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    Summary
    EudraCT Number:2012-003589-42
    Sponsor's Protocol Code Number:SP848-AKEx-1209
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-12-19
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-003589-42
    A.3Full title of the trial
    Observational (non-interventional), follow-up trial assessing long-term local tolerability and efficacy (recurrence rate) of resiquimod gel in patients treated for actinic keratosis.
    Beobachtende Folgestudie um die Langzeit-Verträglichkeit und Wirksamkeit (Häufigkeit des Wiederauftretens von AK-Läsionen) von Resiquimod Gel bei Patienten mit aktinischer Keratose, die zuvor mit Resiquimod Gel behandelt wurden, zu untersuchen.
    [Erweiterungsversuch zum klinischen Versuch SP848-AK-1101]
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Observational (non-interventional), follow-up trial assessing long-term local tolerability and efficacy (recurrence rate) of resiquimod gel in patients treated for actinic keratosis.
    Beobachtende Folgestudie ohne Behandlung, um die Langzeit-Verträglichkeit und Häufigkeit des Wiederauftretens von Sonnenschwielen bei Patienten, die zuvor mit Resiquimod Gel behandelt wurden, zu untersuchen.
    [Erweiterungsversuch zum klinischen Versuch SP848-AK-1101]
    A.4.1Sponsor's protocol code numberSP848-AKEx-1209
    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 SponsorSpirig Pharma AG
    B.1.3.4CountrySwitzerland
    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 supportSpirig Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSpirig Pharma AG
    B.5.2Functional name of contact pointInfo Contact
    B.5.3 Address:
    B.5.3.1Street AddressFroschackerstr. 6
    B.5.3.2Town/ cityEgerkingen
    B.5.3.3Post code4622
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41623878787
    B.5.6E-mailinfo@spirig.ch
    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 nameResiquimod Gel
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Actinic Keratosis
    Aktinische Keratose
    E.1.1.1Medical condition in easily understood language
    Solar Keratosis, Senile Kertosis
    Licht-Keratose, Solare Keratose, Sonnenschwielen
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10000614
    E.1.2Term Actinic keratosis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    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 extension trial is to determine the recurrence rate of AK-lesions in patients with complete clinical clearance at the end of the previous trial SP848-AK-1101 at 6 and 12 months of follow-up. The recurrence rate will be determined at the same treatment area where trial medications were administered in the previous trial (treated 25 cm2 area) and if possible per treatment group as assigned in trial SP848-AK-1101.
    Bestimmung der Häufigkeit eines Wiederauftretens der AK-Läsionen 6 und 12 Monate nach Ende des vorangegangenen Versuchs SP-848-AK-1101 bei Patienten mit vollständiger Heilung am Ende des Versuchs SP848-AK-1101. Die Häufigkeit des Wiederauftretens der Hautläsionen wird im selben Behandlungsfeld (25 cm2), in welchem das Resiquimod-Gel im Versuch SP848-AK-1101 aufgetragen wurde bestimmt und wenn möglich pro Behandlungsarm, in welchem die Patienten im Versuch SP848-AK-1101 eingeschlossen waren.
    E.2.2Secondary objectives of the trial
    For patients with complete clinical clearance:
    • Follow-up of unresolved adverse and serious adverse events occurred in the previous trial SP848-AK-1101 until resolution.
    • Follow-up of unresolved abnormal laboratory values occurred in the previous trial SP848-AK-1101 until resolution.
    • Newly occurred dermal adverse and serious adverse events on the previous treatment area.

    For Non-Responders:
    • Follow-up of AK-lesions (existing lesions, new lesions, changes)
    • Follow-up of non-resolved adverse and serious adverse events occurred in the previous trial SP848-AK-1101 until resolution.
    • Follow-up of unresolved abnormal laboratory values occurred in the previous trial SP848-AK-1101 until resolution.
    • Newly occurred dermal adverse and serious adverse events on the previous treatment area.
    Für Patienten mit vollständiger klinischer Heilung:
    • Nachverfolgung offener unerwünschter und schwerwiegender unerwünschter Ereignisse aus dem vorangegangenen Versuch SP848-AK-1101 bis Normalisierung.
    • Nachverfolgung offener abnormaler Laborwerte aus SP848-AK-1101 bis Normalisierung.
    • Neu aufgetretene unerwünschte und schwerwiegende unerwünschte Ereignisse im Behandlungsfeld aus SP848-AK-1101.

    Für Patienten, bei welchen die Versuchsbehandlung keine Wirkung gezeigt hatte und deshalb vorzeitig aus dem Versuch ausgeschieden waren:
    • Nachverfolgung vorhandener und neuer AK-Läsionen
    • Nachverfolgung offener unerwünschter und schwerwiegender unerwünschter Ereignissen SP848-AK-1101 bis Normalisierung.
    • Nachverfolgung offener abnormaler Laborwerte aus SP848-AK-1101 bis Normalisierung.
    • Neu aufgetretene unerwünschte und schwerwiegende unerwünschte Ereignisse im Behandlungsfeld aus SP848-AK-1101.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Signed informed consent.
    • Participation in the previous clinical trial SP848-AK-1101.
    • Patient with complete clinical clearance (i.e. no previously existing AK-lesion present) at the end of the trial SP848-AK-1101 or Non-Responder who withdrew from the trial prematurely.
    • Unterzeichnete Einverständniserklärung.
    • Teilnahme am vorausgegangenen Versuch SP848-AK-1101.
    • Patienten, die entweder eine vollständige Heilung am Ende des Versuchs erreicht hatten oder bei welchen die Versuchsbehandlung keine Wirkung gezeigt hatte und deshalb vorzeitig aus dem Versuch ausgeschieden waren.
    E.4Principal exclusion criteria
    • Evidence of unstable or uncontrolled clinically significant medical conditions as determined by the investigator (e.g., cardiovascular, immunological, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, infectious, gastrointestinal abnormalities or diseases).
    • Evidence of systemic cancer.
    • Dermatological disease or condition in the former treatment or surrounding area that might
    impair trial assessments (e.g., rosacea, atopic dermatitis, eczema) as assessed by the investigator.
    • Nachweis instabiler oder unkontrollierter, klinisch signifikanter Erkrankungen.
    • Nachweis eines systemischen Krebsleidens.
    • Dermatologische Erkrankung oder Zustand im Behandlungsbereich oder der Umgebung, die/der die Untersuchungen beeinflussen könnte (z.B.: Rosacea, atopische Dermatitis, Ekzem).
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy
    For patients with complete clinical clearance:
    • Number of patients with persistent complete clearance at 6 and 12 months follow-up. Recurrence rate is to be determined at the same treatment area where the investigational medicinal products were administered in the previous trial.
    Wirksamkeit
    • Anzahl der Patienten mit anhaltend vollständiger klinischer Heilung 6 und 12 Monate nach Ende des Versuchs SP848-AK-1101. Die Rate der Rezidiven wird im Behandlungsfeld des vorausgehenden Versuchs SP848-AK-1101 bestimmt.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 and 12 months after the end of trial SP848-AK-1101
    6 und 12 Monate nach Ende des Versuchs SP848-AK-1101
    E.5.2Secondary end point(s)
    Efficacy:

    For patients with complete clinical clearance:
    • Occurrence of new AK-lesions within the former treatment area.
    For Non-Responders:
    • Monitoring of AK-lesions on the former treatment area.

    Safety:

    For patients with complete clinical clearance and for Non-Responders:
    • Number of newly occurred dermal adverse and serious adverse events on the previous treatment area (local tolerability).
    Wirksamkeit

    Für Patienten mit vollständiger klinischer Heilung:
    • Auftreten neuer AK-Läsionen im Behandlungsfeld des Versuchs SP848-AK-1101.

    Für Patienten, bei welchen die Versuchsbehandlung keine Wirkung gezeigt hatte und deshalb vorzeitig aus dem Versuch ausgeschieden waren:
    • Beobachtung der AK-Läsionen im Behandlungsfeld des Versuchs SP848-AK-1101.

    Sicherheit

    Für Patienten mit vollständiger klinischer Heilung sowie für Patienten, bei welchen die Versuchsbehandlung keine Wirkung gezeigt hatte und deshalb vorzeitig aus dem Versuch ausgeschieden waren:
    • Anzahl neu aufgetretener dermaler unerwünschter Ereignisse und schwerwiegender unerwünschter Ereignisse im Behandlungsfeld des vorausgegangenen Versuchs SP848-AK-1101.
    E.5.2.1Timepoint(s) of evaluation of this end point
    ongoing
    fortlaufend
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    follow-up observational trial without treatment
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 No
    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
    Germany
    Switzerland
    E.8.7Trial has a data monitoring committee No
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 80
    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)
    In case of premature withdrawal or after study completion, patients will receive a standard treatment.
    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 Decision2013-01-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-09-04
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