Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Ongoing, recruiting
Participants planned
55
Countries
1
Sites
1
Superficial Basal cell carcinoma
Evaluate the efficacy of Tirbanibulin (Klisyri®) in the treatment of BCCs.
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Nice
- 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
- 17 Nov 2023 → ongoing
- Decision date (initial)
- 2023-10-05
- 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: Therapy
Evaluate the efficacy of Tirbanibulin (Klisyri®) in the treatment of BCCs.
Secondary objectives 4
- To assess the tolerability of Tirbanibulin (Klisyri®) in the treatment of BCCs.
- Evaluate the efficacy of Tirbanibulin (Klisyri®) after 1, 2, 3, or 4 cycles of BCC treatment.
- Assess the thickness of BCCs.
- Evaluating patient satisfaction.
Conditions and MedDRA coding
Superficial Basal cell carcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10004146 | Basal cell carcinoma | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Male and female patients over 18 years of age.
- Patients with one or more primary, superficial BCCs of the trunk or limbs confirmed by LC-OCT.
- Primitive BCC, long axis less than or equal to 15 mm.
- Patient affiliated to a Social Security scheme.
- Patient likely to understand study instructions.
- Signed informed consent. If necessary, a legal representative can sign the consent form.
Exclusion criteria 9
- BCC scalp and face
- Recurrent BCC
- Non-superficial BCC
- BCC diameter > 15 mm
- Patient allergic to Tirbanibulin to an excipient of the finished product
- Treatment with cryotherapy, imiquimod, PDT, or radiotherapy in the treatment area within 6 months prior to the first visit
- Pregnant or breast-feeding women (a urine pregnancy test will be performed)
- Current participation or less than 30 days' participation in a clinical drug trial
- Any medical or psychiatric condition that could prevent the proper understanding and conduct of treatment and study (adults under guardianship)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Complete remission (CR) of BCC at the end of treatment. CR is defined as the absence of evidence of BCC clinically and on LC-OCT.
Secondary endpoints 4
- Type, frequency, severity and time of onset of side effects. Side effects will be classified into grades based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) scale. The intensity of short-term local side effects will be assessed using the LSR score.
- Complete remission of BCCs after 1, 2, 3, or 4 cycles of treatment.
- LC-OCT measurement of BCC thickness.
- TSQM9 score.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD9190093 · Product
- Active substance
- Tirbanibulin
- Pharmaceutical form
- OINTMENT
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 2 cm2 square centimeter
- Max total dose
- 25 cm2 square centimeter
- Max treatment duration
- 20 Day(s)
- Authorisation status
- Authorised
- ATC code
- D06BX03 — -
- Marketing authorisation
- EU/1/21/1558/001
- MA holder
- ALMIRALL, S.A.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Nice
- Sponsor organisation
- Centre Hospitalier Universitaire De Nice
- Address
- 151 Route De Saint Antoine
- City
- Nice
- Postcode
- 06200
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Nice
- Contact name
- Pr Philippe Bahadoran
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Nice
- Contact name
- Mme Cynthia CAILLON
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 55 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2023-11-17 | 2024-02-16 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 15 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_PROTOCOL_2023-505971-66-00 | 3 |
| Protocol (for publication) | D4_PATIENT FACING DOCUMENT_2023-505971-66-00 | 0.2 |
| Recruitment arrangements (for publication) | 2023-505971-66-00_ADDITIONNEL_20230510_TIRBASO_FP | 0 |
| Recruitment arrangements (for publication) | 2023-505971-66-00_ADDITIONNEL_20230510_TIRBASO_NFP | 0 |
| Recruitment arrangements (for publication) | RECRUTEMENT ARRANGEMENTS | 0 |
| Subject information and informed consent form (for publication) | 2023-505971-66-00_CARTE PATIENT_TIRBASO | 0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Patient_FP | 3 |
| Subject information and informed consent form (for publication) | SIS and ICF Patient_NFP | 0.1 |
| Subject information and informed consent form (for publication) | SIS and ICP Patient Droit a image FP | 0.0 |
| Summary of Product Characteristics (SmPC) (for publication) | RCP_TIRBANIBULINE | 0 |
| Summary of Product Characteristics (SmPC) (for publication) | RCP_TIRBANIBULINE | 0 |
| Synopsis of the protocol (for publication) | 2023-505971-66-00_RESUME_v0-1_20230810_TIRBASO | 0-1 |
| Synopsis of the protocol (for publication) | 2023-505971-66-00_RESUME_v0-1_SMA_20230810_TIRBASO | 0-1 |
| Synopsis of the protocol (for publication) | RESUME_2023-505971-66 | 3 |
| Synopsis of the protocol (for publication) | RESUME_PROFANE_2023-505971-66-00 | 0 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-04 | France | Acceptable 2023-10-02
|
2023-10-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-10-24 | France | Acceptable 2024-01-18
|
2024-01-18 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-07-08 | France | Acceptable 2024-08-12
|
2024-09-03 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-03-14 | France | Acceptable 2025-04-14
|
2025-04-14 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-06-12 | France | Acceptable 2025-07-08
|
2025-07-17 |