SLEPhase 1NCT02483624
3,3'-Diindolylmethane in Patients With Systemic Lupus Erythematosus
A Phase 1 study testing BR-DIM in people with SLE, run by Northwell Health.
Trial summary
This is a single center study of patients with inactive or mild SLE being performed to determine the safety, tolerability, and pharmacodynamics of DIM. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- SLE
- What is being tested?
- BR-DIM
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jan 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Stable SLE disease activity for a period of at least 2 months prior to the Screening visit, based on the clinical judgment of the investigators
- History of measurable anti-dsDNA, anti-Sm, RNP, SS-A (anti-Ro), or SS-B (anti-La) autoantibodies
- Age > 18 and < 50
- Ability to understand the requirements of the study, provide written consent, and comply with the study protocol procedures
- A negative pregnancy test
- The use of contraception by fertile females
Show all 9Show fewer
- A serum creatinine <1.8 mg/dL
- Serum hepatic transaminases < 1.25 times the upper limits of normal
- Hemoglobin > 9.5, WBC > 3.0, neutrophils > 1.2; platelets > 90,000
Who cannot join
- Immunosuppressive therapy (e.g. cyclophosphamide, cyclosporine, azathioprine, mycophenolate mofetil) or intravenous gamma globulin within 6 months of study entry
- Prior receipt of biologic agents, unless 9 months or 4 half-lives, whichever is greater, have passed since the last dose
- Prednisone > 10 mg/day (or its pharmacologic equivalent) within 2 months of randomization
- Pregnancy or the intent to conceive during the study or 3 months after study completion
- Concurrent medications such as danazol, DHEA, or other medications that affect estrogen levels or metabolism
- Nursing mothers
Show all 16Show fewer
- Oral contraceptive use
- The presence of infection
- A history of poor procedural compliance
- Receipt of an investigational drug within 60 days of baseline
- Malignancy (except for basal cell carcinoma)
- Dose changes of steroids, anti-malarial drugs, or NSAID's within 4 weeks of randomization
- Peri- or post-menopausal state
- History of clinical evidence of active significant acute or chronic diseases (i.e., cardiovascular, pulmonary, untreated hypertension, anemia, gastrointestinal, hepatic, renal, neurological, cancer, or infectious diseases) that could confound the results of the study or put the subject at undue risk
- History of any other medical disease, laboratory abnormalities, or conditions that would make the subject (in the opinion of the investigators) unsuitable for the study
- Current drug or alcohol addiction
About this study
Official title: A Single-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of 3,3'-Diindolylmethane (BR-DIM) in Patients With Systemic Lupus Erythematosus (SLE)
This is a single center study of patients with inactive or mild SLE being performed to determine the safety, tolerability, and pharmacodynamics of DIM.
Read the detailed description
This study is a single-blinded, placebo-controlled trial to determine the effects of DIM supplementation in patients with SLE. The DIM supplement to be used is BioResponse-DIM® (BR-DIM®), an absorption-enhanced formulation of proven bioavailability in animal testing and human trials. A total of 30 individuals will be enrolled into this 14-month study. Ten patients will be randomly assigned to the Low Dose Group [a daily dose of 225 mg of DIM from BR-DIM]. Ten patients will be randomly assigned to the High Dose Group [a daily dose of 375 mg of DIM from BR-DIM]. Ten patients will be randomly assigned to a matching placebo group, where 5 of these patients will receive matched placebo capsules equaling use in the Low Dose active group, and 5 will receive matched placebo equaling use in the High Dose active group. Each active capsule will deliver 75 mg of DIM from BR-DIM. Dosing will span 52 weeks. BR-DIM or comparably packaged placebo will be administered orally with meals twice per day. Placebo subjects randomized to the Low Dose group will take 2 placebo capsules in the am and 1 capsule in the pm and placebo subjects randomized to the high dose group will take 3 capsules in the am and 2 capsules in the pm. Low Dose active subjects will take 2 capsules in the am and 1 capsule in the pm. High Dose active subjects will take 3 capsules in the am and 2 capsules in the pm. Study subjects will be randomly assigned to one of the four treatment groups. Randomization procedures will be overseen by the staff of the North Shore Long Island Jewish General Clinical Research Center. The randomization schedule will be set up by the Bio-Statistics unit. The Investigator will contact the Research Pharmacy at North Shore University Hospital who will contact the Bio-Statistics unit once the subject signs the Informed Consent Form in order to learn which treatment regimen the subject is assigned to. Patients and control subjects will be given the appropriate amount of study medication at each visit to take home with them. Study personnel will monitor compliance by asking the patient to return any unused study medication at each visit for drug accountability. In addition, medication logs will be kept by the study subject and will be presented to the study coordinator at each visit. The subject, but not study personnel, will be blinded to the study drug assignments.
- Conditions
- SLE
- Being tested
- BR-DIM, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BR-DIMDrug
Also called 3,3'-diindolylmethane
DIM, a condensation product of indole-3-carbinol (IC3), is a phytochemical that has activity against certain tumor cells. Observations in lupus-prone mice treated with indole-3-carbinol suggest that DIM might have favorable biologic and clinical effects in human SLE.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Experimental | 10 patients 225 mg of BR-DIM. 2 capsules AM and 1 PM. 52 weeks duration. Receives: Drug: BR-DIM |
| High Dose | Experimental | 10 patients 375 mg of BR-DIM. 3 capsules AM and 2 PM. 52 weeks duration. Receives: Drug: BR-DIM |
| Placebo | Placebo comparator | 10 patients receiving weight matched placebo. 5 for high dose and 5 for low dose. 52 weeks of weight matched pills. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability Routine clinical and laboratory parameters as well as SLE activity measurement with SELENA Systemic Lupus Erythematosus Disease Activity Index assessment.
Routine clinical and laboratory parameters as well as SLE activity measurement with SELENA Systemic Lupus Erythematosus Disease Activity Index assessment.
Measured: 14 months
Estradiol Hydroxylation Pathways
Measure alterations in the ratio of 2-hydroxyestrone/ 16alpha-hydroxyestrone (2-OHE/16alpha-OHE) in the urine.
Measured: 14 months
Autoantibody Production
Routine lab testing to determine whether DIM supplementation will decrease autoantibody production
Measured: 14 Months
T and B Lymphocytes
Qualitative and quantitative abnormalities in B- and T-lymphocytes abound in human SLE. In this aim, phenotypic analyses of B- and T-lymphocyte subsets as well as functional analyses will be ascertained in order to evaluate the effects of DIM on these parameters.
Measured: 14 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for SLEStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Furie, MD, Principal investigator, NorthShore-LIJ Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483624
- Sponsor's protocol ID
- 06.02.107T
- Status last verified
- Jan 2016
- First submitted
- 23 Jun 2015
- Last updated
- 1 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Roubinian JR, Talal N, Greenspan JS, Goodman JR, Siiteri PK. Effect of castration and sex hormone treatment on survival, anti-nucleic acid antibodies, and glomerulonephritis in NZB/NZW F1 mice. J Exp Med. 1978 Jun 1;147(6):1568-83. doi: 10.1084/jem.147.6.1568.
PubMed 308087Roubinian J, Talal N, Siiteri PK, Sadakian JA. Sex hormone modulation of autoimmunity in NZB/NZW mice. Arthritis Rheum. 1979 Nov;22(11):1162-9. doi: 10.1002/art.1780221102. No abstract available.
PubMed 508370Carlsten H, Nilsson N, Jonsson R, Backman K, Holmdahl R, Tarkowski A. Estrogen accelerates immune complex glomerulonephritis but ameliorates T cell-mediated vasculitis and sialadenitis in autoimmune MRL lpr/lpr mice. Cell Immunol. 1992 Oct 1;144(1):190-202. doi: 10.1016/0008-8749(92)90236-i.
PubMed 1394437Petri M. Exogenous estrogen in systemic lupus erythematosus: oral contraceptives and hormone replacement therapy. Lupus. 2001;10(3):222-6. doi: 10.1191/096120301676707393.
PubMed 11315357Bradlow HL, Telang NT, Sepkovic DW, Osborne MP. 2-hydroxyestrone: the 'good' estrogen. J Endocrinol. 1996 Sep;150 Suppl:S259-65.
PubMed 8943806Swaneck GE, Fishman J. Covalent binding of the endogenous estrogen 16 alpha-hydroxyestrone to estradiol receptor in human breast cancer cells: characterization and intranuclear localization. Proc Natl Acad Sci U S A. 1988 Nov;85(21):7831-5. doi: 10.1073/pnas.85.21.7831.
PubMed 3186693Lahita RG, Bradlow HL, Kunkel HG, Fishman J. Increased 16 alpha-hydroxylation of estradiol in systemic lupus erythematosus. J Clin Endocrinol Metab. 1981 Jul;53(1):174-8. doi: 10.1210/jcem-53-1-174.
PubMed 7240374Michnovicz JJ, Bradlow HL. Altered estrogen metabolism and excretion in humans following consumption of indole-3-carbinol. Nutr Cancer. 1991;16(1):59-66. doi: 10.1080/01635589109514141.
PubMed 1656396Bradlow HL, Michnovicz J, Telang NT, Osborne MP. Effects of dietary indole-3-carbinol on estradiol metabolism and spontaneous mammary tumors in mice. Carcinogenesis. 1991 Sep;12(9):1571-4. doi: 10.1093/carcin/12.9.1571.
PubMed 1893517Michnovicz JJ, Adlercreutz H, Bradlow HL. Changes in levels of urinary estrogen metabolites after oral indole-3-carbinol treatment in humans. J Natl Cancer Inst. 1997 May 21;89(10):718-23. doi: 10.1093/jnci/89.10.718.
PubMed 9168187Chen DZ, Qi M, Auborn KJ, Carter TH. Indole-3-carbinol and diindolylmethane induce apoptosis of human cervical cancer cells and in murine HPV16-transgenic preneoplastic cervical epithelium. J Nutr. 2001 Dec;131(12):3294-302. doi: 10.1093/jn/131.12.3294.
PubMed 11739883Rosen CA, Woodson GE, Thompson JW, Hengesteg AP, Bradlow HL. Preliminary results of the use of indole-3-carbinol for recurrent respiratory papillomatosis. Otolaryngol Head Neck Surg. 1998 Jun;118(6):810-5. doi: 10.1016/S0194-5998(98)70274-8.
PubMed 9627242Bell MC, Crowley-Nowick P, Bradlow HL, Sepkovic DW, Schmidt-Grimminger D, Howell P, Mayeaux EJ, Tucker A, Turbat-Herrera EA, Mathis JM. Placebo-controlled trial of indole-3-carbinol in the treatment of CIN. Gynecol Oncol. 2000 Aug;78(2):123-9. doi: 10.1006/gyno.2000.5847.
PubMed 10926790Auborn KJ, Qi M, Yan XJ, Teichberg S, Chen D, Madaio MP, Chiorazzi N. Lifespan is prolonged in autoimmune-prone (NZB/NZW) F1 mice fed a diet supplemented with indole-3-carbinol. J Nutr. 2003 Nov;133(11):3610-3. doi: 10.1093/jn/133.11.3610.
PubMed 14608082Theofilopoulos AN, Dixon FJ. Murine models of systemic lupus erythematosus. Adv Immunol. 1985;37:269-390. doi: 10.1016/s0065-2776(08)60342-9. No abstract available.
PubMed 3890479
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of 3,3'-Diindolylmethane (BR-DIM) in Patients With Systemic Lupus Erythematosus (SLE)
- ClinicalTrials.gov ID
- NCT02483624
- Acronym / sponsor ID
- 06.02.107T
- Conditions
- SLE
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 29 Jun 2015 (estimated)
- 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.
This is a single center study of patients with inactive or mild SLE being performed to determine the safety, tolerability, and pharmacodynamics of DIM.
Detailed description
This study is a single-blinded, placebo-controlled trial to determine the effects of DIM supplementation in patients with SLE. The DIM supplement to be used is BioResponse-DIM® (BR-DIM®), an absorption-enhanced formulation of proven bioavailability in animal testing and human trials. A total of 30 individuals will be enrolled into this 14-month study. Ten patients will be randomly assigned to the Low Dose Group [a daily dose of 225 mg of DIM from BR-DIM]. Ten patients will be randomly assigned to the High Dose Group [a daily dose of 375 mg of DIM from BR-DIM]. Ten patients will be randomly assigned to a matching placebo group, where 5 of these patients will receive matched placebo capsules equaling use in the Low Dose active group, and 5 will receive matched placebo equaling use in the High Dose active group. Each active capsule will deliver 75 mg of DIM from BR-DIM. Dosing will span 52 weeks. BR-DIM or comparably packaged placebo will be administered orally with meals twice per day. Placebo subjects randomized to the Low Dose group will take 2 placebo capsules in the am and 1 capsule in the pm and placebo subjects randomized to the high dose group will take 3 capsules in the am and 2 capsules in the pm. Low Dose active subjects will take 2 capsules in the am and 1 capsule in the pm. High Dose active subjects will take 3 capsules in the am and 2 capsules in the pm. Study subjects will be randomly assigned to one of the four treatment groups. Randomization procedures will be overseen by the staff of the North Shore Long Island Jewish General Clinical Research Center. The randomization schedule will be set up by the Bio-Statistics unit. The Investigator will contact the Research Pharmacy at North Shore University Hospital who will contact the Bio-Statistics unit once the subject signs the Informed Consent Form in order to learn which treatment regimen the subject is assigned to. Patients and control subjects will be given the appropriate amount of study medication at each visit to take home with them. Study personnel will monitor compliance by asking the patient to return any unused study medication at each visit for drug accountability. In addition, medication logs will be kept by the study subject and will be presented to the study coordinator at each visit. The subject, but not study personnel, will be blinded to the study drug assignments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Experimental | Drug: BR-DIM10 patients 225 mg of BR-DIM. 2 capsules AM and 1 PM. 52 weeks duration. |
| High Dose | Experimental | Drug: BR-DIM10 patients 375 mg of BR-DIM. 3 capsules AM and 2 PM. 52 weeks duration. |
| Placebo | Placebo comparator | Drug: Placebo10 patients receiving weight matched placebo. 5 for high dose and 5 for low dose. 52 weeks of weight matched pills. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Stable SLE disease activity for a period of at least 2 months prior to the Screening visit, based on the clinical judgment of the investigators
- History of measurable anti-dsDNA, anti-Sm, RNP, SS-A (anti-Ro), or SS-B (anti-La) autoantibodies
- Age > 18 and < 50
- Ability to understand the requirements of the study, provide written consent, and comply with the study protocol procedures
- A negative pregnancy test
Key exclusion criteria (16 listed)
- Immunosuppressive therapy (e.g. cyclophosphamide, cyclosporine, azathioprine, mycophenolate mofetil) or intravenous gamma globulin within 6 months of study entry
- Prior receipt of biologic agents, unless 9 months or 4 half-lives, whichever is greater, have passed since the last dose
- Prednisone > 10 mg/day (or its pharmacologic equivalent) within 2 months of randomization
- Pregnancy or the intent to conceive during the study or 3 months after study completion
- Concurrent medications such as danazol, DHEA, or other medications that affect estrogen levels or metabolism
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 |
|---|---|---|
| BR-DIMAlso: 3,3'-diindolylmethaneDIM, a condensation product of indole-3-carbinol (IC3), is a phytochemical that has activity against certain tumor cells. Observations in lupus-prone mice treated with indole-3-carbinol suggest that DIM might have favorable biologic and clinical effects in human SLE. | Drug | High Dose, Low Dose |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Safety and Tolerability Routine clinical and laboratory parameters as well as SLE activity measurement with SELENA Systemic Lupus Erythematosus Disease Activity Index assessment.
Time frame: 14 months
Routine clinical and laboratory parameters as well as SLE activity measurement with SELENA Systemic Lupus Erythematosus Disease Activity Index assessment.
Estradiol Hydroxylation Pathways
Time frame: 14 months
Measure alterations in the ratio of 2-hydroxyestrone/ 16alpha-hydroxyestrone (2-OHE/16alpha-OHE) in the urine.
Autoantibody Production
Time frame: 14 Months
Routine lab testing to determine whether DIM supplementation will decrease autoantibody production
T and B Lymphocytes
Time frame: 14 Months
Qualitative and quantitative abnormalities in B- and T-lymphocytes abound in human SLE. In this aim, phenotypic analyses of B- and T-lymphocyte subsets as well as functional analyses will be ascertained in order to evaluate the effects of DIM on these parameters.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2016.
- Background: PubMed 308087Roubinian JR, Talal N, Greenspan JS, Goodman JR, Siiteri PK. Effect of castration and sex hormone treatment on survival, anti-nucleic acid antibodies, and glomerulonephritis in NZB/NZW F1 mice. J Exp Med. 1978 Jun 1;147(6):1568-83. doi: 10.1084/jem.147.6.1568.
- Background: PubMed 508370Roubinian J, Talal N, Siiteri PK, Sadakian JA. Sex hormone modulation of autoimmunity in NZB/NZW mice. Arthritis Rheum. 1979 Nov;22(11):1162-9. doi: 10.1002/art.1780221102. No abstract available.
- Background: PubMed 1394437Carlsten H, Nilsson N, Jonsson R, Backman K, Holmdahl R, Tarkowski A. Estrogen accelerates immune complex glomerulonephritis but ameliorates T cell-mediated vasculitis and sialadenitis in autoimmune MRL lpr/lpr mice. Cell Immunol. 1992 Oct 1;144(1):190-202. doi: 10.1016/0008-8749(92)90236-i.
- Background: PubMed 11315357Petri M. Exogenous estrogen in systemic lupus erythematosus: oral contraceptives and hormone replacement therapy. Lupus. 2001;10(3):222-6. doi: 10.1191/096120301676707393.
- Background: PubMed 8943806Bradlow HL, Telang NT, Sepkovic DW, Osborne MP. 2-hydroxyestrone: the 'good' estrogen. J Endocrinol. 1996 Sep;150 Suppl:S259-65.
- Background: PubMed 3186693Swaneck GE, Fishman J. Covalent binding of the endogenous estrogen 16 alpha-hydroxyestrone to estradiol receptor in human breast cancer cells: characterization and intranuclear localization. Proc Natl Acad Sci U S A. 1988 Nov;85(21):7831-5. doi: 10.1073/pnas.85.21.7831.
- Background: PubMed 7240374Lahita RG, Bradlow HL, Kunkel HG, Fishman J. Increased 16 alpha-hydroxylation of estradiol in systemic lupus erythematosus. J Clin Endocrinol Metab. 1981 Jul;53(1):174-8. doi: 10.1210/jcem-53-1-174.
- Background: PubMed 1656396Michnovicz JJ, Bradlow HL. Altered estrogen metabolism and excretion in humans following consumption of indole-3-carbinol. Nutr Cancer. 1991;16(1):59-66. doi: 10.1080/01635589109514141.
- Background: PubMed 1893517Bradlow HL, Michnovicz J, Telang NT, Osborne MP. Effects of dietary indole-3-carbinol on estradiol metabolism and spontaneous mammary tumors in mice. Carcinogenesis. 1991 Sep;12(9):1571-4. doi: 10.1093/carcin/12.9.1571.
- Background: PubMed 9168187Michnovicz JJ, Adlercreutz H, Bradlow HL. Changes in levels of urinary estrogen metabolites after oral indole-3-carbinol treatment in humans. J Natl Cancer Inst. 1997 May 21;89(10):718-23. doi: 10.1093/jnci/89.10.718.
- Background: PubMed 11739883Chen DZ, Qi M, Auborn KJ, Carter TH. Indole-3-carbinol and diindolylmethane induce apoptosis of human cervical cancer cells and in murine HPV16-transgenic preneoplastic cervical epithelium. J Nutr. 2001 Dec;131(12):3294-302. doi: 10.1093/jn/131.12.3294.
- Background: PubMed 9627242Rosen CA, Woodson GE, Thompson JW, Hengesteg AP, Bradlow HL. Preliminary results of the use of indole-3-carbinol for recurrent respiratory papillomatosis. Otolaryngol Head Neck Surg. 1998 Jun;118(6):810-5. doi: 10.1016/S0194-5998(98)70274-8.
Related trials for SLE
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Recruiting
Effect of Anti-inflammatory Diet in Systemic Lupus Erythematous
Systemic Lupus Erthematosus (SLE)
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
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. This study is not recruiting at the moment.
Richard Furie, MD principal investigator
NorthShore-LIJ Health System
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BR-DIM in people with SLE, run by Northwell Health.
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 9 inclusion and 16 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: stopped early, as of the sponsor's last update on 1 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Safety and Tolerability Routine clinical and laboratory parameters as well as SLE activity measurement with SELENA Systemic Lupus Erythematosus Disease Activity Index assessment. (time frame: 14 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02483624, which also lists 17 linked publications.
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 1 Feb 2016.