticosteroid, and is presented as a cutaneous emulsion. The medication is administered topically, with a maximum daily dose of 0.5 mg and a total maximum dose of 10.5 mg over a treatment period of up to 3 weeks. The emulsion is applied directly to the affected skin areas, and participant compliance is monitored through regular assessments and documentation of application frequency and dosage.
The study also includes a **placebo** treatment, which is an active ingredient-free vehicle of the mometasone cutaneous emulsion. This placebo is used to evaluate the efficacy of the experimental medication by serving as a control. The placebo is applied in the same manner as the experimental treatment, ensuring that any observed effects can be attributed to the active ingredient rather than the emulsion base.
Additionally, the trial employs **ECURAL Fettcreme, 1 mg/g Creme** as a comparator treatment. This cream contains **mometasone furoate Ph. Eur.** and is also administered topically. The dosing regimen mirrors that of the experimental medication, with a maximum daily dose of 0.5 mg and a total maximum dose of 10.5 mg over a 3-week period. The comparator serves to establish the non-inferiority of the experimental treatment in managing chronic stable plaque-type psoriasis. Compliance with the comparator treatment is similarly monitored to ensure accurate and reliable data collection.
Efficacy
The efficacy of the clinical trial will be assessed by evaluating the **Total Sign Score (TSS)**, which is the sum score for erythema, induration, and scaling in patients with stable plaque psoriasis. The primary efficacy endpoint is the percentage change from baseline in TSS on Day 22. This change is calculated using the formula: % change = 100 * ((TSS on Day 22 - TSS on Day 1) / TSS on Day 1). Secondary efficacy endpoints include the percentage change from baseline in TSS on Day 8, as well as changes from baseline in TSS on both Days 8 and 22.
The trial is designed to demonstrate that the test product, a 0.1% mometasone furoate cutaneous emulsion, is non-inferior to the comparator product, ECURAL® fat cream, and superior to the vehicle emulsion. Efficacy assessments will be conducted at specified time points, namely Days 8 and 22, to monitor the progression and response to treatment. The trial aims to provide a comprehensive evaluation of the therapeutic effects of the test product compared to the active comparator and the vehicle in adult patients with stable plaque psoriasis.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Males and non-pregnant, non-lactating females aged 18 to 65 years.
- Subjects with a confirmed clinical diagnosis of stable plaque (or vulgaris) psoriasis. Severity should be mild at screening, defined as having affected BSA ≤10%, a PASI ≤10, and a Dermatology Life Quality Index (DLQI) ≤10
- Subjects must have 2 comparable psoriatic areas for treatment on the extremities or trunk (either symmetrical bilateral, e.g., elbow left and elbow right, or both on one body part if at least 3 cm apart, e.g., upper back and lower back) between 20 and 200 cm2. The larger lesion should not be larger than approximately twice the size of the smaller lesion. Psoriatic lesions on the face and scalp, neck, palms, and soles as well as in intertriginous regions may not be selected as treatment areas.
- Subjects with a comparable baseline TSS (sum score for erythema, induration, and scaling) of at least 6 of 9 for each of the selected areas (not more than 2 grades difference in TSS between the 2 target lesions).
- Female volunteers of childbearing potential must either be permanently sterile or agree to use a highly effective birth control method (failure rate ˂1% per year when used consistently and correctly) throughout the clinical trial.
- Written informed consent obtained.
Exclusion Criteria
- Pregnant or breastfeeding women.
- Systemic therapies for the treatment of psoriasis including but not limited to cyclosporine, retinoids, methotrexate, tacrolimus, azathioprine, salazosulfapyridine, apremilast, and glucocorticoids less than 4 weeks prior to randomisation.
- Use of biologic agents for the treatment of psoriasis prior to randomisation as follows: Prohibited medication: Adalimumab, infliximab, brodalumab, ixekizumab, etanercept, guselkumab, certolizumab pegol, golimumab (wash-out period: 3 months); Ustekinumab, alefacept, secukinumab (wash-out period: 6 months); Rituximab (wash-out period: 12 months).
- Systemic treatment with any other biological treatments (anti-tumour necrosis factor/interleukin [IL]-12/IL-23 and IL-17 or any other monoclonal antibodies [mAbs]) within the period of 5 half-lives of the biological before first treatment and during the clinical trial.
- Systemic treatment with janus kinase (JAK) or tyrosine kinase 2 (TYK2) inhibitors within 3 months prior to randomisation.
- Treatment with systemic or locally acting medications which might counter or influence the aim of the clinical trial (medications which are known to provoke or aggravate psoriasis, e.g., antimalarial drugs, lithium) within 8 weeks before first treatment and/or during the clinical trial. Beta-blockers or angiotensin converting enzyme (ACE) inhibitors are allowed if on a stable dose for 3 months before clinical trial medication initiation.
- Use of another IP or participation in the treatment phase of a clinical trial within the last 4 weeks prior to first dose or 5 half-life periods if known to be longer.
- Clinically relevant history or presence of any disease or any chronic medical condition which is not well controlled or surgical history which may interfere with the conduct of the clinical trial in the opinion of the investigator.
- Other active skin diseases (e.g., urticaria, atopic dermatitis), skin infections (bacterial, fungal, parasitic, or viral) or skin conditions that might interfere in the opinion of the investigator with treatment and evaluation of psoriasis.
- Acute psoriasis guttata, psoriasis punctata as well as erythrodermic, exfoliative and pustular psoriasis.
- Findings determined in physical examination and/or vital signs which are considered clinically significant in the opinion of the investigator.
- History of an allergic reaction or significant sensitivity to constituents of IPs.
- Contraindications according to the SmPC of the comparator Ecural® fat cream. Of particular note, subjects with a hypersensitivity against soy or peanut should not participate in the clinical trial.
- Use of topical therapies for the treatment of psoriasis including but not limited to corticosteroids, vitamin D analogues, retinoids during the clinical trial or having discontinued less than 4 weeks prior to randomisation, and (specific to target plaques only) use of urea, salicylic acid, coal tar, and anthralin during the clinical trial or having discontinued less than 2 weeks prior to randomisation.
- Phototherapy for the treatment of psoriasis including but not limited to: UV-A, UV-B, sunbaths less than 4 weeks, and psoralen and UV-A (PUVA) less than 8 weeks prior to randomisation.
- History of alcohol or other substance abuse within the last year.
- In the opinion of the investigator performing the initial examination the subject should not participate in the clinical trial, e.g., due to probable noncompliance or inability to understand nature, meaning, and consequences of the clinical trial and give adequately informed consent.
- Close affiliation with the investigator (e.g., a close relative) or subject is an employee of sponsor, contract research organisation (CRO) or clinical trial centres.
- Subject is institutionalised because of legal or regulatory order.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Poland | Not Recruiting | 06 Aug 2024 | 99 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
MomeGalen 1 mg/g cutaneous emulsion | Test | CUTANEOUS EMULSION | TOPICAL ADMINISTRATION | 0.5 | 3 | PRD11178414 |
Placebo to 0.1% mometasone furoate cutaneous emulsionactive ingredient-free vehicle of mometasone cutaneous emulsion | Placebo | N/A | — | — | — | N/A |
ECURAL Fettcreme, 1 mg/g Creme | Comparator | CREME | TOPICAL ADMINISTRATION | 0.5 | 3 | PRD8791410 |