Basta 2

• Register: EUCTR
• Last refreshed on: 30 January 2023
• Main ID: EUCTR2022-001484-27-NL
• Date of registration: 29/10/2022
• Prospective Registration: Yes
• Primary sponsor: radboudumc
• Public title: Basta 2
• Scientific title: B cell Activation in Sjögren's Syndrome, Cutaneous Lupus Erythematodus and Systemic Sclerosis Tissues Analysis 2 - Basta 2
• Date of first enrolment: 24/01/2023
• Target sample size: 30
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2022-001484-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Netherlands

Contacts

• Name: department of rheumatology
• Affiliation: Radboudumc

• Name: department of rheumatology
• Affiliation: Radboudumc

Key inclusion & exclusion criteria

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

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.




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Systemic Sclerosis Sjögren's Syndrome Cutaneous Lupus Erythematodus

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

Product Name: [89Zr]Zr-Df-crefmirlimab berdoxam
Product Code: IND 127861
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: [89Zr]Zr-Df-crefmirlimab berdoxam
Other descriptive name: Minibody against CD8 conjugated to desferrioxamine labeled with zirconium Zr 89
Concentration unit: MBq/ml megabecquerel(s)/millilitre
Concentration type: equal
Concentration number: 4.625-

Primary Outcome(s)

Primary 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

Secondary Objective: Not applicable

Main Objective: 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.

Timepoint(s) of evaluation of this end point: LVLS

Secondary Outcome(s)

Secondary end point(s): Not applicable

Timepoint(s) of evaluation of this end point: LVLS

Secondary ID(s)

NL67672.091.18

107802

Source(s) of Monetary Support

Radboudumc

ReumaNederland

GSK

Health Holland Match PPS

Galapagos

Ethics review

Status: Approved
Approval date: 16/05/2019
Contact: