Página Nct de ensaios clínicos

Summary
EudraCT Number:2022-001484-27
Sponsor's Protocol Code Number:NL67672.091.18
National Competent Authority:Netherlands - Competent Authority
Clinical Trial Type:EEA CTA
Trial Status:Ongoing
Date on which this record was first entered in the EudraCT database:2022-10-29
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
A. Protocol Information
A.1Member State ConcernedNetherlands - Competent Authority
A.2EudraCT number2022-001484-27
A.3Full title of the trial
B cell Activation in Sjögren's Syndrome, Cutaneous Lupus Erythematodus and Systemic Sclerosis Tissues
Analysis 2
B cel activatie in Syndroom van Sjögren, Cutane Lupus Erythematodus en Systemische Sclerose Weefsel
Analyse 2
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
Basta 2
Basta 2
A.3.2Name or abbreviated title of the trial where available
Basta 2
Basta 2
A.4.1Sponsor's protocol code numberNL67672.091.18
A.5.4Other Identifiers
Name:PaNaMaNumber: 107802
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 Sponsorradboudumc
B.1.3.4CountryNetherlands
B.3.1 and B.3.2Status of the sponsorNon-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing supportRadboudumc
B.4.2CountryNetherlands
B.4.1Name of organisation providing supportHealth Holland Match PPS
B.4.2CountryNetherlands
B.4.1Name of organisation providing supportReumaNederland
B.4.2CountryNetherlands
B.4.1Name of organisation providing supportGSK
B.4.2CountryNetherlands
B.4.1Name of organisation providing supportGalapagos
B.4.2CountryBelgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationRadboudumc
B.5.2Functional name of contact pointdepartment of rheumatology
B.5.3 Address:
B.5.3.1Street AddressG. Grooteplein Z-10
B.5.3.2Town/ cityNijmegen
B.5.3.3Post code6525 GA
B.5.3.4CountryNetherlands
B.5.4Telephone number0031(0)243614580
B.5.6E-mailrogier.thurlings@radboudumc.nl
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 name[89Zr]Zr-Df-crefmirlimab berdoxam
D.3.2Product code IND 127861
D.3.4Pharmaceutical form Solution for infusion
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPIntravenous use
Solution for infusion (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INN[89Zr]Zr-Df-crefmirlimab berdoxam
D.3.9.3Other descriptive nameMinibody against CD8 conjugated to desferrioxamine labeled with zirconium Zr 89
D.3.9.4EV Substance CodeSUB218013
D.3.10 Strength
D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number4.625
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 Yes
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
Systemic Sclerosis
Sjögren's Syndrome
Cutaneous Lupus Erythematodus
Systemische Sclerose
Syndroom van Sjögren
Cutane Lupus Erythematodus
E.1.1.1Medical condition in easily understood language
Scleroderma
Sjögren's Syndrome
CLE
Sclerodermie
Syndroom van Sjögren
CLE
E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
MedDRA Classification
E.1.3Condition being studied is a rare disease Yes
E.2 Objective of the trial
E.2.1Main objective of the trial
Objective: Investigate patients with CLE, SSj and SSc to:
1.Comparatively analyze the B and T cell repertoire in locoregional lymph node versus blood and involved skin (CLE, SSc) and salivary gland (SSj) for shared clonal expansions, somatic hypermutation, preferential gene usage and ontogenetic relations.
2.analyze lineage commitment and expression of activation and regulatory factors of activated and expanded T cell clones in the locoregional lymph node.
3.Analyze the subset origin of expanded B cell clones by comparative analysis of FACS sorted B cells from peripheral blood.
4.Compare [18F]FLT and [89Zr] Df-IAB22M2C anti-CD8 PET imaging as a tool to select involved lymph nodes for biopsy.
E.2.2Secondary objectives of the trial
Not applicable
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
General inclusion criteria are age > 50 years for patients undergoing a [89Zr] anti-CD8 PET scan because of the necessary radioactive dose for this scan.

Inclusion criteria for SSj patients are: diagnosis of primary SSj according to the European American consensus group criteria (15) and presence of anti-nuclear (ANA), anti-SSA and/or anti-SSB antibodies.

Inclusion criteria for CLE patients are: diagnosis of subacute cutaneous lupus erythematosus (SCLE) or SLE with cutaneous lupus according to the Düsseldorf classification criteria (22). Presence of anti-nuclear (ANA), anti-SSA and/or anti-SSB antibodies. Active skin disease as assessed by the treating physician.

Inclusion criteria for the SSc patients are: diagnosis of early diffuse cutaneous SSc, according to the VEDOSS criteria defined as having a diffuse skin involvement, presence of anti-nuclear antibodies (ANA), a disease duration (from first non-Raynaud symptom) of < 3 years and progressive disease as defined by an increase in mean Rodnan skin score (mRSS) > 10 points or > 25% in the past year. Patients will be selected with skin involvement of the legs, which allows the analysis of an inguinal lymph node as locoregional lymph node.
E.4Principal exclusion criteria
Exclusion criteria for SSj, CLE and SSc patients are presence of active concurrent inflammatory or infectious condition, current or previous use of biologic treatment, previous other systemic autoimmune disease diagnosis or positive serology for hepatitis C or Human Immunodeficiëncy Virus.

SSj, CLE and SSc patients will be asked for separate consent for collection of a lymph node tissue biopsy. Analysis of lymph node biopsies in patients with allow the direct comparison of autoreactive B and T cell expansions, controlling for tissue specific regulatory mechanisms.

E.5 End points
E.5.1Primary end point(s)
The difference between CLE, SSj and SSc in differentiation, activation and regulation of expanded B and T cell clones, shared between locoregional lymph node versus involved skin and salivary gland
E.5.1.1Timepoint(s) of evaluation of this end point
LVLS
E.5.2Secondary end point(s)
Not applicable
E.5.2.1Timepoint(s) of evaluation of this end point
LVLS
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 No
E.6.5Efficacy No
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 Yes
E.6.13.1Other scope of the trial description
An exploratory analysis in three transversal patient cohorts involving two study visits for clinical assessment, blood withdrawal, [18F]FLT and [89Zr] anti-CD8 PET imaging (1:1) and 1) for SSj patients a salivary gland biopsy and optionally a lymph node biopsy, 2) for SSc and CLE patients a skin biopsy of involved an of uninvolved skin and optionally a lymph node biopsy.
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 Yes
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 No
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 Yes
E.8.4 The trial involves multiple sites in the Member State concerned No
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 No
E.8.6.2Trial being conducted completely outside of the EEA No
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 years2
E.8.9.1In the Member State concerned months
E.8.9.1In the Member State concerned days
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: 15
F.1.3Elderly (>=65 years) Yes
F.1.3.1Number of subjects for this age range: 15
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 No
F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
F.3.3.3Pregnant women Information not present in EudraCT
F.3.3.4Nursing women Information not present in EudraCT
F.3.3.5Emergency situation Information not present in EudraCT
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 state30
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)
Best standard of care
Beste standaard behandeling
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 Decision2023-01-24
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2019-05-16
P. End of Trial
P.End of Trial StatusOngoing

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