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    The EU Clinical Trials Register currently displays   42316   clinical trials with a EudraCT protocol, of which   6969   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


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    Summary
    EudraCT Number:2020-004108-33
    Sponsor's Protocol Code Number:M20-262
    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:2021-12-15
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2020-004108-33
    A.3Full title of the trial
    A Phase 2 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lutikizumab (ABT-981) in Adult Subjects with Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy
    Estudio de fase 2 multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar la seguridad y la eficacia de lutikizumab (ABT-981) en sujetos adultos con hidradenitis supurativa moderada o grave que no han respondido al tratamiento anti-TNF
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Evaluating the Safety and Efficacy of Lutikizumab (ABT-981) Versus Placebo in Adult Participants with Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy
    Estudio que evalúa la seguridad y eficacia de lucikizumab (ABT-981) frente a placebo en sujetos adultos con hidradenitis supurativa de moderada a grave que que no han respondido al tratamiento anti-TNF
    A.4.1Sponsor's protocol code numberM20-262
    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 SponsorAbbVie Deutschland GmbH & Co. KG
    B.1.3.4CountryGermany
    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 supportAbbVie Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628561090
    B.5.5Fax number+441628461153
    B.5.6E-mailabbvie_reec@abbvie.com
    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 nameLutikizumab
    D.3.2Product code ABT-981
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNLUTIKIZUMAB
    D.3.9.1CAS number 1791411-57-8
    D.3.9.2Current sponsor codeABT-981
    D.3.9.3Other descriptive nameA-1234138
    D.3.9.4EV Substance CodeSUB187253
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 in pre-filled syringe
    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 is a chronic skin disease that creates red, swollen, painful bumps which can break open to combine and form tunnels in the skin and scars.
    La hidradenitis supurativa es una enfermedad crónica de la piel que crea protuberancias rojas, hinchadas y dolorosas que pueden abrirse para combinarse y formar túneles en la piel y cicatrices.
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to assess the safety and efficacy of two different doses of lutikizumab, a high dose administered every week (EW) or every other week (EOW), and a low dose administered EOW, versus placebo for the treatment of signs and symptoms of moderate to severe HS in adult subjects who have failed anti-TNF therapy.
    El objetivo principal de este estudio es evaluar la seguridad y la eficacia de dos dosis diferentes de lutikizumab, una dosis alta administrada cada semana (EW) o cada dos semanas (EOW), y una dosis baja administrada EOW en comparación con un placebo para el tratamiento de los signos y síntomas de la HS moderada o grave en adultos que no han respondido al tratamiento anti-TNF
    E.2.2Secondary objectives of the trial
    The secondary endpoint is the achievement of at least a 30% reduction and at least 1-unit reduction from Baseline in worst skin pain (maximal daily pain) at Week 16, as assessed by the Patient's Global Assessment (PGA) of Skin Pain (Numeric Rating Scale [NRS] 30) among subjects with baseline NRS ≥ 3.
    El criterio de valoración secundario es la consecución de una reducción de al menos el 30 % y una reducción de al menos una unidad del peor dolor cutáneo (dolor diario máximo) entre el momento basal y la semana 16, según la evaluación global del paciente (PGA) del dolor cutáneo (escala de valoración numérica [EVN] 30) en los sujetos con una EVN basal ≥3.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subjects must be ≥ 18 years of age at Screening with a clinical diagnosis of hidradenitis suppurativa (HS) for at least 1 year prior to Baseline as determined by the investigator.
    - A total abscess and inflammatory nodule (AN) count of >= 5 at Baseline
    - HS lesions must be present in at least 2 distinct anatomic areas.
    - Must have failed anti-TNF treatment for HS.
    • Los sujetos deberán tener una edad ≥ 18 años en el periodo de selección, un diagnóstico clínico de HS desde al menos un año antes del momento basal según lo determinado por el investigador.
    • Un recuento total de abscesos y nódulos inflamatorios (AN) ≥5 en el momento basal
    • presencia de lesiones de HS en dos regiones anatómicas distintas como mínimo.
    • Los sujetos no habrán respondido al tratamiento anti-TNF para la HS.
    E.4Principal exclusion criteria
    History of active skin disease other than HS that could interfere with the assessment of HS, including skin infections (e.g., bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline visit.
    Antecedentes de enfermedades cutáneas activas distintas de la HS que puedan interferir con la evaluación de la HS, incluidas las infecciones cutáneas (por ejemplo, bacterianas, fúngicas o virales) que requieran tratamiento sistémico en las 4 semanas siguientes a la visita inicial.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the achievement of HiSCR at Week 16. HiSCR is defined as at least a 50% reduction from Baseline in the total AN count, with no increase in abscess count and no increase in draining fistula-count relative to Baseline.
    El criterio de valoración principal es la consecución de una RCHS en la semana 16. La RCHS se define como una reducción de al menos el 50 % en el total de AN sin un aumento del número de abscesos ni del número de fístulas supurantes con respecto al momento basal.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    Semana 16
    E.5.2Secondary end point(s)
    The secondary endpoint is the achievement of at least a 30% reduction and at least 1-unit reduction from Baseline in worst skin pain (maximal daily pain) at Week 16, as assessed by the Patient's Global Assessment (PGA) of Skin Pain (Numeric Rating Scale [NRS] 30) among subjects with baseline NRS ≥ 3.
    El criterio de valoración secundario es la consecución de una reducción de al menos el 30 % y una reducción de al menos una unidad del peor dolor cutáneo (dolor diario máximo) entre el momento basal y la semana 16, según la evaluación global del paciente (PGA) del dolor cutáneo (escala de valoración numérica [EVN] 30) en los sujetos con una EVN basal ≥3
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 16
    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 Yes
    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 No
    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 No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Australia
    Canada
    Germany
    Greece
    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
    The end-of-study is defined as the date of end of study participation by the last subject in the study (i.e., the date of the last subject's last visit or date of last follow-up contact, whichever is later.)
    El final del estudio se define como la fecha de finalización de la participación en el estudio por parte del último paciente del mismo (es decir, la fecha de la última visita del último paciente o la fecha del último contacto de seguimiento, lo que sea posterior).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 60
    F.4.2.2In the whole clinical trial 160
    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)
    Subjects will continue on study treatment throughout the study for a period of up to 16 weeks or until premature discontinuation of study drug.
    AbbVie will not provide Lutikizumab or any other therapy once the subject's participation is conclued.
    Los pacientes continuarán con el tratamiento del estudio durante un período de hasta 16 semanas o hasta la interrupción prematura del fármaco del estudio.

    AbbVie no proporcionará lutikizumab ni ninguna otra terapia una vez concluida la participación del paciente.
    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 Decision2022-03-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-14
    P. End of Trial
    P.End of Trial StatusOngoing
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