Summary
EudraCT Number:2021-005713-13
Sponsor's Protocol Code Number:21102
National Competent Authority:Spain - AEMPS
Clinical Trial Type:EEA CTA
Trial Status:Ongoing
Date on which this record was first entered in the EudraCT database:2022-04-19
Trial results
A. Protocol Information
A.1Member State ConcernedSpain - AEMPS
A.2EudraCT number2021-005713-13
A.3Full title of the trial
A Phase 2b Pivotal Study to Evaluate the Efficacy and Safety of Izokibep in Subjects with Moderate to Severe Hidradenitis Suppurativa
Estudio de fase IIb pivotal para evaluar la eficacia y la seguridad de izokibep en sujetos con hidradenitis supurativa de moderada a grave
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
A Study to Evaluate the Efficacy and Safety of Izokibep in Subjects with Moderate to Severe Hidradenitis Suppurativa
Estudio para evaluar la eficacia y la seguridad de izokibep en sujetos con hidradenitis supurativa de moderada a grave
A.4.1Sponsor's protocol code number21102
A.7Trial is part of a Paediatric Investigation Plan No
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorACELYRIN, Inc.
B.1.3.4CountryUnited States
B.3.1 and B.3.2Status of the sponsorCommercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing supportACELYRIN, Inc.
B.4.2CountryUnited States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationACELYRIN, Inc.
B.5.2Functional name of contact pointClinical Trial Information Desk
B.5.3 Address:
B.5.3.1Street Address23371 Mulholland Dr. PMB 417
B.5.3.2Town/ cityWoodland Hills
B.5.3.3Post codeCA 91364
B.5.3.4CountryUnited States
B.5.6E-mail[email protected]
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation No
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameIzokibep
D.3.2Product code ABY-035
D.3.4Pharmaceutical form Solution for injection
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPSubcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNIzokibep
D.3.9.1CAS number 2226130-02-3
D.3.9.2Current sponsor codeABY-035
D.3.9.3Other descriptive nameRecombinant protein comprising two IL-17A binding domains and an albumin binding domain
D.3.9.4EV Substance CodeSUB201240
D.3.10 Strength
D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number80
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin No
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product Yes
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
D.8 Placebo: 1
D.8.1Is a Placebo used in this Trial?Yes
D.8.3Pharmaceutical form of the placeboSolution for injection
D.8.4Route of administration of the placeboSubcutaneous use
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Hidradenitis Suppurativa
Hidradenitis Supurativa
E.1.1.1Medical condition in easily understood language
Hidradenitis Suppurativa
Hidradenitis Supurativa
E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.0
E.1.2Level LLT
E.1.2Classification code 10020041
E.1.2Term Hidradenitis suppurativa
E.1.2System Organ Class 100000004858
E.1.3Condition being studied is a rare disease Yes
E.2 Objective of the trial
E.2.1Main objective of the trial
Part A
- To explore the efficacy of izokibep as measured by HiSCR at Week 16
Part B
- To demonstrate that one or both treatment regimens of izokibep is efficacious compared to placebo, as measured by HiSCR at Week 16
Parte A
- Explorar la eficacia de izokibep medida mediante la HiSCR en la semana 16
Parte B
- Demostrar que uno o ambos regímenes de tratamiento con izokibep son eficaces en comparación con el placebo, medidos mediante HiSCR en la semana 16
E.2.2Secondary objectives of the trial
Part A
- To explore the safety and tolerability
- To explore the immunogenicity of izokibep as measured by the presence of ADAs
Part B
-To demonstrate that one or both regimens of izokibep is efficacious, as measured by:
• Percentage of subjects achieving at least 30% reduction from baseline in NRS30 in Patient Global Assessment of Skin Pain at its worst at Week 16 among participants with baseline NRS ≥3
• Percentage of subjects that experience ≥ 1 disease flare after 16 weeks of treatment
• Percentage of subjects with baseline Hurley Stage II who achieved AN count of 0, 1, or 2 at Week 16.
- To assess the safety and tolerability of izokibep as measured by the incidence of TEAEs, events of interest, SAEs, and clinically significant laboratory values and vital signs
- To assess the immunogenicity of izokibep as measured by the presence of ADAs
Parte A
- Evaluar la seguridad y la tolerabilidad
- Explorar la inmunogenicidad de izokibep medida por la presencia de AAF
Parte B
- Demostrar que uno o ambos regímenes de izokibep son eficaces, medidos por:
• El porcentaje de sujetos que logran una reducción de al menos el 30 % con respecto al inicio en EVN30 en la evaluación global del dolor cutáneo por parte del paciente en su peor momento en la semana 16 entre los participantes con una EVN inicial ≥3
• El porcentaje de sujetos que experimentan ≥1 exacerbación de la enfermedad después de 16 semanas de tratamiento
• El porcentaje de sujetos con estadio II de Hurley inicial que lograron un recuento de AN de 0, 1 o 2 en la semana 16.
- Evaluar la seguridad y la tolerabilidad de izokibep, medidas por la incidencia de AAST, acontecimientos de interés, AAG y valores analíticos y constantes vitales clínicamente significativos
- Evaluar la inmunogenicidad de izokibep medida por la presencia de AAF
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
- Subject (male and female) must be ≥ 18 and ≤ 75 years
- Diagnosis of HS for ≥ 1 year
- HS lesions present in ≥ 2 distinct anatomic areas, one of Hurley Stage II or Hurley Stage III
- A total AN count of ≥ 3 at screening
- Subject must have had an inadequate response to oral antibiotics (defined as ≥ 3-month treatment with an oral antibiotic for treatment of HS) OR exhibited recurrence after discontinuation to, OR demonstrated intolerance to, OR have a contraindication to oral antibiotics for treatment of their HS
- Subject must agree to use daily (throughout the duration of the study) one of the following over-the-counter topical antiseptics on their body areas affected with HS suppurativa lesions: chlorhexidine gluconate, triclosan, benzoyl peroxide, or diluted bleach in bathwater.
- Subject must be willing to complete a daily skin pain diary 7 consecutive days prior to Day 1
- No known history of active tuberculosis
- Subject has a negative tuberculosis test at screening
- Male and Female participants of childbearing potential must use effective methods of contraception

For a complete overview of the inclusion criteria refer to the protocol.
- El paciente (hombres y mujeres) debe tener ≥18 años y ≤75 años
- Diagnóstico de HS durante ≥1 año
- Lesiones de hidradenitis supurativa presentes en ≥2 zonas anatómicas distintas, una de las cuales está en estadio II de Hurley o estadio III de Hurley
- Un recuento de AN total ≥3 en la selección
- El paciente debe haber tenido una respuesta inadecuada a los antibióticos orales (lo que se define como tratamiento de ≥3 meses con un antibiótico oral para el tratamiento de la HS), O haber presentado recurrencia después de la interrupción del tratamiento, O haber mostrado intolerancia, O tener una contraindicación a los antibióticos orales para el tratamiento de la HS
- Debe aceptar usar todos los días (a lo largo del estudio) uno de los siguientes antisépticos tópicos de venta sin receta en las áreas corporales afectadas por lesiones de HS: gluconato de clorhexidina, triclosán, peróxido de benzoílo o lejía diluida en el agua de la bañera.
- El paciente debe estar dispuesto a cumplimentar un diario de dolor cutáneo durante 7 días consecutivos antes del día 1
- Sin antecedentes conocidos de tuberculosis activa
- El paciente presenta un resultado negativo en la prueba de tuberculosis en la selección
- Los participantes de sexo masculino y femenino en edad fértil deben utilizar métodos anticonceptivos eficaces

Para más información, consultar la lista completa en el protocolo de los criterios de inclusión
E.4Principal exclusion criteria
- Draining fistula count of > 20 at screening or Day 1 prior to enrollment/randomization
- Outpatient surgery ≤ 8 weeks prior or inpatient surgery ≤ 12 weeks prior to enrollment/randomization
- Other active skin disease or condition (eg, bacterial, fungal or viral infection) that could interfere with study assessments
- History of major autoimmune, chronic inflammatory, or connective tissue disease (eg, rheumatoid arthritis, psoriasis, psoriatic arthritis, axial spondyloarthritis, system lupus erythematosus, IBD) other than HS
- Chronic pain not associated with HS (eg, fibromyalgia).
- Uncontrolled, clinically significant system disease such as diabetes mellitus, cardiovascular disease including moderate to severe heart failure (New York Heart Association class III/IV), renal disease, liver disease or hypertension
- History of demyelinating disease (including myelitis) or neurological symptoms suggestive of demyelinating disease
- Malignancy within 5 years except treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, or in situ breast ductal carcinoma
- The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior or endorsing items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) assessed at screening. Subjects with major depressive disorder are permitted in the study if they are considered by the investigator to be stable and are taking no more than 1 medication. Subjects must have been on a stable dose within the 3 months prior to the first dose of study intervention
- History or evidence of any clinically significant disorder (including psychiatric), condition, or disease that, in the opinion of the Investigator, may pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
- Any active infection for which oral anti-infectives (antibiotics, antivirals, antifungals) were used ≤ 14 days prior to first dose of study intervention (except for the use of a stable dose allowable antibiotics [doxycycline or minocycline only] for HS)
- A serious infection requiring hospitalization or IV anti-infectives (antibiotics, antivirals, antifungals) ≤ 30 days prior to first dose of study intervention
- Recurrent or chronic infections or other active infections that in the opinion of the investigator might cause this study to be detrimental to the subject
- Candida infection requiring systemic treatment ≤ 3 months prior to first dose of study intervention
- Tuberculosis or fungal infection seen on available chest x-ray taken ≤ 3 months of screening or at screening
- Known history of human immunodeficiency virus (HIV)
- Previous exposure to izokibep or any other IL-17 receptor inhibitors (eg, secukinumab, ixekizumab, bimekizumab, brodalumab)
- Prior exposure to biologics that had a potential or known association with progressive multifocal leukoencephalopathy (ie, natalizumab [Tysabri ®], rituximab [Rituxan®], or efalizumab [Raptiva®])
- Exposure to TNF-α inhibitors, IL-1, IL-12, IL-23, or IL-12/23 receptor inhibitors within 5 half-lives prior to first dose of study intervention
- Exposure to the following ≤ 12 weeks prior to first dose of study intervention
• Other experimental or commercially available biologic or biosimilar therapies (within 12 weeks or 5 half-lives, whichever is longer)
• IV gamma-globulin or Prosorba column therapy
• Exposure to the following ≤ 4 weeks prior to first dose of study intervention
• JAK inhibitors (eg, tofacitinib, upadacitinib)
• Oral or injectable corticosteroids (including intralesional injections)
• Cyclosporine, azathioprine, tacrolimus
• Other systemic treatments for autoimmune/inflammatory conditions not listed above or below (eg, mycophenolate mofetil, retinoids, fumarates, apremilast, or phototherapy [eg, PUVA, UVA, UVB]), except for allowable stable dose antibiotics (doxycycline or minocycline)

For a complete overview of the exclusion criteria refer to the protocol.
- Recuento de fístulas drenantes >20 en la selección o el día 1 antes de la inscripción/aleatorización
- Cirugía ambulatoria ≤8 semanas antes o cirugía con hospitalización ≤12 semanas antes de la inscripción/aleatorización
- Otra enfermedad o afección cutánea activa (p. ej., infección bacteriana, fúngica o vírica) que pudiera interferir en las evaluaciones del estudio
- Antecedentes de enfermedad autoinmunitaria, inflamatoria crónica o del tejido conjuntivo importante (p. ej., artritis reumatoide, psoriasis, artritis psoriásica, espondiloartritis axial, lupus eritematoso sistémico, enfermedad inflamatoria intestinal) distinta de la HS
- Dolor crónico no asociado a la HS (p. ej., fibromialgia).
- Enfermedad sistémica clínicamente significativa no controlada, como diabetes mellitus, enfermedad cardiovascular, incluida la insuficiencia cardíaca moderada o grave (clase III/IV de la New York Heart Association), nefropatía, hepatopatía o hipertensión
- Antecedentes de enfermedad desmielinizante (incluida la mielitis) o síntomas neurológicos indicativos de enfermedad desmielinizante
- Neoplasia maligna en los últimos 5 años, excepto los casos tratados y que se consideren curados de carcinoma espinocelular o basocelular, carcinoma cervicouterino in situ o carcinoma ductal de mama in situ
- El paciente presenta riesgo de sufrir autolesiones o dañar a otras personas, evidenciado por una conducta suicida en el pasado o por la respuesta afirmativa a los ítems 4 o 5 de la Escala Columbia para evaluar el riesgo de suicidio (Columbia-Suicide Severity Rating Scale, C-SSRS) evaluada en la selección. Los pacientes con trastorno depresivo mayor podrán participar en el estudio si el investigador los considera estables y no están tomando más de 1 medicamento. Los pacientes deben haber recibido una dosis estable en los 3 meses anteriores a la primera dosis del tratamiento del estudio
- Antecedentes o indicios de cualquier trastorno (incluidos los psiquiátricos), afección o enfermedad clínicamente significativa que, en opinión del investigador, pueda suponer un riesgo para la seguridad del paciente o interferir en la evaluación, los procedimientos o la finalización del estudio
- Cualquier infección activa para la que se utilizasen fármacos antiinfecciosos orales (antibióticos, antivirales, antifúngicos) ≤14 días antes de la primera dosis del tratamiento del estudio (excepto el uso de una dosis estable de antibióticos permitidos [solo doxiciclina o minociclina] para la HS)
- Una infección grave que requiera hospitalización o fármacos antiinfecciosos i.v. (antibióticos, antivirales, antimicóticos) ≤30 días antes de la primera dosis del tratamiento del estudio
- Infecciones recurrentes o crónicas u otras infecciones activas que, en opinión del investigador, podrían hacer que este estudio fuera perjudicial para el paciente
- Infección por Candida que requiera tratamiento sistémico ≤3 meses antes de la primera dosis del tratamiento del estudio
- Tuberculosis o infección fúngica observada en la radiografía de tórax disponible, obtenida ≤3 meses antes de la selección o en la selección
- Antecedentes conocidos de virus de la inmunodeficiencia humana (VIH)
- Exposición previa a izokibep o a cualquier otro inhibidor del receptor de IL-17 (p. ej., secukinumab, ixekizumab, bimekizumab, brodalumab)
- Exposición previa a productos biológicos que tengan una asociación conocida o una posible asociación a la leucoencefalopatía multifocal progresiva (p. ej., natalizumab [Tysabri®], rituximab [Rituxan®] o efalizumab [Raptiva®])
- Exposición a inhibidores del TNF-α, inhibidores de los receptores de IL-1, IL-12, IL-23 o IL-12/23 en las 5 semividas previas a la primera dosis del tratamiento del estudio
- Exposición a los siguientes productos ≤12 semanas antes de la primera dosis del tratamiento del estudio:
• Otros tratamientos biológicos o biosimilares experimentales o comercializados (en el plazo de 12 semanas o 5 semividas, lo que sea más largo)
• Tratamiento con gammaglobulina i.v. o columna Prosorba
• Exposición a los siguientes productos ≤4 semanas antes de la primera dosis del tratamiento del estudio:
• Inhibidores de JAK (p. ej., tofacitinib, upadacitinib)
• Corticosteroides orales o inyectables (incluidas inyecciones intralesionales)
• Ciclosporina, azatioprina, tacrolimús
• Otros tratamientos sistémicos para enfermedades autoinmunitarias/inflamatorias no enumeradas anteriormente o a continuación (p. ej., micofenolato de mofetilo, retinoides, fumaratos, apremilast o fototerapia [p. ej., PUVA, UVA, UVB]), excepto antibióticos permitidos a dosis estables (doxiciclina o minociclina).

Para más información, consultar la lista completa en el protocolo de los criterios de exclusión
E.5 End points
E.5.1Primary end point(s)
Part A
HiSCR = hidradenitis suppurativa clinical response at week 16
Part b
HiSCR at week 16
Parte A
HiSCR en la semana 16
Parte B
HiSCR en la semana 16
E.5.1.1Timepoint(s) of evaluation of this end point
Part A
HiSCR - at Week 16
Part B
HiSCR - at Week 16
Parte A
HiSCR en la semana 16
Parte B
HiSCR en la semana 16
E.5.2Secondary end point(s)
Part A
- TEAEs and SAEs
- Laboratory values and vital signs at collected timepoints
- ADAs (= anti-drug antibodies)
Part B
- NRS30 in Patient Global Assessment of Skin Pain at its worst at Week 16
- HS flares through Week 16
- AN count of 0, 1, or 2 at Week 16
- TEAEs, events of interest, and SAEs
- Laboratory values and vital signs at collected timepoints
-ADAs
Parte A
- AAST y AAG
- Valores analíticos y constantes vitales en los puntos temporales de recogida
-AAF
Parte B
- EVN30 en la evaluación global del dolor cutáneo realizada por el paciente en su peor momento en la semana 16
- Exacerbaciones de la HS hasta la semana 16
- Un recuento de AN de 0, 1 o 2 en la semana 16
- AAST, acontecimientos de interés y AAG
- Valores analíticos y constantes vitales en los puntos temporales de recogida
- AAF
E.5.2.1Timepoint(s) of evaluation of this end point
Part A and Part B
- TEAEs and SAEs events of interest
- Laboratory values and vital signs at collected timepoints
- ADAs (= anti-drug antibodies)
From start of treatment to end of study.

- NRS30 in Patient Global Assessment of Skin Pain at its worst at Week 16
- HS flares through Week 16
- AN count of 0, 1, or 2 at Week 16
Parte A y Parte B
-AAST y AAG acontecimientos de interés
- Valores analíticos y constantes vitales en los puntos temporales de recogida
- AAF
Desde el inicio del tratamiento hasta el final del estudio.

- EVN30 en la evaluación global del dolor cutáneo realizada por el paciente en su peor momento en la semana 16
- Exacerbaciones de la HS hasta la semana 16
- Un recuento de AN de 0, 1 o 2 en la semana 16
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy No
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic Yes
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response Yes
E.6.10Pharmacogenetic No
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others Yes
E.6.13.1Other scope of the trial description
Immunogenecity
Inmunogenecidad
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) Yes
E.7.3Therapeutic confirmatory (Phase III) No
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open No
E.8.1.3Single blind No
E.8.1.4Double blind Yes
E.8.1.5Parallel group Yes
E.8.1.6Cross over No
E.8.1.7Other Yes
E.8.1.7.1Other trial design description
Parte A investigación exploratoria abierta de un solo grupo
Part A proof-of-concept, single-arm, open-label part
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo Yes
E.8.2.3Other No
E.8.2.4Number of treatment arms in the trial4
E.8.3 The trial involves single site in the Member State concerned No
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.4.1Number of sites anticipated in Member State concerned4
E.8.5The trial involves multiple Member States Yes
E.8.5.1Number of sites anticipated in the EEA25
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA Yes
E.8.6.2Trial being conducted completely outside of the EEA No
E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
Canada
Germany
Hungary
Poland
Spain
United States
E.8.7Trial has a data monitoring committee Yes
E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
LVLS
UVUP
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years1
E.8.9.1In the Member State concerned months2
E.8.9.1In the Member State concerned days0
E.8.9.2In all countries concerned by the trial years1
E.8.9.2In all countries concerned by the trial months2
E.8.9.2In all countries concerned by the trial days0
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.3Newborns (0-27 days) No
F.1.1.4Infants and toddlers (28 days-23 months) No
F.1.1.5Children (2-11years) No
F.1.1.6Adolescents (12-17 years) No
F.1.2Adults (18-64 years) Yes
F.1.2.1Number of subjects for this age range: 162
F.1.3Elderly (>=65 years) Yes
F.1.3.1Number of subjects for this age range: 18
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Yes
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Yes
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state20
F.4.2 For a multinational trial
F.4.2.1In the EEA 65
F.4.2.2In the whole clinical trial 180
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
There is no plan to continue access to study intervention after the end of study. The choice of further therapy for HS at the end of the clinical trial depends on the patient's individual needs and is left at the physician's discretion, based on available therapies approved for such use.
No está previsto continuar con el acceso a la intervención del estudio tras su finalización. La elección de una terapia adicional para la HS al final del ensayo clínico depende de las necesidades individuales del paciente y se deja a la discreción del médico, basándose en las terapias disponibles aprobadas para tal uso.
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2022-07-27
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2022-07-21
P. End of Trial
P.End of Trial StatusOngoing