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Systemic Lupus ErythematosusPhase 2NCT05123586

A IMMA Master Protocol: A Study of LY3361237 in Participants With at Least Moderately Active Systemic Lupus Erythematosus

A Phase 2 study testing LY3361237 in people with Systemic Lupus Erythematosus, run by Eli Lilly and Company at 50 sites in 8 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The main purpose of this study is to assess the efficacy and safety of LY3361237 in participants with at least moderately active systemic lupus erythematosus (SLE). Study will last up to 34 weeks and may include up to 15 visits. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
LY3361237
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
85 participants
Where
50 sitesin 8 countries
Study dates
7 Mar 2022to 29 Dec 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Are diagnosed with SLE at least 24 weeks before Day 1 of study
  • Have documentation of having a score of 10 or more points on the European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria for SLE
  • Have a SLEDAI-2K score ≥6 at screening (Day 1) and clinical Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥4 (not including any items related to laboratory values) at randomization (Day 2)
  • Must be receiving at least 1 background standard-of-care medication for SLE

Who cannot join

  • Participants are excluded if they have received any of the following medications or therapies within the indicated timeframe prior to the randomization visit (Day 2).
  • Are currently receiving oral corticosteroids at doses >20 mg per day of prednisone (or equivalent) or have adjusted the dosage of corticosteroids within 2 weeks before starting study treatment
  • Have received parenteral corticosteroids within 12 weeks before starting study treatment or are expected to require parenteral corticosteroids during the study
  • Have a current or recent acute, active infection
  • Have had a serious, chronic, recurring conditions of herpes simplex, herpes zoster, recurring cellulitis, chronic osteomyelitis)
  • Have human immunodeficiency virus (HIV) infection, hepatitis B virus (HBV), hepatitis C infection (HCV), active tuberculosis (TB)
Show all 11Show fewer
  • Have active fibromyalgia or active occurrence of an inflammatory condition that, in the investigator's opinion, would make it difficult to appropriately assess SLE activity for the purposes of this study
  • Have experienced a cardiac event within 24 weeks to 12 months prior to screening
  • Have a history of clinically significant or uncontrolled illness that in the opinion of the investigator could put the participant at risk to participate in the study
  • Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide
  • Are pregnant or are intending to become pregnant or to breastfeed at any time in the study

Trial locations and contacts

50 sites in 8 countries.

50 sites in 8 countries

United States19 sites

  • Tekton Research, Inc

    Austin, Texas, 78745

  • Clinical Research of West Florida, Inc. (Clearwater)

    Clearwater, Florida, 33765

  • Qualmedica Research, LLC

    Evansville, Indiana, 47715

  • University of North Carolina

    Hillsborough, North Carolina, 27278

  • Rheumatology Center Of Houston

    Houston, Texas, 77004

  • Newport Huntington Med Grp

    Huntington Beach, California, 92648

  • Houston Rheumatology & Arthritis Specialists

    Katy, Texas, 77494

  • Atlanta Research Center for Rheumatology

    Marietta, Georgia, 30060

  • Arizona Arthritis & Rheumatology Associates, P. C.

    Mesa, Arizona, 85210

  • Ezy Medical Research

    Miami, Florida, 33175

  • Paramount Medical Research

    Middleburg Heights, Ohio, 44130

  • Tekton Research, Inc.

    Moore, Oklahoma, 73160

  • Arizona Arthritis & Rheumatology Associates

    Phoenix, Arizona, 85037

  • Desert Medical Advances

    Rancho Mirage, California, 92270

  • Clinvest Research LLC

    Springfield, Missouri, 65807

  • Arizona Arthritis & Rheumatology Research - Sun City

    Sun City, Arizona, 85351

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Clinical Research of West Florida

    Tampa, Florida, 33606

  • Tekton Research, Inc

    Wichita, Kansas, 67218

Other trials in United States

Argentina8 sites

  • APRILLUS Asistencia E Investigacion

    CABA, Ciudad Autónoma de Buenos Aire, 1046

  • APRILLUS Asistencia E Investigacion

    Ciudad Autónoma de Buenos Aire, 1406

  • DOM Centro de Reumatología

    Ciudad Autónoma de Buenos Aire, C1111

  • CENUDIAB

    Ciudad Autónoma de Buenos Aire, C1440AAD

  • Clínica Privada Independencia

    Munro, Buenos Aires

  • Centro de Investigaciones Médicas Tucuman

    SAN M. de Tucuman, Tucumán Province, T4000AXL

  • Instituto de Investigaciones Clinicas Zarate

    Zárate, Buenos Aires, B2800DGH

  • Instituto de Investigaciones Clinicas Zarate

    Zárate, Santa Fe Province, 2800

Other trials in Argentina

France4 sites

  • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

    Nantes, 44093

  • Centre Hospitalier Regional D'Orleans

    Orléans, Centre-Val de Loire, 45067

  • Nouvel Hôpital Civil (NHC)

    Strasbourg, Alsace, 67091

  • Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan

    Toulouse, Haute-Garo, 31059

Other trials in France

Mexico4 sites

  • Clinica de Investigacion en Reumatologia y Obesidad S. C.

    Guadalajara, Jalisco, 44650

  • Centro Medico del Angel

    Mexicali, Estado de Baja California, 21100

  • CIMAB SA de CV

    Torreón, Coahuila, 27000

  • Investigacion Biomedica para el Desarrollo de Fármacos S.A. de C.V.

    Zapopan, Jalisco, 45070

Other trials in Mexico

Poland4 sites

  • Nova Reuma Społka Partnerska

    Bialystok, Podlaskie Voivodeship, 15-707

  • Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168

  • Twoja Przychodnia Centrum Medyczne Nowa Sol

    Nowa Sól, Lubusz Voivodeship, 67-100

  • Twoja Przychodnia Poznanskie Centrum Medyczne

    Poznan, Greater Poland Voivodeship, 61-293

Other trials in Poland

Puerto Rico4 sites

  • Centro Reumatologico Caguas

    Caguas, PR, 00725

  • GCM Medical Group, PSC - Hato Rey Site

    San Juan, PR, 917

  • Latin Clinical Trial Center

    San Juan, 00909

  • Mindful Medical Research

    San Juan, 00918

Other trials in Puerto Rico

Taiwan4 sites

  • Chang Gung Memorial Hospital at Kaohsiung

    Kaohsiung Niao Sung Dist, Kaohsiung, 83301

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Tri-Service General Hospital

    Taipei City, Taipei, 114

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan City, Taoyuan, 333

Other trials in Taiwan

Czechia3 sites

  • Revmatologie.s.r.o.

    Brno, Brno-město, 63800

  • Artroscan, s.r.o.

    Ostrava, Moravian-Silesian Region, 722 00

  • Vseobecna fakultni nemocnice v Praze

    Prague, 12808

Other trials in Czechia

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Two-Arm, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of LY3361237 as a Treatment for Adults With At Least Moderately Active Systemic Lupus Erythematosus

The main purpose of this study is to assess the efficacy and safety of LY3361237 in participants with at least moderately active systemic lupus erythematosus (SLE). Study will last up to 34 weeks and may include up to 15 visits.

Being tested
LY3361237, Placebo
Keywords
Autoimmune Disease, BTLA B and T Lymphocyte attenuator, Immune checkpoint, Inhibitory checkpoint agonist antibody, Lupus
Medical subject headings
Lupus Erythematosus, Systemic, Autoimmune Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY3361237Drug

    Administered SC

  • PlaceboDrug

    Administered SC

Study groups in NCT05123586
Study groupRoleWhat they receive
LY3361237ExperimentalParticipants are administered LY3361237 subcutaneously (SC) and standard of care (SOC)
Receives: Drug: LY3361237
PlaceboPlacebo comparatorPlacebo administered SC and SOC given at matching intervals
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Arthritis and/or Rash at Baseline Who Achieve Remission of Arthritis and/or Rash

    Remission of arthritis and/or rash is defined by the following: if only arthritis is present at baseline, then the primary endpoint is met if arthritis is absent at Week 24; if only rash is present at baseline, then the primary endpoint is met if rash is absent at Week 24; if both arthritis and rash are present at baseline, then the primary endpoint is met if either arthritis, or rash, or both arthritis and rash are absent at Week 24.

    Measured: Week 24

Secondary outcomes (3)

  1. Percentage of Participants Who Achieve Systemic Lupus Erythematosus Disease Activity Index-4 (SLEDAI-4) Response

    Percentage of participants who achieved SLEDAI-4 response was assessed. A SLEDAI-4 response is defined as a ≥ 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score from baseline. The SLEDAI-2K score range is from a minimum of 0 to a maximum of 105 (higher scores represent higher disease activity).

    Measured: Week 24

  2. Percentage of Participants Who Achieve Systemic Lupus Erythematosus Responder Index-4 (SRI-4 Response)

    Percentage of participants who achieved SRI-4 response was assessed. SRI-4 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points [10 mm] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity.

    Measured: Week 24

  3. Pharmacokinetics (PK): Steady-state Trough Serum Concentration of LY3361237 at Week 24

    PK: Steady-state trough serum concentration of LY3361237 at Week 24 was assessed.

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2021
  2. Study start7 Mar 2022
  3. Primary completion29 Dec 2023
  4. Study completion29 Dec 2023

Why it stopped: Study terminated due to lack of efficacy

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05123586
Sponsor's protocol ID
18248
Other IDs
J1V-MC-BT01, 2021-001406-30
Status last verified
Dec 2024
First submitted
16 Nov 2021
Last updated
20 Jan 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY3361237 in people with Systemic Lupus Erythematosus, run by Eli Lilly and Company at 50 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States, Argentina, France, Mexico, Poland and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Arthritis and/or Rash at Baseline Who Achieve Remission of Arthritis and/or Rash (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05123586.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.

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