A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS)

• Register: EUCTR
• Last refreshed on: 3 December 2024
• Main ID: EUCTR2021-000665-32-NL
• Date of registration: 21/10/2021
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International NV
• Public title: A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS)
• Scientific title: Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS)
• Date of first enrolment: 16/02/2022
• Target sample size: 150
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-000665-32
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

France, Germany, Italy, Japan, Netherlands, Poland, Portugal, Spain, Taiwan, United States

Contacts

• Name: Clinical Registry Group
• Affiliation: Janssen-Cilag International NV

• Name: Clinical Registry Group
• Affiliation: Janssen-Cilag International NV

Key inclusion & exclusion criteria

Inclusion criteria:
- Meets classification criteria for primary sjogren's syndrome (pSS) by the 2016 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) at the time of screening, (results either
obtained during screening or documented in the participant's medical
history are acceptable to fulfill these criteria for Schirmer's
test, unstimulated salivary flow test, ocular staining score, or labial
salivary gland biopsy), and was diagnosed with pSS no less than 26 weeks prior to screening
- At screening is seropositive for antibodies to pSS-associated antigen A Ro/sjogren's syndrome-related antigen [SSA])
- Total Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (clinESSDAI) score greater than or equal to (>=) 6
- At least one abnormal laboratory marker of pSS-related inflammatory disease activity, and at least low activity in one or more specified European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ESSDAI) domains
- It is recommended to be up to date on all age-appropriate vaccinations prior to screening as per routine local medical guidelines. It is strongly recommended that participants will have completed a locally-approved (or emergency use-authorized) coronavirus disease 2019 (COVID-19) vaccination regime at least 2 weeks prior to study related visits or procedures. Study participants should follow applicable local vaccine labelling, guidelines, and standards-of-care for patientss receiving immune-targeted therapy will be followed when determining an appropriate interval between vaccination and study enrollment.
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 135
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion criteria:
-Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her pSS or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
- Comorbidities (for example, asthma, chronic obstructive pulmonary disease) which have required 3 or more courses of systemic glucocorticoids within the previous 12 months
- Has any unstable or progressive manifestation of pSS that is likely to
warrant escalation in therapy beyond permitted background medications
and/or has severely active pSS
- Has received oral cyclophosphamide within 3 months or intravenous (IV) cyclophosphamide within 6 months prior to first administration of study intervention
- Has sjogren's syndrome overlap syndromes where another confirmed autoimmune rheumatic or systemic inflammatory condition (that is, rheumatoid arthritis [RA], systemic lupus erythematosus [SLE], scleroderma, inflammatory bowel disease [IBD]) is the primary diagnosis or has clinical manifestations that, in the opinion of the investigator, or the sponsor or sponsor's representative are likely to interfere with the investigator's ability to assess pSS manifestations


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

Health Condition(s) or Problem(s) studied

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

Primary Sjogren's Syndrome
MedDRA version: 21.0 Level: LLT Classification code 10040766 Term: Sjogren's disease System Organ Class: 100000004859

Intervention(s)

Product Name: Nipocalimab
Product Code: M281
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: nipocalimab
CAS Number: 2211985-36-1
Current Sponsor code: M281
Other descriptive name: JNJ-80202135
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Main Objective: To evaluate the efficacy of nipocalimab in participants with primary Sjogren’s syndrome
(pSS) versus placebo

Primary end point(s): Change from baseline in Clinical European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (clinESSDAI) score at Week 24

Timepoint(s) of evaluation of this end point: Baseline to week 24

Secondary Objective: - To evaluate the safety of nipocalimab
treatment versus placebo in participants with
pSS

- To evaluate the pharmacokinetics (PK) and
immunogenicity of nipocalimab in
participants with pSS

- To evaluate the effect of nipocalimab versus
placebo on levels of serum biomarkers related
to pSS

Secondary Outcome(s)

Secondary end point(s): 1. Change from baseline in EULAR Sjögren Syndrome Patient Reported Index (ESSPRI) score at Week 24
2. Improvement of =4 points from baseline in EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) score (minimal clinically important improvement) at Week 24
3. Improvement of =4 points from baseline in clinESSDAI score (minimal clinically important improvement) at Week 24
4. ESSPRI response at Week 24
5. Disease response according to the STAR composite score at Week 24
6. Improvement in disease activity level by =1 level in at least one clinESSDAI or ESSDAI domain at Week 24
7. Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)
8. Percentage of Participants with Adverse Events of Special interests (AESIs)
9. Percentage of Participants with Treatment-emergent Serious Adverse Events (SAEs)
10. Percentage of Participants with Clinically Significant Abnormalities in Vital Signs
11. Percentage of Participants with Clinically Significant Abnormalities in Laboratory Parameters
12. Serum Concentration of Nipocalimab Over Time
13. Number of Participants with Antibodies to Nipocalimab (Anti-drug Antibodies [ADAs] and Neutralizing Antibodies [NAbs])
14. Number of Participants with Change from Baseline in Biomarkers
15. Number of Participants with Change from Baseline in Autoantibodies
16. Percentage of Participants with TEAEs leading to treatment discontinuation

Timepoint(s) of evaluation of this end point: secondary endpoint 1-6 at week 24
secondary endpoint 8,10,11,13, up to 36 weeks
secondary endpoint 7,9,12,16 up to 30 weeks
secondary endpoint 14-15 baseline to week 36

Secondary ID(s)

80202135SJS2001

2021-000665-32-DE

Source(s) of Monetary Support

Janssen Research & Development, LLC

Ethics review

Status: Approved
Approval date: 16/02/2022
Contact:

Results

• Results available: Yes
• Date Posted: 10/11/2024
• Date Completed: 30/11/2023
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-000665-32/results