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    Summary
    EudraCT Number:2011-003943-23
    Sponsor's Protocol Code Number:SP848-AK-1101
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-11-24
    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 number2011-003943-23
    A.3Full title of the trial
    Prospective, randomized, partly blinded, in part placebo-controlled, multicenter, dose-finding trial exploring safety, tolerability and efficacy of a topical resiquimod gel in patients with multiple actinic keratosis lesions
    Prospektive, randomisierte, teilweise verblindete, teils plazebokontrollierte multizentrische klinische Prüfung zur Untersuchung der geeigneten Dosierung, der Sicherheit, Verträglichkeit und Wirksamkeit eines äusserlich anwendbaren Resiquimod-Gels bei Patienten mit multiplen Läsionen einer aktinischen Keratose
    A.4.1Sponsor's protocol code numberSP848-AK-1101
    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 point
    B.5.3 Address:
    B.5.3.1Street AddressFroschackerstrasse 6
    B.5.3.2Town/ cityEgerkingen
    B.5.3.3Post code4622
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41623878787
    B.5.5Fax number+41623878799
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNResiquimod
    D.3.9.1CAS number 144875-48-9
    D.3.9.2Current sponsor code R-848
    D.3.9.3Other descriptive nameS-28463, VML600
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.01%
    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.IMP: 2
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNResiquimod
    D.3.9.1CAS number 144875-48-9
    D.3.9.2Current sponsor codeR-848
    D.3.9.3Other descriptive nameS-28463, VML600
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.03%
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboGel
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    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 Keratosis
    Licht-Keratose, Solare Keratose
    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 16.1
    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 is to define the concentration and dosage schedule of resiquimod gel at which complete clearance (no AK-lesion according to clinical inspection in a treated 25 cm2 area) occurs (Treatment Arms 1, 2, 3), or at which a biological endpoint (clinical manifestation of skin erosion, that is the skin appears reddened, erosive and weeping) is achieved with subsequent complete clearance (Treatment Arms 4 and 5).
    E.2.2Secondary objectives of the trial
    Secondary objectives relate to the efficacy, local tolerability and the safety of the various concentrations and dosage schedules of resiquimod gel in terms of
    • complete clinical clearance in the treated 25 cm2 field at starting point of second treatment cycle
    • partial clearance (disappearance of ≥75% of AK-lesions in the treated 25 cm2 area) at the end of trial
    • complete clearance of the entire treatment field (=25 cm2 area), verified by confocal microscopy at the end of trial (optional, at specific centers)
    • histological proof of clearance of an indicator lesion at the end of trial
    • global judgment of efficacy and tolerability by the investigator and the patient based on point scores at the starting point of the second treatment cycle (Treatment Arms 1, 2, 3) and at the end of the trial (all Treatment Arms)
    • number of patients withdrawn from trial
    • quality of life (QoL) assessment
    • number of adverse and serious adverse events
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Signed informed consent
    • Male or nonpregnant, nonlactating female, ≥18 years. For women of childbearing potential the use of highly effective methods of birth control (precautions to prevent pregnancy) is mandatory. Highly effective methods of birth control are defined as those, alone or in combination, which result in a low failure rate (i.e. less than 1 % per year) when used consistently and correctly - such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. In this trial women of childbearing potential are instructed to use oral contraceptives or IUDs in combination with a barrier device (e.g. condom).
    • A minimum of 2 clinically diagnosed AK-lesions within a 25 cm2 contiguous treatment area (balding scalp, forehead, face). One AK-lesion must have a diameter of at least 6 mm (indicator lesion).The patient may have been treated in the past for AK-lesions. But for the existing AK-lesions the restrictions for treatments before the start of the trial must be observed (see below exclusion criteria).
    • Free of other significant findings in the treatment field that could impair examination of the treatment or surrounding area (defined as the area within a 5 cm margin of the treatment area
    in all directions).
    • Willing and able to participate in the trial as an outpatient and comply with all trial requirements.
    E.4Principal exclusion criteria
    • Evidence of unstable or uncontrolled clinically significant medical conditions as determined by the investigator (e.g., cardiovascular, immunosuppressive, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, gastrointestinal abnormalities or diseases).
    • Evidence of an active infection.
    • Evidence of immunosuppression or systemic cancer.
    • Known autoimmune disorder (especially psoriasis), impaired immune system (e.g. HIV), known thyroid abnormalities, known depression.
    • Dermatological disease or condition in the treatment or surrounding area that might be exacerbated by treatment with resiquimod gel or may impair trial assessments (e.g., rosacea, atopic dermatitis, eczema) as assessed by the investigator.
    • Current alcohol abuse or chemical dependency as assessed by the investigator.
    • Participation in another clinical trial within one month of trial entry.
    • Known allergy or hypersensitivity to any of the trial gel ingredients.
    • Pretreatments for the existing AK-lesions are restricted before the start of the trial, in the sense that different periods of grace must be observed:
    • Local/topical treatments in the treatment area
    • Dermabrasion, chemical peeling, laser treatment, cryotherapy or surgery within 6 weeks of trial entry
    • Imiquimod, diclofenac, 5-Fluorouracil (5-FU), topical corticosteroids, topical retinoids, treatment of the head with ultraviolet B (UVB) or photodynamic treatment (PDT) within 6
    weeks of trial entry
    • Systemic treatments
    • High-dose vitamin A (>15’000 units per day) within 2 weeks of trial entry
    • Interferon/ interferon-inducers, immunosuppressors, immunomodulatory medicinal products, systemic (>10 mg/day) or high-dosed inhaled (>1600 μg/day) corticosteroids within 4 weeks of trial entry
    • Chemotherapy or systemic retinoids within 6 months of trial entry.
    E.5 End points
    E.5.1Primary end point(s)
    • Number of patients with complete clinical clearance (no AK-lesion according to clinical inspection in the treated 25 cm2 area) at the end of trial.
    • Number of patients with complete clinical clearance after reaching a biological endpoint (manifestation of skin erosion, i.e., reddened, erosive and weeping skin) plus 8 weeks follow-up (in Treatment Arms 4 and 5).
    E.5.1.1Timepoint(s) of evaluation of this end point
    • At the end of trial.
    • After reaching a biological endpoint (manifestation of skin erosion, i.e., reddened, erosive and weeping skin) plus 8 weeks follow-up (in Treatment Arms 4 and 5).
    E.5.2Secondary end point(s)
    Efficacy
    • Number of patients with complete clinical clearance (clinical inspection) in the treated 25 cm2 area at starting point of the second treatment cycle (Treatment Arms 1-3).
    • Number of patients with partial clearance (disappearance of ≥75%) of AK-lesions (clinical inspection) in the treated 25 cm2 area at the end of trial.
    • Number of patients with clearance of the entire treatment field, verified by confocal microscopy (optional, at specific centers) at the end of trial.
    • Number of patients with histological proof of clearance of the indicator lesion at the end of trial.
    • Global judgment of efficacy by investigator and patient by means of point scores at the starting point of the second treatment cycle (Treatment Arms 1, 2, 3) and at the end of trial (all Treatment Arms).
    • QoL assessments (by means of Skindex-29) at Day 1 (Visit 2), after the first treatment period (Visit 3) in the Treatment Arms 1, 2 and 3, or after reaching the biological endpoint (skin erosion) in the Treatment Arms 4 and 5, and at the end of the trial (all Treatment Arms)
    Safety
    • Evaluation of adverse events (AEs) and serious adverse events (SAEs).
    • Evaluation of local and systemic tolerability.
    • Global judgment of tolerability by investigator and patient by means of point scores at the starting point of the second treatment cycle (Treatment Arms 1,2,3) and the end of trial (all Treatment Arms).
    • Number of patients withdrawn from the trial (discontentment with efficacy, poor tolerability, safety reasons, withdrawal of informed consent)
    • Evaluation of patient compliance based on trial medication records.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Start of second treatment cycle (Arms 1-3):
    - No. of patients (pts) with complete clinical clearance in treated area
    - Global judgment of efficacy and tolerability by investigator and pts
    • End of trial:
    - No. of pts with partial clearance (disappearance of ≥75%) of AK-lesions in treated area
    - No. of pts with clearance of entire treatment field, verified by confocal microscopy (optional)
    - No. of pts with histological proof of clearance of indicator lesion
    - Global judgment of efficacy and tolerability by investigator and pts
    QoL assessments
    • Visit 2 (all Arms) Visit 3 (Arms 1-3) or after reaching biological endpoint (Arms 4, 5):
    - QoL assessments
    • Ongoing:
    - Evaluation of AEs and SAEs, local and systemic tolerability and pts compliance
    - No. of pts withdrawn
    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 No
    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 No
    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
    partly blinded, partly placebo-controlled
    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 trial5
    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 concerned12
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA0
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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.1.3Elderly (>=65 years) Yes
    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 state104
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 104
    F.4.2.2In the whole clinical trial 208
    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 Decision2012-03-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-11-25
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