anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ezetimibe
Trial phase: Phase 2
ATC code: C10AX09 | C10BA02 | C10BA05 | C10BA06 | C10BA10 | C10BA11 | C10BA12
SMILES: [H][C@]1(CC[C@H](O)c2ccc(F)cc2)C(=O)N(c2ccc(F)cc2)[C@]1([H])c1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: 20mg/day ezetimibe

20mg ezetimibe: Participants assigned to this intervention will receive 20mg per day of ezetimibe for 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Males/females 18 - 70 yrs of age
Serum HCV RNA >2,000 IU/ml
Hepatitis C genotype 1
Other causes of chronic liver disease excluded by appropriate clinical, laboratory, or histologic evaluation

The following hematological criteria must be met:

Hemoglobin > 12 g/dl
Absolute neutrophil count (ANC) > 1.0x109 /L
Platelets 150 x 108 /L (i.e normal)
Serum creatinine <1.5 times the upper limit of normal (ULN) at screening.
Fasting blood sugar normal for non-diabetics or hemoglobin A1C < 8.5% with diabetes
Women of childbearing potential must have a negative pregnancy test prior to receiving treatment. Sexually active women must take adequate precautions to prevent pregnancy during the study. Pregnancy tests will be done at the final clinic visits and every 4 weeks
Patient provides written informed consent

Exclusion Criteria:

Evidence of liver disease other than HCV:

Antinuclear antibodies (ANA) >1:160
Active alcoholic liver disease.
Hepatitis B surface antigen positive
Hemochromatosis
Wilson disease
Alpha-1-antitrypsin deficiency
Recent hepatotoxic drug exposure
Cirrhosis with complications of portal hypertension including esophageal varices (> grade 1 by endoscopy), ascites, or hepatic encephalopathy, or bilirubin >2.0 mg/dl
Patients with advanced fibrosis (defined herein as decompensated cirrhosis, FIB4 > 2.5, platelet count <150 x 103/uL, clinical or radiographic evidence of cirrhosis)
Extrahepatic manifestations of liver disease or HIV co-infection
Use of fibric acid, Fenofibrate or cholestyramine
Active substance abuse including, but not limited to alcohol or i.v./inhaled drugs
Use of chemotherapy or systemic steroid therapy within 30 days prior to enrollment
Pregnancy, females who are breast feeding, or females of child bearing potential who are not using adequate birth control measures
History of a medical condition that could interfere with participation or completion of the protocol
Organ transplant recipient
History of hypersensitivity to ezetimibe
Intervention: Ezetimibe
Trial phase: Phase 2
ATC code: C10AX09 | C10BA02 | C10BA05 | C10BA06 | C10BA10 | C10BA11 | C10BA12
SMILES: [H][C@]1(CC[C@H](O)c2ccc(F)cc2)C(=O)N(c2ccc(F)cc2)[C@]1([H])c1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: 40mg/day ezetimibe

40mg ezetimibe: Participants assigned to this intervention will receive 40mg per day of ezetimibe for 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Males/females 18 - 70 yrs of age
Serum HCV RNA >2,000 IU/ml
Hepatitis C genotype 1
Other causes of chronic liver disease excluded by appropriate clinical, laboratory, or histologic evaluation

The following hematological criteria must be met:

Hemoglobin > 12 g/dl
Absolute neutrophil count (ANC) > 1.0x109 /L
Platelets 150 x 108 /L (i.e normal)
Serum creatinine <1.5 times the upper limit of normal (ULN) at screening.
Fasting blood sugar normal for non-diabetics or hemoglobin A1C < 8.5% with diabetes
Women of childbearing potential must have a negative pregnancy test prior to receiving treatment. Sexually active women must take adequate precautions to prevent pregnancy during the study. Pregnancy tests will be done at the final clinic visits and every 4 weeks
Patient provides written informed consent

Exclusion Criteria:

Evidence of liver disease other than HCV:

Antinuclear antibodies (ANA) >1:160
Active alcoholic liver disease.
Hepatitis B surface antigen positive
Hemochromatosis
Wilson disease
Alpha-1-antitrypsin deficiency
Recent hepatotoxic drug exposure
Cirrhosis with complications of portal hypertension including esophageal varices (> grade 1 by endoscopy), ascites, or hepatic encephalopathy, or bilirubin >2.0 mg/dl
Patients with advanced fibrosis (defined herein as decompensated cirrhosis, FIB4 > 2.5, platelet count <150 x 103/uL, clinical or radiographic evidence of cirrhosis)
Extrahepatic manifestations of liver disease or HIV co-infection
Use of fibric acid, Fenofibrate or cholestyramine
Active substance abuse including, but not limited to alcohol or i.v./inhaled drugs
Use of chemotherapy or systemic steroid therapy within 30 days prior to enrollment
Pregnancy, females who are breast feeding, or females of child bearing potential who are not using adequate birth control measures
History of a medical condition that could interfere with participation or completion of the protocol
Organ transplant recipient
History of hypersensitivity to ezetimibe
Intervention: 2-(6-Hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid
Trial phase: Not Applicable
SMILES: O=C(O)c1ccccc1-c1c2ccc(=O)cc-2oc2cc(O)ccc12
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 30
Group description: Once hysterectomy completed, a 10 % solution of sodium fluorescein at a 0,25 ml dose (25 mg) is injected before performing diagnostic cystoscopy for all patient.

Name: Fluorescite Injection 10%, contains sodium fluorescein (equivalent to fluorescein 10% w/v) Dosage : 25 mg Frequency: only once

sodium fluorescein injection 10%
Eligibility criteria:
Inclusion Criteria:

total laparoscopic hysterectomy

Exclusion Criteria:

breastfeeding
renal insufficiency
Medication: Probenecid, digoxin, quinidine, beta-blocker
hypersensitivity or intolerance to sodium fluorescein
Intervention: Isovaleric Acid
Trial phase: Phase 2
SMILES: CC(C)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Participants received Ivacaftor 150 mg orally every 12 hours for 28 days.
Eligibility criteria:
Inclusion Criteria:

18 years of age or older
Has a confirmed diagnosis of CF with at least one allele of the following CFTR gating mutations: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, and S549R.
Has been stable on Kalydeco therapy for at least 3 months prior to screening
Has FEV1 ≥ 60% of predicted normal for age, sex, and height at screening and baseline (Day 1) assessments
Weighs at least 40 kg at screening
Patients of either gender and women of childbearing potential must be willing to use a medically highly effective form of birth control during the treatment period and 30 days after the last dose of study treatment.

Exclusion Criteria:

Acute upper respiratory infection or lower respiratory infection, pulmonary exacerbation, or changes in therapy within 4 weeks of study treatment
Uncontrolled type 2 diabetes, or uncontrolled CF-related diabetes
History of hepatitis C or chronic active hepatitis B infection
History of pulmonary tuberculosis, non-tuberculosis mycobacterial infections or allergic bronchopulmonary aspergillosis (ABPA) treated during screening or within 2 years prior to screening
Colonization with B. cenocepacia, B. dolosa, B. multivorans, and/or M. abcessus within 2 years prior to Screening
Abnormal liver function
History of abnormal renal function
History of prolonged QTcF > 450 msec for males or QTcF > 470 msec for females
History of solid organ or hematological transplantation
Using any inhibitor or inducer of cytochrome P450/3A during the study or within 30 days of screening
Women who are pregnant or lactating, or have plans to become pregnant during the study or within 1 month following the last dose
Intervention: Propranolol
Trial phase: Phase 4
ATC code: C07AA05 | C07BA05 | C07FX01
SMILES: CC(C)NCC(O)COc1cccc2ccccc12
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 92
Group description: This is the experimental group given the beta-blocker propanolol hydrochloride. All subjects in this group received a single dose of 40mg of propanolol in a single tablet.
Eligibility criteria:
Inclusionary Criteria:

Healthy volunteers
Age 18-25
Fluent in English

Exclusionary Criteria:

presence or history of chronic physical illness (especially disorders with an inflammatory component, such as rheumatoid arthritis, asthma, allergies, or issues that can affect the heart, including low-blood pressure or other heart conditions)
presence or history of psychiatric illness (depression, anxiety)
any current prescription medication use
currently pregnant or planning to become pregnant
engagement in a number of health--compromising behaviors that may affect levels of pro-inflammatory cytokines, including cigarette smoking, excessive caffeine intake and sleep disturbance (e.g., working night shifts)
body mass index (BMI) greater than 30, given that adiposity is known to relate to baseline levels of inflammation
anxiety about or previous history of problems with blood draws (e.g., fainting)
any reported heart conditions
history of fainting spells
low pulse, as measured at beginning of session I (below 60)
low blood pressure, as measured at beginning of session I (below 80)
Intervention: Lanabecestat
Trial phase: Phase 3
SMILES: CC#Cc1cncc(-c2ccc3c(c2)[C@@]2(N=C(C)C(N)=N2)[C@]2(CC[C@H](OC)CC2)C3)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 76
Group description: Participants who received placebo in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.
Eligibility criteria:
Inclusion Criteria:

Participants previously enrolled in AMARANTH (NCT02245737) who meet eligibility criteria for delayed-start I8D-MC-AZFD.

Exclusion Criteria:

Participants who participate in AMARANTH (NCT02245737) who develop new conditions precluding them from enrolling into I8D-MC-AZFD.
Intervention: Lanabecestat
Trial phase: Phase 3
SMILES: CC#Cc1cncc(-c2ccc3c(c2)[C@@]2(N=C(C)C(N)=N2)[C@]2(CC[C@H](OC)CC2)C3)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 74
Group description: Participants who received placebo in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.
Eligibility criteria:
Inclusion Criteria:

Participants previously enrolled in AMARANTH (NCT02245737) who meet eligibility criteria for delayed-start I8D-MC-AZFD.

Exclusion Criteria:

Participants who participate in AMARANTH (NCT02245737) who develop new conditions precluding them from enrolling into I8D-MC-AZFD.
Intervention: Lanabecestat
Trial phase: Phase 3
SMILES: CC#Cc1cncc(-c2ccc3c(c2)[C@@]2(N=C(C)C(N)=N2)[C@]2(CC[C@H](OC)CC2)C3)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 131
Group description: Participants who received Lanabecestat 50 mg in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.
Eligibility criteria:
Inclusion Criteria:

Participants previously enrolled in AMARANTH (NCT02245737) who meet eligibility criteria for delayed-start I8D-MC-AZFD.

Exclusion Criteria:

Participants who participate in AMARANTH (NCT02245737) who develop new conditions precluding them from enrolling into I8D-MC-AZFD.
Intervention: Bupivacaine
Trial phase: Phase 3
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 19
Group description: Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.

Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
Eligibility criteria:
Inclusion Criteria :

American Society of Anesthesiologists physical status (ASA) < III
Age 18-40 year
Body Weight <110 kg
Height between 160 and 175 cm
Gestational age>37 SA
Elective cesarean delivery
Singleton pregnancy
Non complicated pregnancy
Signed informed consent obtained prior to any study specific assessments and procedures

Exclusion Criteria:

Twin pregnancy
History of 2 cesarean section or more
Diabetes and gestational diabetes
Placenta praevia
Congenital foetal abnormality
Intrauterine growth retardation
Patient in labour
Membrane rupture
Known allergy to local anaesthetics
Standard contraindications to neuraxial block.
Disagreement of the patient
Neurological impairment
Gestational low blood pressure
Pre eclampsia and eclampsia
Intervention: Everolimus
Trial phase: Phase 4
ATC code: L01EG02 | L04AA18
SMILES: COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(OCCO)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Patients experiencing gastrointestinal adverse effects in the first year post transplant will be converted from mycophenolate to everolimus

Everolimus
Eligibility criteria:
Inclusion Criteria:

Kidney transplant recipients at Washington University/Barnes-Jewish Hospital
Experiencing GI toxicity from MPA as determined by the treating physician within 12 months post-renal transplant
On standard immunosuppression with tacrolimus and prednisone

Exclusion Criteria:

Dual organ or kidney after another solid organ transplant
Presence of a preexisting significant GI condition that does not have a presumed causal relationship with MPA
Evidence of any GI disorder induced by an infection, underlying medical condition, or concomitant medication other than MPA
Estimated glomerular filtration rate (eGFR) <40 ml/min at time of possible conversion
Proteinuria >1 gram/day at time of possible conversion

Profound bone marrow suppression at the time of possible conversion as defined as:

Hemoglobin <10 g/dL
White blood cell (WBC) < 3 K/cumm
Platelets <100 K/cumm
Wound healing issues at time of possible conversion (eg, wound dehiscence, wound infection, incisional hernia, lymphocele, seroma)
Elevated total cholesterol (>350 mg/dL) and/or triglycerides (>500 ng/dL) at time of possible conversion
Hypersensitivity to everolimus, sirolimus, or other rapamycin derivatives
Intervention: MYCOPHENOLATE MOFETIL
Trial phase: Phase 4
SMILES: COc1c(C)c2c(c(O)c1C/C=C(\C)CCC(=O)OCCN1CCOCC1)C(=O)OC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Patient will have baseline data collected while on MPA for comparison with EVR

Mycophenolic Acid
Eligibility criteria:
Inclusion Criteria:

Kidney transplant recipients at Washington University/Barnes-Jewish Hospital
Experiencing GI toxicity from MPA as determined by the treating physician within 12 months post-renal transplant
On standard immunosuppression with tacrolimus and prednisone

Exclusion Criteria:

Dual organ or kidney after another solid organ transplant
Presence of a preexisting significant GI condition that does not have a presumed causal relationship with MPA
Evidence of any GI disorder induced by an infection, underlying medical condition, or concomitant medication other than MPA
Estimated glomerular filtration rate (eGFR) <40 ml/min at time of possible conversion
Proteinuria >1 gram/day at time of possible conversion

Profound bone marrow suppression at the time of possible conversion as defined as:

Hemoglobin <10 g/dL
White blood cell (WBC) < 3 K/cumm
Platelets <100 K/cumm
Wound healing issues at time of possible conversion (eg, wound dehiscence, wound infection, incisional hernia, lymphocele, seroma)
Elevated total cholesterol (>350 mg/dL) and/or triglycerides (>500 ng/dL) at time of possible conversion
Hypersensitivity to everolimus, sirolimus, or other rapamycin derivatives
Intervention: Timbetasin acetate
Trial phase: Phase 3
SMILES: CC(=O)O.CCC(C)C(NC(=O)C(CCC(=O)O)NC(=O)C(C)NC(=O)C(CCSC)NC(=O)C(CC(=O)O)NC(=O)C1CCCN1C(=O)C(CCCCN)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(C)=O)C(=O)NC(CCC(=O)O)C(=O)NC(CCCCN)C(=O)NC(Cc1ccccc1)C(=O)NC(CC(=O)O)C(=O)NC(CCCCN)C(=O)NC(CO)C(=O)NC(CCCCN)C(=O)NC(CC(C)C)C(=O)NC(CCCCN)C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(C(=O)NC(CCC(N)=O)C(=O)NC(CCC(=O)O)C(=O)NC(CCCCN)C(=O)NC(CC(N)=O)C(=O)N1CCCC1C(=O)NC(CC(C)C)C(=O)N1CCCC1C(=O)NC(CO)C(=O)NC(CCCCN)C(=O)NC(CCC(=O)O)C(=O)NC(C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC(CCC(=O)O)C(=O)NC(CCCCN)C(=O)NC(CCC(N)=O)C(=O)NC(C)C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CO)C(=O)O)C(C)CC)C(C)O)C(C)O)C(C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 299
Group description: Active (0.1% RGN-259 ophthalmic solution)
Eligibility criteria:
Inclusion Criteria:

Be at least 18 years of age;
Provide written informed consent;
Have a subject reported history of dry eye for at least 6 months
Have a history of use or desire to use eye drops for dry eye symptoms within 6 months

Exclusion Criteria:

Have any clinically significant slit-lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
Have ab uncontrolled systemic disease:
Intervention: Evobrutinib
Trial phase: Phase 2
SMILES: C=CC(=O)N1CCC(CNc2ncnc(N)c2-c2ccc(Oc3ccccc3)cc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 118
Group description: Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.
Eligibility criteria:
Inclusion Criteria:

Eligible male and female participants, aged 18 to 75 years
Must have diagnosis of SLE with either the Systemic Lupus International Collaborating Clinics (SLICC) criteria for SLE, or at least four of the 11 American College of Rheumatology (ACR) classification criteria for SLE, of at least six months duration prior to Screening
SLEDAI-2K total score greater than or equal to (>=) 6 (including clinical SLEDAI greater than or equal to (>=) 4) at Screening Visit
And be positive for anti-double-stranded Deoxyribonucleic Acid (DNA) and/or anti-nuclear antibody (ANA greater than or equal to (>=) 1:80) and/or anti-Smith (anti-Sm) antibody at the time of Screening
Other protocol defined inclusion criteria could apply

Exclusion Criteria:

Participants are not eligible for this study if they have active, clinically significant interstitial lung disease or pulmonary arterial hypertension
Proteinuria (urine protein to creatinine ratio [UPCR] > 4 mg/mg)
Acutely worsened renal function
Central nervous system SLE
Or within two weeks prior to Screening or during Screening: use of oral corticosteroids greater than (>) 30 mg daily prednisone equivalent
Use of injectable corticosteroids, or change in dose of corticosteroids.
Other protocol defined exclusion criteria could apply
Intervention: Evobrutinib
Trial phase: Phase 2
SMILES: C=CC(=O)N1CCC(CNc2ncnc(N)c2-c2ccc(Oc3ccccc3)cc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 117
Group description: Participants received 75 mg of M2951 orally QD for 52 weeks.
Eligibility criteria:
Inclusion Criteria:

Eligible male and female participants, aged 18 to 75 years
Must have diagnosis of SLE with either the Systemic Lupus International Collaborating Clinics (SLICC) criteria for SLE, or at least four of the 11 American College of Rheumatology (ACR) classification criteria for SLE, of at least six months duration prior to Screening
SLEDAI-2K total score greater than or equal to (>=) 6 (including clinical SLEDAI greater than or equal to (>=) 4) at Screening Visit
And be positive for anti-double-stranded Deoxyribonucleic Acid (DNA) and/or anti-nuclear antibody (ANA greater than or equal to (>=) 1:80) and/or anti-Smith (anti-Sm) antibody at the time of Screening
Other protocol defined inclusion criteria could apply

Exclusion Criteria:

Participants are not eligible for this study if they have active, clinically significant interstitial lung disease or pulmonary arterial hypertension
Proteinuria (urine protein to creatinine ratio [UPCR] > 4 mg/mg)
Acutely worsened renal function
Central nervous system SLE
Or within two weeks prior to Screening or during Screening: use of oral corticosteroids greater than (>) 30 mg daily prednisone equivalent
Use of injectable corticosteroids, or change in dose of corticosteroids.
Other protocol defined exclusion criteria could apply
Intervention: Evobrutinib
Trial phase: Phase 2
SMILES: C=CC(=O)N1CCC(CNc2ncnc(N)c2-c2ccc(Oc3ccccc3)cc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 117
Group description: Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.
Eligibility criteria:
Inclusion Criteria:

Eligible male and female participants, aged 18 to 75 years
Must have diagnosis of SLE with either the Systemic Lupus International Collaborating Clinics (SLICC) criteria for SLE, or at least four of the 11 American College of Rheumatology (ACR) classification criteria for SLE, of at least six months duration prior to Screening
SLEDAI-2K total score greater than or equal to (>=) 6 (including clinical SLEDAI greater than or equal to (>=) 4) at Screening Visit
And be positive for anti-double-stranded Deoxyribonucleic Acid (DNA) and/or anti-nuclear antibody (ANA greater than or equal to (>=) 1:80) and/or anti-Smith (anti-Sm) antibody at the time of Screening
Other protocol defined inclusion criteria could apply

Exclusion Criteria:

Participants are not eligible for this study if they have active, clinically significant interstitial lung disease or pulmonary arterial hypertension
Proteinuria (urine protein to creatinine ratio [UPCR] > 4 mg/mg)
Acutely worsened renal function
Central nervous system SLE
Or within two weeks prior to Screening or during Screening: use of oral corticosteroids greater than (>) 30 mg daily prednisone equivalent
Use of injectable corticosteroids, or change in dose of corticosteroids.
Other protocol defined exclusion criteria could apply
Intervention: Evobrutinib
Trial phase: Phase 2
SMILES: C=CC(=O)N1CCC(CNc2ncnc(N)c2-c2ccc(Oc3ccccc3)cc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 69
Group description: Participants who received 25 mg of M2951 orally QD in DBPC period were switched to receive 50 mg M2951 orally BID in LTE period for 104 weeks.
Eligibility criteria:
Inclusion Criteria:

Eligible male and female participants, aged 18 to 75 years
Must have diagnosis of SLE with either the Systemic Lupus International Collaborating Clinics (SLICC) criteria for SLE, or at least four of the 11 American College of Rheumatology (ACR) classification criteria for SLE, of at least six months duration prior to Screening
SLEDAI-2K total score greater than or equal to (>=) 6 (including clinical SLEDAI greater than or equal to (>=) 4) at Screening Visit
And be positive for anti-double-stranded Deoxyribonucleic Acid (DNA) and/or anti-nuclear antibody (ANA greater than or equal to (>=) 1:80) and/or anti-Smith (anti-Sm) antibody at the time of Screening
Other protocol defined inclusion criteria could apply

Exclusion Criteria:

Participants are not eligible for this study if they have active, clinically significant interstitial lung disease or pulmonary arterial hypertension
Proteinuria (urine protein to creatinine ratio [UPCR] > 4 mg/mg)
Acutely worsened renal function
Central nervous system SLE
Or within two weeks prior to Screening or during Screening: use of oral corticosteroids greater than (>) 30 mg daily prednisone equivalent
Use of injectable corticosteroids, or change in dose of corticosteroids.
Other protocol defined exclusion criteria could apply