A study of Baricitinib in patients with Lupus

• Register: EUCTR
• Last refreshed on: 16 May 2022
• Main ID: EUCTR2017-005028-11-PL
• Date of registration: 23/04/2019
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A study of Baricitinib in patients with Lupus
• Scientific title: A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE)
• Date of first enrolment: 05/07/2019
• Target sample size: 1100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-005028-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Croatia, Czech Republic, France, Germany, Greece, Hungary, India, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Philippines, Poland, Romania, Russian Federation, Serbia, South Africa, Spain, Switzerland, Taiwan, United Kingdom, United States

Contacts

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly

Key inclusion & exclusion criteria

Inclusion criteria:
Patients are eligible to be included in the study only if they meet all of
the following criteria at
screening:
Type of Patient and Disease Characteristics
[1] Have completed the final treatment study visit of an originating
study, such as Study JAHZ or Study JAIA. Patient Characteristics
[2] Male or nonpregnant, nonbreastfeeding female patient
a. Patients of child-bearing potential who are abstinent (if this iscomplete abstinence, as their preferred and usual lifestyle) or in a samesex
relationship
(as part of their preferred and usual lifestyle) must agree to either
remain abstinent or stay in a same-sex relationship without sexual
relationships with the opposite sex.
b. Total abstinence is defined as refraining from intercourse during the
entirety of the study and for at least 1 week following the last dose of
investigational product. Periodic abstinence, such as calendar,
ovulation, symptothermal, post-ovulation methods, and withdrawal, are
not acceptable methods of contraception.
c. Otherwise, patients of childbearing potential together with their
partners must agree to use 2 effective methods of contraception, where
at least 1 form is highly effective, for the entirety of the study and for at
least 1 week following the last dose of investigational product.
d. The following contraception methods are considered acceptable (the
patient should choose 2, and 1 must be highly effective [defined as less
than 1%
failure rate per year when used consistently and correctly]):
? Highly effective birth control methods:
? Combined (estrogen and progestogen containing) hormonal
contraception associated with inhibition of ovulation: oral, intravaginal,
or transdermal
? Progestogen-only containing hormonal contraception associated with
inhibition of ovulation: oral, intravaginal, or transdermal
? Intrauterine device (IUD)/intrauterine hormone-releasing system
(IUS)
? Vasectomized male (with appropriate post-vasectomy documentation
of the absence of sperm in the ejaculate).
? Effective birth control methods:
? Male or female condom with spermicide. It should be noted that the
use of male and female condoms as a double barrier method is not
considered acceptable due to the high failure rate when these methods
are combined.
? Diaphragm with spermicide
? Cervical sponge
? Cervical cap with spermicide
Note: When local guidelines concerning highly effective or effective
methods of birth control differ from the above, the local guidelines must
be followed.
Patients of non?child-bearing potential are not required to use birth
control and they are defined as:
? Women who are infertile due to surgical sterilization (hysterectomy,
bilateral oophorectomy, or tubal ligation)
? Post-menopausal – defined either as
? A woman at least 50 years of age with an intact uterus, not on
hormone therapy, who has had either
? Cessation of menses for at least 1 year
? At least 6 months of spontaneous amenorrhea with folliclestimulating
hormone >40 mIU/mL
? Women aged 55 years or older who are not on hormone therapy, and
who have had at least 6 months of spontaneous amenorrhea
? Women aged 55 years or older who have a diagnosis of menopause
Informed Consent
[3] Must read and understand the informed consent approved by Eli Lilly
and
Company (Lilly), or its designee, and the institutional review board
(IRB)/ethics
review board (ERB) governing the site, and provide written informed
consent.
Are the trial subjects
Exclusion criteria:
[1] Have significant uncontrolled cerebro-cardiovascular (for example,
myocardial infarction, unstable angina, unstable arterial hypertension,
severe heart failure, or cerebrovascular accident), respiratory, hepatic,
renal, gastrointestinal, endocrine, hematologic, neuropsychiatric
disorders, or abnormal laboratory values that, in the opinion of the
investigator, pose an unacceptable risk to the patient if investigational
product continues to be administered.
[2] Have a known hypersensitivity to baricitinib or any component of
this investigational product.
[3] Had investigational product permanently discontinued at any time
during a previous baricitinib study.
[3] Had temporary investigational product interruption at the final study
visit of a previous baricitinib study and, in the opinion of the
investigator, this poses an unacceptable risk for the patient's
participation in the study.
[4] Have any other condition that, in the opinion of the investigator,
renders the patient unable to understand the nature, scope, and possible
consequences of the study or precludes the patient from following and
completing the protocol.
[5] Are currently enrolled in any other clinical study involving an
investigational product or any other type of medical research, judged not
to be scientifically or medically compatible with this study.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1 Level: LLT Classification code 10025139 Term: Lupus erythematosus systemic System Organ Class: 100000004859

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Baricitinib
Current Sponsor code: LY3009104
Other descriptive name: BARICITINIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Baricitinib
Current Sponsor code: LY3009104
Other descriptive name: BARICITINIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: To evaluate the long-term safety and tolerability of baricitinib in patients
with SLE.

Primary end point(s): ? Proportion of patients with treatment-emergent adverse events
(TEAEs), adverse events of special interest (AESIs), and serious adverse
events (SAEs).
? Proportion of patients with temporary investigational product
interruptions and permanent discontinuations.

Timepoint(s) of evaluation of this end point: The change will be evaluated from the baseline time point to the study
week 156 time point

Secondary Objective: - To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD and
background standard-of-care therapy on SLE disease activity
- To evaluate the long-term corticosteroid sparing effect of baricitinib 4-
mg or 2-mg QD
- To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD on SLE
flares
- To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD on
mucocutaneous manifestations of SLE
- To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD on
musculoskeletal manifestations of SLE
- To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD on
individual organ system disease activity.
- To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD on
damage.
- To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD on
patient-reported outcomes (PROs)

Secondary Outcome(s)

Secondary end point(s): Proportion of patients achieving SRI-4 response through Week 156,
defined as:
- Reduction of =4 points from baseline in SLEDAI-2K score; and
- No new British Isles Lupus Assessment Group (BILAG) A or no more
than 1 new BILAG B disease activity score; and
- No worsening (defined as an increase of =0.3 points [10 mm] from
baseline) in the Physician's
Global Assessment of Disease Activity.
Proportion of patients achieving an SRI-5, -6, -7, or -8 response through
Week 156.
Proportion of patients achieving an LLDAS response through Week 156.
Change from baseline in mean total SLEDAI-2Kscores through Week 156.
Change from baseline in Physician's Global Disease Activity score
through Week 156.
Proportion of patients receiving >7.5 mg prednisone (or equivalent) at
baseline able to decrease dose by =25% to a prednisone equivalent dose
of =7.5 mg/day maintained for at least 12 weeks through Week 156.
Change from baseline in prednisone dose through Week 156.
Proportion of patients taking corticosteroids at baseline able to
discontinue use through Week 156.
Annualized mild/moderate flare rate
Annualized severe flare rate
Annualized flare rate (any severity).
Proportion of patients with CLASI total activity score = 10 at baseline
with =50% reduction in CLASI total activity score through Week 156.
Change from baseline in tender joint count through Week 156.
Change from baseline in swollen joint count through Week 156.
Proportion of patients with improvement in each SLEDAI-2K organ
system versus baseline through Week 156.
Proportion of patients with worsening in each SLEDAI-2K organ system
versus baseline through Week 156.
Change from baseline in SLICC/ACR damage index total score through
Week 156.
Change from baseline in Worst Pain NRS through Week 156.
Change from baseline in Worst Joint Pain NRS through Week 156.
Change from baseline in Worst Fatigue NRS through Week 156.
Change from baseline in Patient Global Impression of Severity through
Week 156.
Change from baseline in mental component score (MCS), physical
component score (PCS), and domain scores in the Short-Form 36-item
health
survey version 2 (SF- 36v2) acute through Week 156.
Change from baseline in FACIT-F total score through Week 156.
Change from baseline in the EQ-5D-5L through Week 156.
Change from baseline in the WPAI-Lupus through Week 156.

Timepoint(s) of evaluation of this end point: The change will be evaluated from the baseline time point to the study
week 156 time point

Secondary ID(s)

I4V-MC-JAIM

2017-005028-11-GB

Source(s) of Monetary Support

Eli Lilly and Company

Ethics review

Status: Approved
Approval date: 02/07/2019
Contact: