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Fewer needle sticks? study tests larger injector for autoimmune drug

NCT ID NCT06293365

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests if a new 2mL auto-injector or pre-filled syringe delivers the same amount of the drug ianalumab into the body as the current 1mL syringe. About 155 adults with rheumatoid arthritis, Sjögren's disease, or lupus will receive the drug both ways to compare how much gets absorbed. The goal is to see if the larger device works just as well, which could mean fewer injections for patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ianalumab
What this could lead to
If successful, this could make it easier for patients to receive their medication with fewer injections, improving convenience and comfort.
What could go wrong
This is a small, early-phase study focused on drug levels, not on whether the drug itself works for the disease. The results may not change treatment or guarantee better outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

155 people

The number who actually took part.

Started

Jul 2024

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion criteria: * Signed informed consent must be obtained before any assessment is performed. * Male and female patients aged 18 years to 70 years (inclusive). * Body weight at least 35 kg and not more than 150 kg and must have a body mass index (BMI) within the range of 18 - 35 kg/m2. BMI = Body weight (kg) / \[Height (m)\]2 at screening. * Diagnosed with RA, SjD and/or SLE as determined by the investigator. * Have active disease (RA, SjD or SLE) that may benefit from B-cell depletion therapy, as determined by the investigator. * Participants currently receiving protocol-allowed SoC should be on stable doses of SoC medications for 4 weeks prior to first dosing of study treatment. * Ability to communicate well with the investigator, understand and agree to comply with the requirements of the study. Key Exclusion criteria: * Use of prohibited therapies. * Active viral, bacterial or other infections requiring systemic treatment at the time of screening or baseline or history of recurrent clinically significant infection. * Plans for administration of live vaccines during the study period. * Uncontrolled co-existing serious disease. * Pregnant or nursing (lactating) women. * Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, refusing or unable to use highly effective methods of contraception while on study treatment and for 6 months after stopping of study drug. * US (and other countries, if locally required): sexually active males unless using barrier protection during intercourse with women of child-bearing potential while taking study treatment. Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

rheumatoid arthritis Sjogren syndrome systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rheumatoid arthritis Sjögrens disease Systemic lupus erythematosus

Contacts and locations

Locations

  • Advanced Medical Research

    La Palma, California, 90623, United States

  • Advanced Rheumatology of Houston

    Spring, Texas, 77382, United States

  • Ahmed Arif Medical Research Center

    Grand Blanc, Michigan, 48439, United States

  • Altoona Center for Clin Res

    Duncansville, Pennsylvania, 16635, United States

  • Conquest Research

    Winter Park, Florida, 32789, United States

  • Indiana Univ School of Dentistry

    Indianapolis, Indiana, 46202, United States

  • Novartis Investigative Site

    Quilmes, Buenos Aires, 1878, Argentina

  • Novartis Investigative Site

    San Miguel Tucuman, Tucumán Province, T4000DPK, Argentina

  • Novartis Investigative Site

    Buenos Aires, 1646, Argentina

  • Novartis Investigative Site

    Buenos Aires, C1055AAF, Argentina

  • Novartis Investigative Site

    Hamilton, Ontario, L8N 3Z5, Canada

  • Novartis Investigative Site

    Toronto, Ontario, M5T 2S8, Canada

  • Novartis Investigative Site

    Rimouski, Quebec, G5L 5T1, Canada

  • Novartis Investigative Site

    Trois-Rivières, Quebec, G9A 3Y2, Canada

  • Novartis Investigative Site

    Brno, 638 00, Czechia

  • Novartis Investigative Site

    Prague, 128 00, Czechia

  • Novartis Investigative Site

    Uherské Hradiště, 686 01, Czechia

  • Novartis Investigative Site

    Debrecen, Hajdu Bihar Megye, 4032, Hungary

  • Novartis Investigative Site

    Budapest, 1027, Hungary

  • Novartis Investigative Site

    Budapest, 1134, Hungary

  • Novartis Investigative Site

    Salerno, SA, 84131, Italy

  • Novartis Investigative Site

    Krakow, 30-002, Poland

  • Novartis Investigative Site

    Lublin, 20-607, Poland

  • Novartis Investigative Site

    Santiago Compostela, A Coruna, 15706, Spain

  • Novartis Investigative Site

    A Coruña, 15006, Spain

  • Novartis Investigative Site

    Madrid, 28034, Spain

  • Novel Research LLC

    Bellaire, Texas, 77401, United States

  • Ochsner Health System

    Baton Rouge, Louisiana, 70809, United States

  • Paramount Med Rsrch and Consult LLC

    Middleburg Heights, Ohio, 44130, United States

  • Parris and Associates Rheumatology

    Lawrenceville, Georgia, 30044, United States

  • Pinnacle Research Group Llc

    Anniston, Alabama, 36207, United States

  • Providence Medical Foundation

    Fullerton, California, 92835, United States

  • RAO Research LLC

    Oklahoma City, Oklahoma, 73116, United States

  • Shelby Research LLC

    Memphis, Tennessee, 38119, United States

  • Southwest Rheum Rsrch LLC

    Mesquite, Texas, 75150, United States

  • Uni of Texas Health Science Center

    San Antonio, Texas, 78229, United States

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.