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New drug MK-1045 enters early human testing for lupus and RA

NCT ID NCT07363590

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 15, 2026 · Updated 6 times

Summary

This early study tests a new medicine, MK-1045, in about 21 people with lupus or rheumatoid arthritis. The main goal is to see if it is safe and tolerable at different dose levels. Participants receive the drug through an IV infusion, and researchers monitor for side effects.

What this could mean

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

Active substance
MK-1045 (also called CN201), given as an IV infusion
What this could lead to
If this early study shows MK-1045 is safe, it could lead to a new treatment option for people with lupus or rheumatoid arthritis.
What could go wrong
This is a very small, early-phase trial focused on safety, not effectiveness. The drug may not work or could have side effects. It will take years before any treatment might be available.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 21 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Jul 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 75 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.

Inclusion Criteria: * Has a body mass index between 18 and 32 kg/m\^2, inclusive * Systemic lupus erythematosus (SLE): Has a diagnosis of SLE for at least 6 months and met the European Alliance of Associations for Rheumatology (EULAR)/ American College of Rheumatology (ACR) 2019 classification criteria * SLE: Is taking at least one background therapy for SLE * RA: Has a diagnosis of RA for at least 6 months and meets the 2010 ACR-EULAR classification criteria for RA Exclusion Criteria: * Has a known active infection (excluding fungal infection of nail beds), or any major episode of infection requiring hospitalization or treatment with anti-infectives within 8 weeks prior to the Day 1 dosing * History of serious recurrent or chronic infection * Is known to be infected with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus * Has evidence of active tuberculosis (TB), latent TB, or inadequately treated TB * Has a significant or uncontrolled medical disease in any organ system not related to RA or SLE * For RA participants, has a history of any arthritis with onset before age 17 years * Has a current inflammatory condition other than SLE or RA that could interfere with disease activity assessments * History of cancer (except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \<5 years before Day 1 dosing * Has had a major surgery within 3 months prior to Screening or has a major surgery planned during the study. * Has symptomatic heart failure (New York Heart Association class III or IV) or myocardial infarction or unstable angina pectoris within 6 months prior to Screening * Has a severe chronic pulmonary disease requiring oxygen therapy * Has current active lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease

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Conditions

The condition(s) this trial relates to.

rheumatoid arthritis systemic lupus erythematosus

As listed by the trial registrant

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

Rheumatoid arthritis Systemic lupus erythematosus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    21 sites in 11 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • ARENSIA Clinics ( Site 0902)

    RECRUITING

    Bucharest, Bucharest, 011658, Romania

  • ARENSIA Exploratory Medicine-Country Emergency Hospital- Arensia,Cluj-Napoca ( Site 0901)

    RECRUITING

    Cluj-Napoca, Cluj, 400006, Romania

  • Anima Diepenbeek ( Site 0601)

    RECRUITING

    Diepenbeek, Limburg, 3590, Belgium

  • Arensia Exploartory Medicine ( Site 1301)

    RECRUITING

    Tbilisi, 0112, Georgia

  • Chinese Academy of Medical Science Peking Union Medical College Hospital ( Site 1501)

    RECRUITING

    Beijing, Beijing Municipality, 100005, China

  • Chulalongkorn University ( Site 0501)

    RECRUITING

    Pathumwan, Bangkok, 10330, Thailand

  • Clinica San Juan Bautista ( Site 0203)

    RECRUITING

    Lima, 15419, Peru

  • Clinica de la Costa S.A.S. ( Site 0101)

    RECRUITING

    Barranquilla, Atlántico, 080020, Colombia

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1901)

    RECRUITING

    Roma, 00168, Italy

  • Fundacion Valle del Lili ( Site 0102)

    RECRUITING

    Cali, Valle del Cauca Department, 760032, Colombia

  • Gold Coast University Hospital ( Site 1601)

    RECRUITING

    Southport, Queensland, 4215, Australia

  • Istituto Clinico Humanitas- IRCCS ( Site 1902)

    RECRUITING

    Rozzano, Milano, 20089, Italy

  • Keio University Hospital ( Site 0302)

    RECRUITING

    Shinjyuku, Tokyo, 160-8582, Japan

  • Oncomédica S.A.S ( Site 0103)

    RECRUITING

    Montería, Departamento de Córdoba, 230002, Colombia

  • PMSI Republican Clinical Hospital "T.Mosneaga" ( Site 1001)

    RECRUITING

    Chisinau, 2025, Moldova

  • Ramathibodi Hospital ( Site 0503)

    RECRUITING

    Ratchathewi, Bangkok, 10400, Thailand

  • Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1505)

    RECRUITING

    Shanghai, Shanghai Municipality, 200001, China

  • The First Affiliated Hospital of Henan University of Science &Technology ( Site 1502)

    RECRUITING

    Luoyang, Henan, 471003, China

  • The University of Tokyo Hospital ( Site 0301)

    RECRUITING

    Bunkyo, Tokyo, 113-8655, Japan

  • UZ Gent ( Site 0602)

    RECRUITING

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1504)

    RECRUITING

    Wuhan, Hubei, 430058, China

More trials for these conditions

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