Is NCT07237659 recruiting in Covina, CA?

Yes, NCT07237659 is currently recruiting participants at its Covina, CA location. This sle (systemic lupus) clinical trial is actively enrolling qualified participants.

How do I join the sle (systemic lupus) clinical trial in Covina?

To join this clinical trial in Covina, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Covina clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

SLE (Systemic Lupus) Clinical Trial in Covina, CA

About This SLE (Systemic Lupus) Study in Covina

The goal of this clinical trial is to inform the safety and tolerability of NTR-1011 in treating adult patients diagnosed with systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA). It will also learn about the safety of NTR-1011 in healthy adult volunteers. The main questions it aims to answer are: * What is the highest dose of NTR-1011 that is safe and well tolerated, when given under the skin or into a vein? * How does the body process NTR-1011, and how does NTR-1011 affect the body? * Does the body develop an immune response to NTR-1011? * Are there early signs that NTR-1011 may benefit patients with SLE or RA when added to their current standard-of-care treatment? In the first part of the study (Phase 1a, now complete), researchers compared single doses of NTR-1011 to a placebo (a look-alike substance that contains no drug) in 48 healthy volunteers to see how the body tolerates and processes the drug. In the current part of the study (Phase 1b, actively recruiting), all participants receive NTR-1011 in addition to their usual SLE or RA treatment; there is no placebo group. Up to 24 participants with moderate-to-severe SLE or RA will: * Receive five weekly doses of NTR-1011 given directly into a vein (intravenous) * Continue their current standard-of-care treatment throughout the study * Be monitored for 4 weeks after their last dose * Be assigned to either the SLE group or the RA group (up to 12 patients each)

Sponsor: Neutrolis

Who Can Participate

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Covina?

Yes, this clinical trial (NCT07237659) has an active research site in Covina, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

SLE (Systemic Lupus) Treatment Options in Covina, CA

If you're searching for sle (systemic lupus) treatment options in Covina, CA, this clinical trial (NCT07237659) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Covina research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced sle (systemic lupus) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all sle (systemic lupus) clinical trials near you to find additional studies recruiting in your area.

SLE (Systemic Lupus) Clinical Trial in Covina, CA

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