Systemic Lupus ErythematosusPhase 1/2QSITNCT07221565
Electromagnetic Immunotherapy Mapping and Cytokine Forecasting Study (QSIT)
A Phase 1/2 study testing Low-Frequency Electromagnetic Resonance Therapy (LF-EMR) and Low-Dose Naltrexone (LDN) in people with Systemic Lupus Erythematosus and Rheumatoid Arthritis, run by Truway Health, Inc. at 1 site in United States.
Trial summary
The ImmuneNet study is a Phase I/II clinical trial sponsored by Truway Health, Inc. It will test whether gentle, low-frequency electromagnetic resonance (LF-EMR) can influence how immune cells communicate and synchronize with each other. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Systemic Lupus Erythematosus, Rheumatoid Arthritis, Multiple Sclerosis
- What is being tested?
- Low-Frequency Electromagnetic Resonance Therapy (LF-EMR) and Low-Dose Naltrexone (LDN)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2025to 23 Oct 2034
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female participants aged 18-70 years.
- Clinical diagnosis of a systemic autoimmune disorder (e.g., systemic lupus erythematosus, rheumatoid arthritis, or multiple sclerosis) confirmed for at least 12 months.
- Stable disease-modifying therapy or corticosteroid regimen for at least 8 weeks prior to enrollment.
- Willingness to maintain current medication schedule for the duration of the study.
- Ability to provide written informed consent and comply with study procedures.
- Access to stable internet or smartphone connection for digital consent verification and symptom tracking.
Who cannot join
- Presence of an implanted medical or electronic device (e.g., pacemaker, defibrillator, deep brain stimulator).
- Pregnancy or lactation.
- Active infection, malignancy, or significant hepatic, renal, or cardiovascular disease.
- Known photosensitivity, seizure disorder, or history of uncontrolled epilepsy.
- Prior participation in any electromagnetic or quantum resonance study within the past 6 months.
- Use of biologic or investigational therapy initiated within the previous 3 months.
- Inability to attend at least 80% of treatment sessions or follow-up visits.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Truway Health, Inc. www.truwayhealth.com (401 E 34th Street, S11P, New York, NY 10016)
New York, New York, 10016
About this study
Official title: ImmuneNet: Quantum-Synaptic Immunotherapy Mapping
The ImmuneNet study is a Phase I/II clinical trial sponsored by Truway Health, Inc. It will test whether gentle, low-frequency electromagnetic resonance (LF-EMR) can influence how immune cells communicate and synchronize with each other. The goal is to see if this "quantum-synaptic" signaling effect can help stabilize immune activity and reduce the number of autoimmune flare-ups in people living with conditions such as lupus, rheumatoid arthritis, or multiple sclerosis.
Participants will receive either an active or a sham (placebo) LF-EMR session three times per week for twelve weeks. Each session is completely non-invasive. Blood samples will be collected to study cytokines (immune-system messenger molecules), gene-expression patterns, and electrical field coherence among immune cells.
Read more
A machine-learning system will analyze these data to predict inflammation patterns and guide individualized treatment settings. All participant data will be securely recorded and time-stamped to ensure transparency and privacy.
The expected outcome of the study is a measurable reduction in autoimmune flare frequency and symptom severity, along with improved understanding of how electromagnetic signaling might safely regulate immune function.
Read the detailed description
This exploratory, randomized, double-blind, parallel-assignment Phase I/II trial is designed to evaluate the safety, tolerability, and biological activity of low-frequency electromagnetic resonance (LF-EMR) for immune modulation.
Rationale and Objectives Autoimmune diseases involve abnormal immune signaling that leads to chronic inflammation. Emerging biophysical evidence suggests that immune cells generate and respond to ultra-low-frequency electromagnetic fields that may coordinate cytokine release and cell communication. The ImmuneNet protocol seeks to harness this phenomenon through controlled, resonant electromagnetic exposure to promote immune homeostasis.
Methods Approximately 120 adults aged 18-70 with stable autoimmune disease will be enrolled at Truway Health Research Centers in New York, NY and Austin, TX. Participants will be randomly assigned in a 1:1 ratio to active or sham LF-EMR stimulation. Active participants will receive 7-40 Hz resonant fields (< 2 microtesla) for 20 minutes per session, three times weekly for twelve weeks. Sham participants will undergo identical procedures with the device inactive.
Blood samples collected at baseline, week 6, week 12, and six-month follow-up will undergo multiplex cytokine analysis, RNA sequencing, and electrophysiologic coherence mapping. Machine-learning models will be trained to forecast cytokine cascades and flare probability.
Outcome Measures The primary endpoint is reduction in documented autoimmune flare frequency over six months. Secondary endpoints include changes in serum cytokine synchronization index, transcriptomic shift magnitude, patient-reported global health scores, and adverse-event incidence.
Ethics and Oversight The study will follow Good Clinical Practice (GCP) guidelines and be reviewed by an independent institutional review board. Participation is voluntary, and informed consent will be obtained from all subjects.
Expected Impact If successful, the trial will demonstrate a safe, non-pharmacologic approach to immune regulation and establish a data framework for future AI-guided quantum-resonant therapies. The knowledge gained could lead to new treatment options for autoimmune and chronic inflammatory diseases while reducing reliance on long-term immunosuppressive drugs.
- Conditions
- Systemic Lupus Erythematosus, Rheumatoid Arthritis, Multiple Sclerosis, Autoimmune Diseases, Chronic Inflammatory Syndromes, Immune Dysregulation
- Being tested
- Low-Frequency Electromagnetic Resonance Therapy (LF-EMR), Sham Resonance Device (Inactive Control), Low-Dose Naltrexone (LDN)
- Keywords
- Quantum Immunotherapy, Electromagnetic Resonance Therapy, Low-Frequency Electromagnetic Fields, Immune Cell Synchronization, Cytokine Forecasting, AI-Driven Immunomodulation, Truway Health ClinicalChain, Non-pharmacologic Immune Regulation, Autoimmune Flare Reduction, Machine Learning in Immunology
- Medical subject headings
- Lupus Erythematosus, Systemic, Arthritis, Rheumatoid, Multiple Sclerosis, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Frequency Electromagnetic Resonance Therapy (LF-EMR)Device
Also called Quantum-Synaptic Resonance Device (QSR-01)
A non-invasive medical device that generates low-frequency electromagnetic fields (7-40 Hz < 2 μT) targeted at harmonizing immune-cell electromagnetic communication. Participants receive 20-minute sessions three times weekly for twelve weeks. The device is cleared for investigational use under Truway Health protocol TWH-QSIT-IMMUNENET-2025-01.
Sham Resonance Device (Inactive Control)Device
Also called Placebo LF-EMR Unit
A visually identical device programmed to remain inactive and emit no electromagnetic field. Used to maintain blinding and assess placebo response. Participants follow the same treatment schedule as the active group.
Low-Dose Naltrexone (LDN)Drug
Also called Naltrexone Hydrochloride, 4.5 mg oral capsule
Participants assigned to this adjunct pharmacologic arm will receive low-dose naltrexone (4.5 mg oral capsule once daily at bedtime) for twelve weeks.
Low-dose naltrexone is hypothesized to reduce pro-inflammatory cytokine activity and enhance endogenous endorphin-mediated immune regulation. The dose is well below the standard 50 mg level used for addiction therapy and has been studied for autoimmune and inflammatory disorders.
This arm will allow assessment of potential synergy between electromagnetic-resonance signaling and pharmacologic immune modulation.
Manufacturer / Source:
Compounded formulation supplied by Truway Health Clinical Pharmacy, New York, NY (cGMP-certified).
Route of Administration:
Oral (capsule)
Dosage Form:
Capsule, 4.5 mg
Frequency / Duration:
Once daily for 12 weeks
Intended Use:
Investigational immune-modulating therapy to complement non-pharmacologic intervention.
| Study group | Role | What they receive |
|---|---|---|
| Active Low-Frequency Electromagnetic Resonance (LF-EMR) | Experimental | Participants in the experimental arm will receive non-invasive low-frequency electromagnetic resonance (LF-EMR) therapy three times per week for twelve weeks. Each session uses a calibrated emitter producing resonant fields between 7-40 Hz at amplitudes below 2 microtesla. The treatment is designed to promote synchronized signaling among immune effector cells and reduce autoimmune flare frequency. Receives: Device: Low-Frequency Electromagnetic Resonance Therapy (LF-EMR); Device: Sham Resonance Device (Inactive Control); Drug: Low-Dose Naltrexone (LDN) |
| Sham Electromagnetic Stimulation (Placebo Control) | Sham comparator | Participants in the control arm will undergo identical procedures with a deactivated (sham) LF-EMR device that emits no measurable electromagnetic field. This arm controls for placebo and procedural effects. Neither participants nor investigators will know which device is active or inactive. Receives: Device: Low-Frequency Electromagnetic Resonance Therapy (LF-EMR); Device: Sham Resonance Device (Inactive Control); Drug: Low-Dose Naltrexone (LDN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Autoimmune Flare Frequency
Number of clinically confirmed autoimmune flare events during the 6-month observation period compared to baseline, using validated disease-specific scoring systems (e.g., SLEDAI for lupus, DAS-28 for rheumatoid arthritis, or EDSS for multiple sclerosis).
Measured: Baseline to Month 6
Secondary outcomes (1)
Cytokine Synchronization Index (CSI)
Change in cytokine synchronization index (CSI) calculated from multiplex cytokine panels (IL-6, TNF-α, IFN-γ, IL-10) using Fourier-transformed oscillatory coherence values between cytokine pairs.
Measured: Baseline, Week 12, and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2025
- Study start23 Oct 2025
- Primary completion23 Oct 2034 (estimated)
- Study completion23 Oct 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to receive either active low-frequency electromagnetic resonance therapy or sham stimulation. Each arm follows the same 12-week schedule. Outcomes are compared across parallel groups to evaluate immune-regulation effects.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Truway Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gavin Solomon, President & CEO, Principal investigator, Truway Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221565
- Sponsor's protocol ID
- TWH-QSIT-IMMUNENET-2025-01
- Acronym
- QSIT
- Status last verified
- May 2026
- First submitted
- 23 Oct 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be made available for secondary research analyses following publication of primary results. Shared data will include participant-level demographics, clinical outcomes, cytokine panels, and RNA sequencing results. Data will be accessible via the Truway Health ClinicalChain Data Repository, a blockchain-secured storage and access system ensuring traceable data integrity and compliance with HIPAA and GDPR standards. Access requests may be submitted to Truway Health, Inc. (help@truwayhealth.com) and will be reviewed by the sponsor's Data Access Committee. Researchers must provide a data use proposal and agree to a data-sharing agreement. IPD will become available approximately 12 months after study completion and remain available for a minimum of 5 years following initial publication.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ImmuneNet: Quantum-Synaptic Immunotherapy Mapping
- ClinicalTrials.gov ID
- NCT07221565
- Acronym / sponsor ID
- QSIT / TWH-QSIT-IMMUNENET-2025-01
- Conditions
- Systemic Lupus Erythematosus, Rheumatoid Arthritis, Multiple Sclerosis, Autoimmune Diseases, Chronic Inflammatory Syndromes, Immune Dysregulation
- Keywords
- Quantum Immunotherapy, Electromagnetic Resonance Therapy, Low-Frequency Electromagnetic Fields, Immune Cell Synchronization, Cytokine Forecasting, AI-Driven Immunomodulation, Truway Health ClinicalChain, Non-pharmacologic Immune Regulation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Truway Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- 23 Oct 2034 (estimated)
- Study completion
- 23 Oct 2034 (estimated)
- First posted
- 28 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ImmuneNet study is a Phase I/II clinical trial sponsored by Truway Health, Inc. It will test whether gentle, low-frequency electromagnetic resonance (LF-EMR) can influence how immune cells communicate and synchronize with each other. The goal is to see if this "quantum-synaptic" signaling effect can help stabilize immune activity and reduce the number of autoimmune flare-ups in people living with conditions such as lupus, rheumatoid arthritis, or multiple sclerosis.
Participants will receive either an active or a sham (placebo) LF-EMR session three times per week for twelve weeks. Each session is completely non-invasive. Blood samples will be collected to study cytokines (immune-system messenger molecules), gene-expression patterns, and electrical field coherence among immune cells.
A machine-learning system will analyze these data to predict inflammation patterns and guide individualized treatment settings. All participant data will be securely recorded and time-stamped to ensure transparency and privacy.
The expected outcome of the study is a measurable reduction in autoimmune flare frequency and symptom severity, along with improved understanding of how electromagnetic signaling might safely regulate immune function.
Detailed description
This exploratory, randomized, double-blind, parallel-assignment Phase I/II trial is designed to evaluate the safety, tolerability, and biological activity of low-frequency electromagnetic resonance (LF-EMR) for immune modulation.
Rationale and Objectives Autoimmune diseases involve abnormal immune signaling that leads to chronic inflammation. Emerging biophysical evidence suggests that immune cells generate and respond to ultra-low-frequency electromagnetic fields that may coordinate cytokine release and cell communication. The ImmuneNet protocol seeks to harness this phenomenon through controlled, resonant electromagnetic exposure to promote immune homeostasis.
Methods Approximately 120 adults aged 18-70 with stable autoimmune disease will be enrolled at Truway Health Research Centers in New York, NY and Austin, TX. Participants will be randomly assigned in a 1:1 ratio to active or sham LF-EMR stimulation. Active participants will receive 7-40 Hz resonant fields (< 2 microtesla) for 20 minutes per session, three times weekly for twelve weeks. Sham participants will undergo identical procedures with the device inactive.
Blood samples collected at baseline, week 6, week 12, and six-month follow-up will undergo multiplex cytokine analysis, RNA sequencing, and electrophysiologic coherence mapping. Machine-learning models will be trained to forecast cytokine cascades and flare probability.
Outcome Measures The primary endpoint is reduction in documented autoimmune flare frequency over six months. Secondary endpoints include changes in serum cytokine synchronization index, transcriptomic shift magnitude, patient-reported global health scores, and adverse-event incidence.
Ethics and Oversight The study will follow Good Clinical Practice (GCP) guidelines and be reviewed by an independent institutional review board. Participation is voluntary, and informed consent will be obtained from all subjects.
Expected Impact If successful, the trial will demonstrate a safe, non-pharmacologic approach to immune regulation and establish a data framework for future AI-guided quantum-resonant therapies. The knowledge gained could lead to new treatment options for autoimmune and chronic inflammatory diseases while reducing reliance on long-term immunosuppressive drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to receive either active low-frequency electromagnetic resonance therapy or sham stimulation. Each arm follows the same 12-week schedule. Outcomes are compared across parallel groups to evaluate immune-regulation effects.
| Arm | Type | Receives |
|---|---|---|
| Active Low-Frequency Electromagnetic Resonance (LF-EMR) | Experimental | Device: Low-Frequency Electromagnetic Resonance Therapy (LF-EMR), Device: Sham Resonance Device (Inactive Control), Drug: Low-Dose Naltrexone (LDN)Participants in the experimental arm will receive non-invasive low-frequency electromagnetic resonance (LF-EMR) therapy three times per week for twelve weeks. Each session uses a calibrated emitter producing resonant fields between 7-40 Hz at amplitudes below 2 microtesla. The treatment is designed to promote synchronized signaling among immune effector cells and reduce autoimmune flare frequency. |
| Sham Electromagnetic Stimulation (Placebo Control) | Sham comparator | Device: Low-Frequency Electromagnetic Resonance Therapy (LF-EMR), Device: Sham Resonance Device (Inactive Control), Drug: Low-Dose Naltrexone (LDN)Participants in the control arm will undergo identical procedures with a deactivated (sham) LF-EMR device that emits no measurable electromagnetic field. This arm controls for placebo and procedural effects. Neither participants nor investigators will know which device is active or inactive. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female participants aged 18-70 years.
- Clinical diagnosis of a systemic autoimmune disorder (e.g., systemic lupus erythematosus, rheumatoid arthritis, or multiple sclerosis) confirmed for at least 12 months.
- Stable disease-modifying therapy or corticosteroid regimen for at least 8 weeks prior to enrollment.
- Willingness to maintain current medication schedule for the duration of the study.
- Ability to provide written informed consent and comply with study procedures.
Key exclusion criteria (7 listed)
- Presence of an implanted medical or electronic device (e.g., pacemaker, defibrillator, deep brain stimulator).
- Pregnancy or lactation.
- Active infection, malignancy, or significant hepatic, renal, or cardiovascular disease.
- Known photosensitivity, seizure disorder, or history of uncontrolled epilepsy.
- Prior participation in any electromagnetic or quantum resonance study within the past 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Frequency Electromagnetic Resonance Therapy (LF-EMR)Also: Quantum-Synaptic Resonance Device (QSR-01)A non-invasive medical device that generates low-frequency electromagnetic fields (7-40 Hz < 2 μT) targeted at harmonizing immune-cell electromagnetic communication. Participants receive 20-minute sessions three times weekly for twelve weeks. The device is cleared for investigational use under Truway Health protocol TWH-QSIT-IMMUNENET-2025-01. | Device | Active Low-Frequency Electromagnetic Resonance (LF-EMR), Sham Electromagnetic Stimulation (Placebo Control) |
| Sham Resonance Device (Inactive Control)Also: Placebo LF-EMR UnitA visually identical device programmed to remain inactive and emit no electromagnetic field. Used to maintain blinding and assess placebo response. Participants follow the same treatment schedule as the active group. | Device | Active Low-Frequency Electromagnetic Resonance (LF-EMR), Sham Electromagnetic Stimulation (Placebo Control) |
| Low-Dose Naltrexone (LDN)Also: Naltrexone Hydrochloride, 4.5 mg oral capsuleParticipants assigned to this adjunct pharmacologic arm will receive low-dose naltrexone (4.5 mg oral capsule once daily at bedtime) for twelve weeks. Low-dose naltrexone is hypothesized to reduce pro-inflammatory cytokine activity and enhance endogenous endorphin-mediated immune regulation. The dose is well below the standard 50 mg level used for addiction therapy and has been studied for autoimmune and inflammatory disorders. This arm will allow assessment of potential synergy between electromagnetic-resonance signaling and pharmacologic immune modulation. Manufacturer / Source: Compounded formulation supplied by Truway Health Clinical Pharmacy, New York, NY (cGMP-certified). Route of Administration: Oral (capsule) Dosage Form: Capsule, 4.5 mg Frequency / Duration: Once daily for 12 weeks Intended Use: Investigational immune-modulating therapy to complement non-pharmacologic intervention. | Drug | Active Low-Frequency Electromagnetic Resonance (LF-EMR), Sham Electromagnetic Stimulation (Placebo Control) |
Primary outcome
Change in Autoimmune Flare Frequency
Time frame: Baseline to Month 6
Number of clinically confirmed autoimmune flare events during the 6-month observation period compared to baseline, using validated disease-specific scoring systems (e.g., SLEDAI for lupus, DAS-28 for rheumatoid arthritis, or EDSS for multiple sclerosis).
1 secondary outcome
Cytokine Synchronization Index (CSI)
Time frame: Baseline, Week 12, and Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Truway Health Official WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be made available for secondary research analyses following publication of primary results. Shared data will include participant-level demographics, clinical outcomes, cytokine panels, and RNA sequencing results. Data will be accessible via the Truway Health ClinicalChain Data Repository, a blockchain-secured storage and access system ensuring traceable data integrity and compliance with HIPAA and GDPR standards. Access requests may be submitted to Truway Health, Inc. (help@truwayhealth.com) and will be reviewed by the sponsor's Data Access Committee. Researchers must provide a data use proposal and agree to a data-sharing agreement. IPD will become available approximately 12 months after study completion and remain available for a minimum of 5 years following initial publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gavin Solomon, President & CEO principal investigator
Truway Health, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Low-Frequency Electromagnetic Resonance Therapy (LF-EMR) and Low-Dose Naltrexone (LDN) in people with Systemic Lupus Erythematosus and Rheumatoid Arthritis, run by Truway Health, Inc. at 1 site in United States.
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 6 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Autoimmune Flare Frequency (time frame: Baseline to Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026.