SLE study: NTR1011
Official title Phase 1a/b Tolerability of NTR-1011 in Healthy Adults and Adult Patients With SLE and RA
ClinicalTrials.gov ID: NCT07237659
What this study is testing
What is NTR1011?
NTR1011 is an investigational medicine being studied as a potential treatment for systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find the safest dose of NTR-1011 and see how the body handles it. It also looks for early signs that the drug might help with lupus or rheumatoid arthritis.
- Who it's for
- The study is looking for healthy adults, as well as adults with moderate-to-severe lupus or rheumatoid arthritis.
- What's involved
- Participants will receive five weekly doses of NTR-1011 through an IV (a tube into a vein) while continuing their usual treatments. Researchers will monitor your health and check how your body reacts to the drug.
- Time commitment
- The study involves five weekly visits for treatment, followed by four weeks of monitoring after the last dose.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Phase 1a - Healthy Volunteers (Completed, No Longer Enrolling) Key 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
You likely can't join if
- 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
See the full eligibility criteria
- Phase 1a - Healthy Volunteers (Completed, No Longer Enrolling) Key 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Apple Valley, California, United States
- Beverly Hills, California, United States
- Covina, California, United States
- Monterey Park, California, United States
- Riverside, California, United States
- Temecula, California, United States
- Tujunga, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Apple Valley, California, United States; Beverly Hills, California, United States; Covina, California, United States; Monterey Park, California, United States; Riverside, California, United States; Temecula, California, United States and 1 more location. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.