Evaluation of efficacy and safety of 0.1% mometasone furoate cutaneous emulsion compared to its active ingredient-free base and a comparator product

Overview

Sponsor-declared trial summary

Key facts

Sponsor

GALENpharma GmbH

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

8 Oct 2024 → 3 Mar 2025

Decision date (initial)

2024-08-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

1) To demonstrate that topical treatment with the test product (T, IP 1) is non-inferior to the comparator product (C, IP 2) in the treatment of chronic stable plaque-type psoriasis as determined by mean % change in Total Sign Score (TSS, sum score for erythema, induration, and scaling).
2) To demonstrate the superiority of T to the vehicle (V, IP 3) as determined by mean % change in TSS.

Secondary objectives 1

1. To assess the safety of T compared to C and V.

Conditions and MedDRA coding

Plaque psoriasis

Study design 1 period

Regulatory references

Scientific advice from competent authorities

Swedish Medical Products Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Males and non-pregnant, non-lactating females aged 18 to 65 years.
2. 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
3. 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.
4. 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).
5. 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.
6. Written informed consent obtained.

Exclusion criteria 19

1. Pregnant or breastfeeding women.
2. 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.
3. 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).
4. 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.
5. Systemic treatment with janus kinase (JAK) or tyrosine kinase 2 (TYK2) inhibitors within 3 months prior to randomisation.
6. 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.
7. 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.
8. 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.
9. 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.
10. Acute psoriasis guttata, psoriasis punctata as well as erythrodermic, exfoliative and pustular psoriasis.
11. Findings determined in physical examination and/or vital signs which are considered clinically significant in the opinion of the investigator.
12. History of an allergic reaction or significant sensitivity to constituents of IPs.
13. 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.
14. 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.
15. 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.
16. History of alcohol or other substance abuse within the last year.
17. 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.
18. 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.
19. Subject is institutionalised because of legal or regulatory order.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Primary efficacy endpoint: % change from baseline in TSS on Day 22. Change from baseline in percent (%) is calculated as: % change=100*((TSS 22 - TSS 1) / TSS 1)

Secondary endpoints 2

1. Secondary efficacy endpoints: % change from baseline in TSS on Day 8.
2. Secondary efficacy endpoints: Changes from baseline in TSS on Days 8 and 22.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

GALENpharma GmbH

Sponsor organisation

GALENpharma GmbH

Address

Wittland 13, Hasseldieksdamm Hasseldieksdamm

City

Kiel

Postcode

24109

Country

Germany

Scientific contact point

Organisation

GALENpharma GmbH

Contact name

Head of medical information

Public contact point

Organisation

GALENpharma GmbH

Contact name

Head of medical information

Third parties 2

Locations

1 EU/EEA country · 8 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications