Post-authorization Safety Study on the Long Term Safety of Sonidegib in Patients With Locally Advanced Cell Carcinoma (NISSO)

March 17, 2026 updated by: Sun Pharmaceutical Industries Limited

A Non-interventional, Multi-national, Multi-center Post-authorization Safety Study (PASS) to Assess the Long Term Safety and Tolerability of Odomzo (Sonidegib) Administered in Patients With Locally Advanced Cell Carcinoma (laBCC)

Collect real world safety data on the use of sonidegib in adult patients with laBCC. Document major safety parameters such as on treatment deaths, adverse events (AEs)/ serious adverse events (SAEs) and discontinuation secondary to AEs.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a non-interventional, multinational, multi-center post-authorization safety study (PASS), to assess the safety of sonidegib administered in routine clinical practice in patients with laBCC who are not amendable to curative surgery or radiation therapy. This study is observational in nature and does not impose a therapy protocol, diagnostic/therapeutic interventions or a specific visit schedule. For this study, each enrolled patient will be followed up for 3 years after enrollment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
323

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Bochum, Germany
        • Katholisches Klinikum Bochum St. Josef-Hospital
      • Buxtehude, Germany
        • Elbe Kliniken Stade - Buxtehude GmbH
      • Darmstadt, Germany, 64297
        • Klinikum Darmstadt GmbH
      • Dresden, Germany, 1307
        • Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden
      • Erfurt, Germany, 99089
        • Helios Klinikum
      • Essen, Germany
        • Universitaetsklinikum Essen
      • Freiburg im Breisgau, Germany, 79104
        • Universitätsklinikum Freiburg
      • Gera, Germany, 07548
        • SRH Wald-Klinikum
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf
      • Hanover, Germany, '30625
        • Medizinische Hochschule Hannover
      • Kiel, Germany
        • Universitaets-Hautklinik Kiel
      • Ludwigshafen, Germany
        • Klinikum Ludwigshafen gGmbH
      • Lübeck, Germany
        • Universitaetsklinikum Schleswig-Holstein
      • Magdeburg, Germany, 39120
        • Universitätsklinik Magdeburg
      • Minden, Germany, 32429
        • Johannes Wesling Klinikum Minden
      • München, Germany, 80802
        • Klinikum Rechts der Isar
      • Münster, Germany, 48157
        • Fachklinik Muenster-Hornheide
      • Oberhausen, Germany, 46045
        • Helios St. Elisabeth Klinik
      • Quedlinburg, Germany, 06484
        • Harzklinikum Dorothea Christiane Erxleben GmbH
      • Regensburg, Germany, 93053
        • Universitätsklinikum Regensburg
      • Tübingen, Germany
        • Universitaetsklinikum Tuebingen
      • Ulm, Germany, 89081
        • Universitätsklinikum Ulm
  • Italy
      • Bari, Italy
        • I.R.C.C.S Istituto Tumori "Giovanni Paolo II"
      • Brescia, Italy
        • Asst Spedali Civili Di Brescia
      • Florence, Italy
        • Azienda Toscana Centro - Università di Firenze
      • Genova, Italy, 16132
        • Ospedale Policlinico San Martino
      • L’Aquila, Italy
        • ASL1 Avezzano-Sulmona-L'Aquila
      • Meldola, Italy, 47014
        • Ist. Scien. Romagnolo per lo Studio e la Cura dei Tumori - IRST
      • Milan, Italy, 20133
        • Forndazione I.R.C.C.S. Istituto nazionale dei tumori
      • Napoli, Italy
        • Università Degli Studi Di Napoli Federico Ii
      • Napoli, Italy, 80131
        • Istituto Tumori Napoli Fondazione G. Pascale
      • Novara, Italy
        • AOU Maggiore della Carità - Università del Piemonte Orientale
      • Roma, Italy, 00168
        • Universita Cattolica del Sacro Cuore
      • Roma, Italy, 00167
        • IDI
  • Spain
      • Badalona, Spain, 8916
        • Hospital Germans Trias i Pujol
      • Barcelona, Spain, 8036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 8041
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain, 8035
        • Hospital Vall d'Hebron
      • Las Palmas de Gran Canaria, Spain, 35010
        • Hospital Universitario de Gran Canaria Doctor Negrín
      • Madrid, Spain, 28034
        • Hospital Universitario Ramón y Cajal
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Pontevedra, Spain, 36001
        • Complejo Hospitalario Universitario de Pontevedra
      • Santa Cruz de Tenerife, Spain, 38010
        • Hospital Universitario Nuestra Señora de Candelaria
      • Valencia, Spain, 46026
        • Hospital Universitario la Fe
      • Valencia, Spain, 46014
        • Hospital General Universitari València
  • Switzerland
      • Bern, Switzerland
        • Inselspital
      • Zurich, Switzerland, CH- 8091
        • UniversitätsSpital Zürich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with laBCC undergoing treatment with sonidegib.

Description

Inclusion Criteria:

  • Written informed consent or equivalent document (e.g., written information) as per country regulation
  • Patients aged 18 years or older with a diagnosis of laBCC who are not amenable to curative surgery or radiation therapy
  • Patients must be treated with sonidegib 200 mg orally taken once daily (dose modifications according to the approved local country prescribing information are permitted)
  • Sonidegib treatment must be started either at the first visit for this study or prior to study entry.

Exclusion Criteria:

  • Patients treated with any hedgehog pathway inhibitor besides sonidegib within 3 months prior to study entry
  • Patients currently enrolled in an interventional clinical trial
  • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the Summary of Product Characteristics (SmPC)
  • Pregnancy and breast-feeding
  • Women of childbearing potential who do not comply with the Odomzo Pregnancy Prevention Programme (as defined in sections 4.4 and 4.6 of the approved SmPC).
  • Male patients who are unable to follow or comply with the required contraception measures (as defined in sections 4.4 and 4.6 of the approved SmPC).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sonidegib
Patients with laBCC undergoing sonidegib treatment in routine clinical practice
Drug: sonidegib
Sonidegib 200 mg orally taken once daily (dose modifications according to the approved local country prescribing information are permitted)
Other Names:
  • LDE225

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of patients with AEs/SAEs
Time Frame: 3 years
including on-treatment deaths and discontinuation due to AEs/SAEs
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of patients with AEs of special interest (AESI) or populations
Time Frame: 3 years
in patients with: relevant polymorphism, ≥65 yrs, hepatic or renal impairment, female patients with child bearing potential using anticonceptives, anemia (hemoglobin <9 g/dL), recent myocardial ischemia or cardiac failure, concomitant medications with known risk of creatine kinase elevation
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Pharmaceutical Industries Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ralf Gutzmer, Universitätsklinik für Dermatologie, Venerologie, Allergologie und Phlebologie Johannes Wesling Klinikum Minden Mühlenkreiskliniken Universitätsklinikum der Ruhr-Universität Bochum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 11, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 14, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 14, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLDE225A2404

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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