Trial · NCT03843125
A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)
NCT03843125, Phase 3, Terminated, Eli Lilly and Company; results first posted 2023-05-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE). Trials, record NCT03843125. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03843125
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)
- NCT number
- NCT03843125
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,147 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Baricitinib, Placebo
- First posted
- 2019-02-15
- Last updated
- 2023-05-16
- Other registries' IDs
- eudract:2017-005028-11
- Results first posted
- 2023-05-16
- Limitations and caveats
- This study was terminated due to insufficient evidence to support a positive benefit: risk profile. Safety findings were consistent with previously published OLUMIANT data.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Week 134 | Percentage of participants with TEAEs. A treatment-emergent AE (TEAE) is defined as an event that first occurred or worsened in severity after the first dose of study treatment in Study JAIM and on or prior to the last visit date during the analysis period. The analysis period is defined as the treatment period plus up to 30 days off-drug follow-up time. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. |
| Primary | Percentage of Participants With Adverse Events of Special Interest (AESIs) | Week 134 | Percentage of Participants with AESIs. AESI consisted of infections, positively adjudicated arterial thromboembolic events (ATE), positively adjudicated venous thromboembolic events (VTE), positively adjudicated major adverse cardiovascular events (MACE), other positively adjudicated cardiovascular events, death, anaphylactic reactions, hypersensitivity, angioedema, and malignancies. |
| Primary | Percentage of Participants With Serious Adverse Events (SAEs) | Week 134 | Percentage of participants with SAEs. An SAE is any AE from this study that results in one of the following outcomes: Death; Initial or prolonged inpatient hospitalization; A life-threatening experience (that is, immediate risk of dying); Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important medical events that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the patient or may require intervention to prevent one of the other outcomes listed in the definition above. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section. |
| Primary | Percentage of Participants With Temporary Investigational Product Interruptions | Week 134 | Percentage of participants with temporary investigational product interruptions. |
| Primary | Percentage of Participants With Permanent Investigational Product Discontinuations | Week 134 | Percentage of participants with permanent investigational product discontinuations. |
| Secondary | Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response | Week 134 | SRI-4 response defined as 1)greater than or equal to 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score 2)no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score and 3)no worsening in Physician Global Assessment (PGA) of Disease Activity (worsening defined as an increase of \>=0.3 from baseline on a 0-3 visual analogue scale). SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms,or laboratory parameters related to Systemic Lupus Erythematosus (SLE),divided into 9 organ systems. For each organ system A=severe disease,B=moderate disease,C=mild stable disease,D=inactive,but previously active,E=inactive and never affected. PGA assesses disease activity on a visual analogue scale from 0 to 3 (1=mild, 2=moderate, 3=severe). |
| Secondary | Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS) | Week 48 | Percentage of participants achieving a LLDAS. The LLDAS is a composite measure designed to identify patients achieving a state of low disease activity. The LLDAS response criteria were: (1) SLEDAI-2K \<=4, with no activity in major organ systems (CNS, vascular, renal, cardiorespiratory and constitutional); where "no activity" is defined as all items of SLEDAI-2K within these major organ systems equal to 0. (2) no new features of lupus disease activity compared to previous occurred visit, where the "new feature" is defined as any of the SLEDAI-2K 24 items changed from 0 to greater than 0; (3) PGA (scale 0-3), \<=1; (4) current prednisolone (or equivalent) dose \<=7.5 mg daily. |
| Secondary | Change From Baseline in Prednisone Dose | Baseline through Week 48 | Change from baseline in prednisone dose. |
| Secondary | Annualized Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index Flare Rate | Baseline through Week 48 | The SELENA-SLEDAI tool is a cumulative and weighted index used to assess disease activity across 24 different disease descriptors in patients with lupus. A patient's SELENA-SLEDAI total score is the sum of all marked lupus related descriptors (seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, cerebrovascular accident, vasculitis, arthritis, myositis, urinary casts, hematuria, proteinuria, pyuria, new rash, alopecia, mucosal ulcers, pleurisy, pericarditis, low complement, increased DNA binding, fever, thrombocytopenia, leukopenia). A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity. The annualized flare rate is calculated as the number of flares divided by the flare exposure time in days multiplied with 365.25. |
| Secondary | Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Total Activity Score ≥10 at Baseline With ≥50% Reduction in CLASI Total Activity Score | Week 48 | The CLASI is a single-page tool that separately quantifies disease activity and damage. For the activity score, points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. The total score represents the sum of the individual scores and ranges from 0 to 70. Higher scores are awarded for more severe manifestations. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Week 134 | All participants who received at least one dose of study drug. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With Adverse Events of Special Interest (AESIs) | Week 134 | All participants who received at least one dose of study drug. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Serious Adverse Events (SAEs) | Week 134 | All participants who received at least one dose of study drug. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With Temporary Investigational Product Interruptions | Week 134 | All participants who received at least one dose of study drug. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With Permanent Investigational Product Discontinuations | Week 134 | All participants who received at least one dose of study drug. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response | Week 134 | All randomized participants who had SLEDAI-2K score of \>=4 at baseline. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS) | Week 48 | All participants who received at least one dose of study drug and had SLEDAI-2K score of \>=4 at baseline. Due to early termination of the study, this population consisted of participants who completed Week 48 treatment, or discontinued treatment prior to Week 48 (but not due to study termination). | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Prednisone Dose | Baseline through Week 48 | Due to early termination of the study, this population consisted of participants who completed Week 48 treatment, or discontinued treatment prior to Week 48 (but not due to study termination). Participants having values for this outcome were included. | milligrams (mg) | LEAST_SQUARES_MEAN |
| SECONDARY | Annualized Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index Flare Rate | Baseline through Week 48 | Due to early termination of the study, this population consisted of participants who completed Week 48 treatment, or discontinued treatment prior to Week 48 (but not due to study termination). Participants having values for this outcome were included. | flares per year | NUMBER |
| SECONDARY | Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Total Activity Score ≥10 at Baseline With ≥50% Reduction in CLASI Total Activity Score | Week 48 | All participants with CLASI Total Activity Score \>= 10 at baseline. Due to early termination of the study, this population consisted of participants who completed Week 48 treatment, or discontinued treatment prior to Week 48 (but not due to study termination). | Percentage of participants | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group92
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | 2 mg Baricitinib | 61.9 | Percentage of Participants | ||
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | 4 mg Baricitinib | 68.8 | Percentage of Participants | ||
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Placebo to 2 mg Baricitinib | 65.1 | Percentage of Participants | ||
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Placebo to 4 mg Baricitinib | 64.4 | Percentage of Participants | ||
| Percentage of Participants With Adverse Events of Special Interest (AESIs) | 2 mg Baricitinib | Infections | 38.4 | Percentage of participants | |
| Percentage of Participants With Adverse Events of Special Interest (AESIs) | 4 mg Baricitinib | Infections | 42.1 | Percentage of participants | |
| Percentage of Participants With Adverse Events of Special Interest (AESIs) | Placebo to 2 mg Baricitinib | Infections | 36.5 | Percentage of participants | |
| Percentage of Participants With Adverse Events of Special Interest (AESIs) | Placebo to 4 mg Baricitinib | Infections | 35.1 | Percentage of participants | |
| Percentage of Participants With Adverse Events of Special Interest (AESIs) | 2 mg Baricitinib | Positively adjudicated ATE | 0.3 | Percentage of participants | |
| Percentage of Participants With Adverse Events of Special Interest (AESIs) | 4 mg Baricitinib | Positively adjudicated ATE | 0.8 | Percentage of participants |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 2 Milligrams (mg) Baricitinib | 388 | |
| Overall Study | STARTED | 4 mg Baricitinib | 379 | |
| Overall Study | STARTED | Placebo to 2 mg Baricitinib | 189 | |
| Overall Study | STARTED | Placebo to 4 mg Baricitinib | 191 | |
| Overall Study | Safety Population | 2 Milligrams (mg) Baricitinib | 388 | |
| Overall Study | Safety Population | 4 mg Baricitinib | 378 | |
| Overall Study | Safety Population | Placebo to 2 mg Baricitinib | 189 | |
| Overall Study | Safety Population | Placebo to 4 mg Baricitinib | 191 | |
| Overall Study | COMPLETED | 2 Milligrams (mg) Baricitinib | 0 | |
| Overall Study | COMPLETED | 4 mg Baricitinib | 0 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events556
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Covid-19 | Infections and infestations | 2 mg Baricitinib | 35 | 388 | 35 |
| other | Covid-19 | Infections and infestations | 4 mg Baricitinib | 32 | 378 | 33 |
| other | Covid-19 | Infections and infestations | Placebo to 2 mg Baricitinib | 21 | 189 | 22 |
| other | Covid-19 | Infections and infestations | Placebo to 4 mg Baricitinib | 23 | 191 | 25 |
| other | Urinary tract infection | Infections and infestations | 2 mg Baricitinib | 20 | 388 | 28 |
| other | Urinary tract infection | Infections and infestations | 4 mg Baricitinib | 22 | 378 | 27 |
| other | Urinary tract infection | Infections and infestations | Placebo to 2 mg Baricitinib | 17 | 189 | 19 |
| other | Urinary tract infection | Infections and infestations | Placebo to 4 mg Baricitinib | 7 | 191 | 8 |
| serious | Immune thrombocytopenia | Blood and lymphatic system disorders | 2 mg Baricitinib | 1 | 388 | 1 |
| serious | Immune thrombocytopenia | Blood and lymphatic system disorders | 4 mg Baricitinib | 0 | 378 | 0 |
1 to 10 of 556Source ClinicalTrials.gov
See all 556 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 2 mg Baricitinib | 0 | 388 |
| Total, all-cause mortality | 4 mg Baricitinib | 6 | 378 |
| Total, all-cause mortality | Placebo to 2 mg Baricitinib | 2 | 189 |
| Total, all-cause mortality | Placebo to 4 mg Baricitinib | 0 | 191 |
| Total, other adverse events | 2 mg Baricitinib | 54 | 388 |
| Total, other adverse events | 4 mg Baricitinib | 54 | 378 |
| Total, other adverse events | Placebo to 2 mg Baricitinib | 35 | 189 |
| Total, other adverse events | Placebo to 4 mg Baricitinib | 29 | 191 |
| Total, serious adverse events | 2 mg Baricitinib | 43 | 388 |
| Total, serious adverse events | 4 mg Baricitinib | 53 | 378 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03843125
GET https://conductscience.org/api/trials/v1/NCT03843125/results?page=2