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

NCT04968912 | Completed Phase 2 DMC FDA Drug

• 3 other identifiers: CR10906280202135SJS20012021-000665-32
• Study Type: interventional
• Target: 163
• Locations: 10 countries
• Sites: 69

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of nipocalimab in participants with primary Sjogren's syndrome (pSS) versus placebo.

Conditions

Sjogren's Syndrome

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (clinESSDAI) Score at Week 24

  The clinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with primary Sjogren's syndrome. The clinESSDAI includes 11 domains divided into 3-4 activity levels, where zero represents no activity and low, medium, and high scores can vary in numerical value depending on the domain.

  Baseline to Week 24

Secondary Outcomes (17)

• Change from Baseline in European League Against Rheumatism (EULAR) Sjogren Syndrome Patient Reported Index (ESSPRI) Score at Week 24

  Baseline to Week 24

• Improvement of Greater than or Equal to (>=) 4 Points from Baseline in ESSDAI Score (Minimal Clinically Important Improvement) at Week 24

  Baseline to Week 24

• Improvement of >= 4 Points from Baseline in clinESSDAI Score (Minimal Clinically Important Improvement) at Week 24

  Baseline to Week 24

• ESSPRI Response at Week 24

  Week 24

• Disease Response as Assessed by Sjögren's Tool for Assessing Response (STAR) Composite Score at Week 24

  Week 24

Study Arms (3)

Group 1: Placebo

PLACEBO COMPARATOR

Participants will receive placebo intravenously (IV) every 2 weeks (q2w) through Week 22 along with standard of care treatments (\[including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues\], and/or one immunomodulator with or without low-dose glucocorticosteroids).

Other: Placebo; Drug: Standard of Care Treatment

Group 2: Nipocalimab Dose 1

EXPERIMENTAL

Participants will receive nipocalimab dose 1 IV q2w through Week 22 along with standard of care treatments (\[including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues\], and/or one immunomodulator with or without low-dose glucocorticosteroids).

Drug: Nipocalimab; Drug: Standard of Care Treatment

Group 3: Nipocalimab Dose 2

EXPERIMENTAL

Participants will receive nipocalimab dose 2 IV q2w through Week 22 along with standard of care treatments (\[including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues\], and/or one immunomodulator with or without low-dose glucocorticosteroids).

Drug: Nipocalimab; Drug: Standard of Care Treatment

Interventions

Placebo OTHER

Placebo infusion will be administered intravenously.

Group 1: Placebo

Nipocalimab DRUG

Nipocalimab dose 1 and dose 2 infusions will be administered intravenously.

Also known as: JNJ-80202135, M281

Group 2: Nipocalimab Dose 1; Group 3: Nipocalimab Dose 2

Standard of Care Treatment DRUG

Standard of care treatment including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues, and/or one immunomodulator with or without low-dose glucocorticosteroids will be administered topically/orally.

Group 1: Placebo; Group 2: Nipocalimab Dose 1; Group 3: Nipocalimab Dose 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 A \[SSA\])
• 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 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 regimen 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 participants receiving immune-targeted therapy will be followed when determining an appropriate interval between vaccination and study enrollment

You may not qualify if:

• 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 (for example, 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (69)

Anniston Medical Clinic

Anniston, Alabama, 36207, United States

Location

Arizona Arthritis and Rheumatology Research PLLC

Glendale, Arizona, 85306, United States

Location

Arizona Arthritis & Rheumatology Research, PLLC

Mesa, Arizona, 85210, United States

Location

St. Jude Heritage Medical Group

Fullerton, California, 92835, United States

Location

Inland Rheumatology Clinical Trials, Inc.

Upland, California, 91786, United States

Location

Colorado Arthritis Associates

Denver, Colorado, 80228, United States

Location

Denver Arthritis Clinic

Denver, Colorado, 80230, United States

Location

Rheumatology Associates Of South Florida

Boca Raton, Florida, 33486, United States

Location

Bay Area Arthritis and Osteoporosis

Brandon, Florida, 33511, United States

Location

Centre for Rheumatology, Immunology and Arthritis

Fort Lauderdale, Florida, 33309, United States

Location

University of Florida Health Jacksonville

Jacksonville, Florida, 32209, United States

Location

Omega Research Consultants

Orlando, Florida, 32835, United States

Location

Clinical Investigation Specialists

Gurnee, Illinois, 60031, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

St. Paul Rheumatology P A

Eagan, Minnesota, 55121, United States

Location

North Mississippi Medical Clinics

Tupelo, Mississippi, 38801, United States

Location

PMG Research of Salisbury

Salisbury, North Carolina, 28144, United States

Location

Altoona Center For Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Columbia Arthritis Center

Columbia, South Carolina, 29204, United States

Location

West Tennessee Research Institute

Jackson, Tennessee, 38305, United States

Location

Dr. Ramesh Gupta

Memphis, Tennessee, 38119, United States

Location

Austin Regional Clinic

Austin, Texas, 78731-3146, United States

Location

Trinity Clinical Research, LLC

Carrollton, Texas, 75007, United States

Location

CHU de Grenoble Hopital Albert Michallon

La Tronche, 38700, France

Location

Centre Hospitalier Le Mans

Le Mans, 72037, France

Location

Hopital Saint Joseph

Marseille, 13285, France

Location

Hopital Pitie Salpetriere

Paris, 75013, France

Location

CHRU Hôpital de Hautepierre

Strasbourg, 67098, France

Location

Charite Universitaetsmedizin Berlin

Berlin, 10117, Germany

Location

Uniklinik Köln

Cologne, 50923, Germany

Location

Universitatsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

Location

Hamburger Rheuma Forschungszentrum II

Hamburg, 20095, Germany

Location

medius KLINIK KIRCHHEIM

Kirchheim unter Teck, 73230, Germany

Location

Universitatsklinikum Tubingen

Tübingen, 72076, Germany

Location

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili

Brescia, 25123, Italy

Location

P.O. Vittorio Emanuele Azienda Ospedaliero Universitaria 'Policlinico Vittorio Emanuele'

Catania, 95100, Italy

Location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

Palermo, 90129, Italy

Location

Azienda Ospedaliera Universitaria Integrata Verona

Verona, 37126, Italy

Location

Tokyo Metropolitan Tama Medical Center

Fuchū, 183 8524, Japan

Location

Nagasaki University Hospital

Nagasaki, 852-8501, Japan

Location

Hokkaido University Hospital

Sapporo, 060-8648, Japan

Location

St. Luke's International Hospital

Tokyo, 104 8560, Japan

Location

Nihon University Itabashi Hospital

Tokyo, 173 8610, Japan

Location

University of Tsukuba Hospital

Tsukuba, 305-8520, Japan

Location

Medisch Centrum Leeuwarden

Leeuwarden, 8934 AD, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, 3015 GD, Netherlands

Location

Nasz Lekarz Przychodnie Medyczne

Bydgoszcz, 85-065, Poland

Location

Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy

Bydgoszcz, 85-168, Poland

Location

Zespolu Opieki Zdrowotnej w Konskich

Gmina Końskie, 26 200, Poland

Location

Malopolskie Badania Kliniczne Sp z o o

Krakow, 30-002, Poland

Location

REUMED Zespol Poradni Specjalistycznych Filia nr 2

Lublin, 20-607, Poland

Location

Centrum Medyczne

Poznan, 61 113, Poland

Location

Medycyna Kliniczna

Warsaw, 00-874, Poland

Location

Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher

Warsaw, 02 637, Poland

Location

Centrum Medyczne AMED Targowek

Warsaw, 03 291, Poland

Location

Centrum Medyczne Oporow

Wroclaw, 52 415, Poland

Location

Instituto Portugues de Reumatologia

Lisbon, 1050-034, Portugal

Location

ULSAM, EPE - Hospital Conde de Bertiandos

Ponte de Lima, 4990-078, Portugal

Location

Hosp Univ A Coruna

A Coruña, 15006, Spain

Location

Hosp Reina Sofia

Córdoba, 14004, Spain

Location

Hosp. de Merida

Mérida, 6800, Spain

Location

Corporacio Sanitari Parc Tauli

Sabadell, 08208, Spain

Location

Hosp Clinico Univ de Salamanca

Salamanca, 37007, Spain

Location

Hosp. Infanta Luisa

Seville, 41010, Spain

Location

Tri-Service General Hospital

Taipei, 11490, Taiwan

Location

Chang Gung Memorial Hospital Linkou Branch

Taoyuan District, 333, Taiwan

Location

Related Publications (1)

• Noaiseh G, Sivils KL, Campbell K, Idokogi J, Lo KH, Liva SG, Leu JH, Dhatt H, Ma K, Leonardo S, Li H, Hubbard JJ, Gottenberg JE. Efficacy and safety of nipocalimab in patients with moderate-to-severe Sjogren's disease (DAHLIAS): a randomised, phase 2, placebo-controlled, double-blind trial. Lancet. 2025 Nov 22;406(10518):2435-2448. doi: 10.1016/S0140-6736(25)01430-8. Epub 2025 Oct 24.

  PMID: 41284548 DERIVED

MeSH Terms

Conditions

Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 20, 2021
• Study Start: September 21, 2021
• Primary Completion: October 23, 2023
• Study Completion: November 30, 2023
• Last Updated: November 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

IT (5); ES (6); JP (6); DE (6); NL (2); FR (5); PL (10); TW (2); US (25); PT (2)