Biopsy Based Study to Understand Mechanism of Action of Ianalumab in Salivary Glands and Explore Relationships With Clinical Assessments.

  • STATUS
    Recruiting
  • End date
    Feb 3, 2026
  • participants needed
    24
  • sponsor
    Novartis Pharmaceuticals
Updated on 4 October 2022

Summary

This study aims at elucidating the mechanism of action of ianalumab in salivary glands and explore relationships with clinical assessments

Description

This is an open-label, non-randomized, biopsy-based mechanistic study on pharmacokinetics, pharmacodynamics, safety and tolerability of ianalumab in patients with Sjögren's syndrome.

Details
Condition Sjogren Syndrome
Treatment ianalumab
Clinical Study IdentifierNCT05124925
SponsorNovartis Pharmaceuticals
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Confirmed primary Sjögren's syndrome according to the 2016 ACR/EULAR classification
criteria Seropositive for anti-Ro/SSA antibodies Screening ESSPRI score ≥ 5

Exclusion Criteria

Presence of another autoimmune rheumatic disease that is active and constitutes the primary
illness Prior use of ianalumab Prior use of any B cell depleting therapy (e.g., rituximab
or other anti-CD20 mAb, anti-CD22 mAb or anti-CD52 mAb) within 1 year prior to dosing B
cell count < 50 cells/μL at screening 6. Current use of prednisone >10 mg/day [or
equivalent other corticosteroid] or dose change within 2 weeks prior to dosing 7. Prior
treatment with any of the following within 6 months of baseline
CTLA4-Fc Ig (abatacept)
Anti-TNF-α mAb
Intravenous Ig
Plasmapheresis
i.v. or oral cyclophosphamide
i.v. or oral cyclosporine A
Patients taking either hydroxychloroquine more than 400 mg/day or methotrexate more
than 25 mg weekly or leflunomide at not stable dose within 3 months prior to dosing
Active viral, bacterial or other infections 9. History of major organ
hematopoietic stem cell or bone marrow transplant 10. History of hypersensitivity to
any of the study drugs or to drugs of similar chemical classes (e.g., mAb of IgG1
class) or to any of the constituents of the study drug (sucrose, L-Arginine
hydrochloride, L-histidine, polysorbate 80, hydrochloric acid) 11. Required regular
use of medications known to cause dry mouth/eyes as a regular and major side effect
Receipt of live/attenuated vaccine within a 2 month period before baseline 13
History of primary or secondary immunodeficiency, or a positive HIV (ELISA and Western
blot) test result 14. History of malignancy of any organ system (other than localized
basal cell carcinoma of the skin, in situ cervical cancer), treated or untreated
within the past 5 years, regardless of whether there is evidence of local recurrence
or metastases
History of head and neck radiation therapy or of having received radioactive
iodine 16. Any one of the following screening values of CBC laboratory values
Hemoglobin levels below 8.0 g/dL
Total leukocyte count less than 2,000/μL
Platelets <50 x 109/L (if between 50 and 80, the PI should check that it is
linked to Sjögren's syndrome and not to any other disease)
Absolute neutrophil count (ANC) <1.0 x 109/L (one re-test is allowed during the
screening period) 17. Positive serology for hepatitis B surface antigen (HBsAg)
Positive serology for hepatitis B core antibody (HBcAb), except if all 3 following
criteria are met
HBV quantitative PCR for viral DNA is negative (i.e., <10 IU)
prophylactic treatment (with tenofovir or entecavir) initiated latest on day 1
and continued until 12 months after last treatment
hepatitis B monitoring is implemented: HBsAg (and HBV DNA) tested every 4 weeks
and at least every 12 weeks after end of treatment for the entire duration of the
follow-up. Antiviral prophylaxis must be implemented while on study and up to 12
months after end of study treatment
Positive hepatitis C test result. Participants with a positive HCV antibody
test should have HCV RNA levels measured. Participants with positive (detectable)
HCV RNA should be excluded
Evidence of active tuberculosis (TB) infection (after anti-TB treatment
patients with history of or latent TB may become eligible according to national
guidelines) 20. Pregnant or nursing (lactating) women, where pregnancy is defined
as the state of a female after conception and until the termination of gestation
confirmed by a positive hCG laboratory test 21. Women of child-bearing potential
(WOCBP), defined as all women physiologically capable of becoming pregnant
unless they are using highly effective methods of contraception during dosing and
for 6 months after stopping of investigational medication. Highly effective
contraception methods include
Total abstinence (when this is in line with the preferred and usual lifestyle of
the patient). Periodic abstinence (e.g., calendar, ovulation, symptothermal
post-ovulation methods) and withdrawal are not acceptable methods of
contraception
Female sterilization (have had surgical bilateral oophorectomy with or without
hysterectomy) total hysterectomy or tubal ligation at least six weeks before
taking investigational drug. In case of oophorectomy alone, only when the
reproductive status of the woman has been confirmed by follow up hormone level
assessment
Male sterilization (at least 6 months prior to screening and confirmed as
successful). For female patients in the study, the vasectomized male partner
should be the sole partner for that patient
Use of oral, (estrogen and progesterone), injected or implanted hormonal methods
of contraception or placement of an intrauterine device (IUD) or intrauterine
system (IUS) or other forms of hormonal contraception that have comparable
efficacy (failure rate <1%), for example hormone vaginal ring or transdermal
hormone contraception. In case of use of oral contraception women should have
been stable on the same pill for a minimum of 3 months before taking
investigational drug
Women are considered post-menopausal and not of child bearing potential if they have
had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile
(e.g., age appropriate, history of vasomotor symptoms) or have had surgical bilateral
oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at
least six weeks ago. In the case of oophorectomy alone, only when the reproductive
status of the woman has been confirmed by follow up hormone level assessment is she
considered not of child bearing potential
If local regulations deviate from the contraception methods listed above to prevent
pregnancy, local regulations apply and will be described in the informed consent form
(ICF)
Known contraindication to SonoVue (sulphur hexafluoride microbubbles) ultrasound
contrast agent 23. Participants not registered in the social security system 24
Participants within the exclusion period of a preceding study 25. Any surgical
medical (e.g. uncontrolled hypertension, heart failure or diabetes) psychiatric or
additional physical condition that the investigator feels may jeopardize the patient
in case of participation in this study 26. People deprived of their liberty by a
judicial or administrative decision (Article L1121-6 of the French Public Health Code)
Screening Labial minor salivary gland (LMSG) biopsy lymphocyte focus score < 0.5 or
B/B+T ratio in the gland < 0.2
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