Clinical trial • Phase II/III • Immunology|Rare Disease

Etanercept for SAPHO syndrome

Phase II/III trial of Etanercept for SAPHO syndrome.

Overview

Trial Therapeutic Area
Immunology|Rare Disease
Trial Disease
SAPHO syndrome
Trial Stage
Phase II/III
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
10-09-2024
First CTIS Authorization Date
31-10-2024

Trial design

Randomised, placebo: water for injections (placebo), route: subcutaneous use; product record lists maximum dose 2 ml (doseuom ml).-controlled Phase II/III trial across 3 sites in Poland.

Randomised
Yes
Comparator
Placebo: Water for Injections (placebo), route: subcutaneous use; product record lists maximum dose 2 ml (doseUom ml).
Target Sample Size
60

Eligibility

Recruits 60 The trial record indicates a vulnerable population was selected. Participation requires the participant to express informed consent ("Expressing informed consent to participate in the study"). All participants must be age >18 so no parental consent/assent procedures for minors are applicable. Subject information and informed consent documents are included in the trial documents (examples: "L1_1_ICF_ z_Informacja_dla_ pacjenta_SAPHO_ver1-1_final", "L1_4_Formularz Ankiety Uczestnika Badania_final", "L1_5_Formularz Swiadomej Zgody na Biobankowanie_final"); available materials are in Polish based on document titles/translations..

Pregnancy Exclusion
Pregnancy, breastfeeding, inability to use effective contraception during the examination.
Vulnerable Population
The trial record indicates a vulnerable population was selected. Participation requires the participant to express informed consent ("Expressing informed consent to participate in the study"). All participants must be age >18 so no parental consent/assent procedures for minors are applicable. Subject information and informed consent documents are included in the trial documents (examples: "L1_1_ICF_ z_Informacja_dla_ pacjenta_SAPHO_ver1-1_final", "L1_4_Formularz Ankiety Uczestnika Badania_final", "L1_5_Formularz Swiadomej Zgody na Biobankowanie_final"); available materials are in Polish based on document titles/translations.

Inclusion criteria

  • {"criterion_text":"- Diagnosis of SAPHO syndrome according to modified Kahn criteria from 2003.\n- Age over 18.\n- Patient overall disease and pain assessment on VAS both ≥ 4 cm.\n- Expressing informed consent to participate in the study."}

Exclusion criteria

  • {"criterion_text":"- According to the Summary of Product Characteristics (SmPC) for Enbrel.\n- Pregnancy, breastfeeding, inability to use effective contraception during the examination.\n- Change in the dose of NSAIDs treatment in the last 4 weeks.\n- Dose modification of disease-modifying antirheumatic drugs (DMARDs) over the past 12 weeks.\n- Use of biological drugs / synthetic targeted drugs in the last 12 weeks.\n- Use of corticosteroids (orally or local injections) in the last 4 weeks.\n- Any medical condition that the investigator judges to contraindicate etanercept treatment."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Improvement in the scope of disease activity as assessed by the patient - a decrease in the overall disease activity as assessed by the patient on the VAS scale by min. 50% after 12 weeks and a decrease in pain assessed by the patient on the VAS scale by min. 50% after 12 weeks","definition_or_measurement_approach":"Patient-reported assessment using Visual Analogue Scale (VAS); a >=50% reduction in overall disease activity on VAS and >=50% reduction in pain on VAS at 12 weeks."}

Recruitment

Planned Sample Size
60
Recruitment Window Months
62
Consent Approach
Written informed consent is required from each participant ("Expressing informed consent to participate in the study"). All participants are adults (age over 18) so no parental consent or child assent is applicable. Subject information and consent documents are provided (document titles include ICF and information sheets such as "L1_1_ICF_ z_Informacja_dla_ pacjenta_SAPHO_ver1-1_final", pregnancy-specific information "L1_2_Informacja dla ciezarnej Uczestniczki_SAPHO_ver1-1_final"); documents are provided in Polish based on titles/translations.

Geography

Total Number Of Sites
3
Total Number Of Participants
60

Poland

Earliest CTIS Part Ii Submission Date
23-09-2024
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
574
Number Of Sites
3
Number Of Participants
60

Sites

Site Name
Pomeranian Medical University
Department Name
Klinika Chorób Wewnętrznych, Reumatologii, Diabetologii, Geriatrii i Immunologii
Contact Person Name
Hanna Przepiera-Będzak
Site Name
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
Department Name
Centrum Wsparcia Badań Klinicznych
Contact Person Name
Jakub Wroński
Contact Person Email
jakub.wronski@spartanska.pl
Site Name
University Of Warmia And Mazury
Department Name
Klinika Reumatologii
Contact Person Name
Magdalena Krajewska-Włodarczyk
Contact Person Email
magdalenakw@op.pl

Sponsor

Primary sponsor

Full Name
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Poland

Third parties

  • {"country":"Poland","full_name":"Jan Orłowski Orcon Pharma","duties_or_roles":"Codes: 1,10,11,3,5,6,7,8","organisation_type":"SME"}

Investigational products

Investigational Product Name
Enbrel (etanercept) - various authorised presentations (25 mg powder + solvent; 50 mg solution in pre-filled syringe)
Active Substance
Etanercept
Modality
Peptide/protein/enzyme
Routes Of Administration
Subcutaneous use
Route
Subcutaneous
Authorisation Status
Authorised (marketing authorisation in EU listed in product dictionary)
Maximum Dose
50 mg
Investigational Product Name
Water for Injections (placebo)
Active Substance
Water for Injections
Modality
Other
Routes Of Administration
Subcutaneous use
Route
Subcutaneous
Authorisation Status
Authorised (product record present as comparator/placebo)
Maximum Dose
2 ml

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