NTR-1011 for SLE and RA: initial safety testing in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, phase 1a/b interventional study in healthy volunteers and adults with SLE or RA to characterize safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of NTR-1011, a fusion protein designed to clear NETs. Phase 1a established initial safety and dose–response in healthy participants receiving single ascending doses by IV or subcutaneous injection. Phase 1b (LIBERATE-I) continues to evaluate safety and tolerability, plus PK/PD and preliminary efficacy signals in patients, to determine the highest safe dose and how the drug behaves in the body. The mechanism targets neutrophil extracellular traps to potentially reduce inflammatory activity in autoimmune disease. The study compares NTR-1011 to placebo in the controlled portions and monitors immune responses and early clinical signals of benefit when used with standard therapy.

Why it matters

Who can join: the full rules

Phase 1a - Healthy Volunteers (Completed, No Longer Enrolling)

Key Inclusion Criteria

* Healthy men and women, 18-55 years of age
* Body mass index (BMI) between 17.0 and 30.0 kg/m²
* Good general health, confirmed by medical history, physical exam, vital signs, ECG, and lab testing
* Willing and able to use highly effective contraception during and after the study

Key Exclusion Criteria

* Pregnant or breastfeeding
* History of drug allergies or anaphylaxis to human, murine, or yeast proteins, monoclonal antibodies, or other allergens
* Use of an investigational drug within 30 days (or 5 half-lives) before dosing
* Positive test for hepatitis B, hepatitis C, or HIV
* Clinically significant heart, lung, digestive, blood, autoimmune, psychiatric, or other medical condition
* Clinically significant abnormal lab values (e.g., liver enzymes, blood counts) or ECG findings
* Uncontrolled high blood pressure
* Poor venous access

Phase 1b - Adult Patients with SLE and RA (Actively Recruiting)

General Inclusion Criteria (All Patients)

* Men and women, 18-75 years of age
* Able to understand and sign informed consent, and comply with study visits
* Willing and able to use highly effective contraception during and after the study

Additional Inclusion Criteria - SLE Patients

* Diagnosis of SLE for at least 6 months, meeting 2019 EULAR/ACR classification criteria
* Active disease at screening
* Positive lupus-related antibodies (e.g., anti-dsDNA, anti-Smith) and low complement (C3/C4)
* On stable standard-of-care background therapy (e.g., antimalarials, low-dose corticosteroids, and at least one conventional DMARD)
* Up to date on age-appropriate vaccinations Additional Inclusion Criteria - RA Patients
* Diagnosis of RA for at least 3 months, meeting 2010 ACR/EULAR classification criteria
* Moderate-to-severe active disease
* Seropositive for rheumatoid factor and/or anti-CCP antibodies
* On stable standard-of-care background therapy (e.g., low-dose corticosteroids and at least one conventional DMARD)

Key Exclusion Criteria (All Patients)

* Pregnant or breastfeeding
* Known allergy or reaction to NTR-1011, placebo components, or related products
* Use of an investigational drug within 30 days (or 5 half-lives) before dosing, or concurrent enrollment in another clinical trial
* History of cancer within the past year (with limited exceptions)
* Significant kidney impairment, severe liver dysfunction, or severe lung disease
* Uncontrolled high blood pressure or significant cardiovascular disease (e.g., recent heart attack or stroke, certain arrhythmias)
* Active, recurrent, or high-risk infection, including active or latent tuberculosis without appropriate treatment, opportunistic infections, or chronic hepatitis B
* Recent symptoms of COVID-19 without a documented negative test
* Receipt of a live vaccine within 4 weeks before screening or planned within 4 weeks after last dose
* Significant central nervous system disease or pain-amplification conditions (e.g., epilepsy, fibromyalgia) that could interfere with study assessments
* Major surgery within 8 weeks before screening or planned within 6 months after baseline
* History of bone marrow, stem cell, or solid organ transplant (except cornea)
* Uncontrolled diabetes within the past 12 months (with some exceptions)
* History of a blood clot within the past 12 months (with some exceptions)
* Clinically significant abnormal lab values (e.g., liver enzymes, blood counts) at screening

Where it's running

• Carewell Arthritis Center
  Apple Valley, California, United States Recruiting
• Attune Health Research Inc
  Beverly Hills, California, United States Recruiting
• Covina Arthritis Clinic
  Covina, California, United States Recruiting
• Novamed
  Monterey Park, California, United States Recruiting
• Southland Arthritis Clinic
  Riverside, California, United States Recruiting
• Southland Arthritis Clinic
  Temecula, California, United States Recruiting

Study contacts

• Study coordinator: Andreas Reiff, MD, PhD
• Email: reiff@neutrolis.com
• Phone: (626) 264-2734

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.