A Study of LY3375880 in Adults With Moderate-to-Severe At... | NCT03831191 | Trialant
NCT03831191
Sponsor
Eli Lilly and Company
Status
Terminated
Last Update Posted
Apr 20, 2021Actual
Enrollment
136Actual
Phase
Phase 2
Conditions
Atopic Dermatitis
Interventions
LY3375880
Placebo
Countries
United States
Argentina
Austria
Canada
Czechia
France
Germany
Hungary
Italy
Japan
Mexico
Puerto Rico
Spain
Protocol Section
Identification Module
NCT ID
NCT03831191
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
17104
Secondary IDs
ID
Type
Description
Link
I9N-MC-FCAB
Other Identifier
Eli Lilly and Company
2018-002401-56
EudraCT Number
Brief Title
A Study of LY3375880 in Adults With Moderate-to-Severe Atopic Dermatitis
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of LY3375880 in Adult Subjects With Moderate-to-Severe Atopic Dermatitis: The ADmIRe Study
Acronym
ADmIRe
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Jun 2020
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The study was terminated for lack of efficacy after an interim analysis was performed
Expanded Access Info
No
Start Date
Feb 12, 2019Actual
Primary Completion Date
Feb 27, 2020Actual
Completion Date
Feb 27, 2020Actual
First Submitted Date
Feb 4, 2019
First Submission Date that Met QC Criteria
Feb 4, 2019
First Posted Date
Feb 5, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Feb 12, 2021
Results First Submitted that Met QC Criteria
Mar 24, 2021
Results First Posted Date
Apr 20, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 24, 2021
Last Update Posted Date
Apr 20, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The reason for this study is to see if the study drug LY3375880 is safe and effective in adults with moderate-to-severe atopic dermatitis (AD).
Detailed Description
Not provided
Conditions Module
Conditions
Atopic Dermatitis
Keywords
eczema
atopic eczema
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
136Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
50 mg LY3375880
Experimental
Induction Period:
Participants received 50 mg LY3375880 administered SC Q4W.
Drug: LY3375880
150 mg LY3375880
Experimental
Induction Period:
Participants received 150 mg LY3375880 administered SC Q4W.
Drug: LY3375880
600 mg LY3375880
Experimental
Induction Period:
Participants received 600 mg LY3375880 administered SC Q4W.
Drug: LY3375880
Placebo
Placebo Comparator
Induction Period:
Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY3375880
Drug
Administered SC
150 mg LY3375880
50 mg LY3375880
600 mg LY3375880
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving Validated Investigator's Global Assessment for AD (vIGA-AD) of 0 or 1 With a ≥2 Point Improvement
vIGA-AD measures participants' overall severity of their atopic dermatitis (AD), based on a static, numeric 5 point scale from 0 (clear) to 4 (severe). Higher scores indicate greater severity.The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Non-responder imputation (NRI) method was used to impute missing data.
Week 16
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI-75)
EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs - by scoring the extent of disease (percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%) and the severity of 4 clinical signs (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed. Each body site will have a score that ranges from 0 to 72, and the final EASI score will be obtained by weight-averaging these 4 scores. Hence, the final EASI score will range from 0 to 72 (severe) for each time point. A higher score represented greater disease severity.The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. Non-responder imputation (NRI) method was used to impute missing data.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants must have diagnosis of AD >= 12 months according to the American Academy of Dermatology criteria.
Participants must have moderate to severe AD at screening and randomization.
Participants must have inadequate response to topical medications within 6 months of screening (or history of intolerance).
Exclusion Criteria:
Participants must not have concurrent treatment with topical or systemic treatments for AD.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Tien Q. Nguyen, MD inc. DBA First OC Dermatology
Fountain Valley
California
92708
United States
References Module
Citations
Not provided
See Also Links
Label
URL
A Study of LY3375880 in Adults With Moderate-to-Severe Atopic Dermatitis
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Responders are participants who achieved a 50% reduction in the Eczema Area and Severity Index score [EASI-50] response, regardless of whether rescue therapy had been initiated during induction period. Participants did not receive 300 mg because the trial was stopped early.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Induction Period:
Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
FG001
50 mg LY3375880
Induction Period:
Participants received 50 milligrams (mg) LY3375880 administered SC Q4W.
Periods
Title
Milestones
Reasons Not Completed
Induction Period (16 Weeks)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jul 25, 2019
Nov 20, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Placebo
Drug
Administered SC
Placebo
Week 16
Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD-75)
The SCORAD index uses the rule of nines to assess disease extent (head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; and genitals 1%). It evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss in the last 72 hours on visual analogue scales (VAS) of 0 to 10 where 0 is no itch or sleep loss and 10 is worst imaginable itch or sleep loss. These 3 aspects: extent of disease, disease severity, and subjective symptoms combine to give a score between 0(no disease) and 103 (severe disease). Higher scores indicate greater severity.Non-responder imputation (NRI) method was used to impute missing data.
Week 16
Percentage of Participants Achieving vIGA-AD of 0
vIGA-AD measures participants overall severity of their atopic dermatitis (AD), based on a static, numeric 5 point scale from 0 (clear) to 4 (severe). Higher scores indicate greater severity. The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Non-responder imputation (NRI) method was used to impute missing data.
Week 16
Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score
EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis-disease extent and clinical signs-by scoring the extent of disease(percentage of skin affected: 0= 0%;1 =1-9%; 2 =10-29%;3 = 30-49%;4 = 50-69%;5 = 70-89%;6 = 90-100%) and the severity of 4 clinical signs (erythema,edema/papulation,excoriation,and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 =mild; 2 = moderate; 3=severe) at 4 body sites(head and neck,trunk,upper limbs,and lower limbs).Half scores are allowed.Each body site will have a score that ranges from 0 to 72,and the final EASI score will be obtained by weight-averaging these 4 scores.Hence,the final EASI score will range from 0 to 72(severe) for each time point.Higher scores indicate greater severity.Least Squares Mean(LS Means) were calculated using mixed model repeated measures(MMRM) with treatment,region, baseline disease severity,visit,treatment-by-visit-interaction,baseline and baseline-by-visit-interaction as fixed effects.
Baseline, Week 16
Mean Change From Baseline in SCORAD
The SCORAD index uses the rule of nines to assess disease extent (head and neck 9%;upper limbs 9% each;lower limbs 18% each;anterior trunk 18%;back 18%;and genitals 1%).It evaluates 6 clinical characteristics to determine disease severity: (1)erythema,(2)edema/papulation, (3)oozing/crusts,(4) excoriation,(5) lichenification, and (6) dryness on a scale of 0 to 3(0=absence,1=mild,2=moderate,3=severe).The SCORAD index also assesses subjective symptoms of pruritus and sleep loss in the last 72 hours on visual analogue scales(VAS) of 0 to 10 where 0 is no itch or sleep loss and 10 is worst imaginable itch or sleep loss.These 3 aspects: extent of disease,disease severity,and subjective symptoms combine to give a score between 0(no disease) and 103(severe disease).Higher scores indicate greater severity. LS Means were calculated using a MMRM model with treatment,region,baseline disease severity,visit, treatment-by-visit-interaction,baseline and baseline-by-visit-interaction as fixed effects.
Baseline, Week 16
Percentage of Participants Achieving vIGA-AD of 0 or 1 With a >=2-point Improvement at Week 52
vIGA-AD measures participants overall severity of their atopic dermatitis (AD), based on a static, numeric 5 point scale from 0 (clear) to 4 (severe). Higher scores indicate greater severity. The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Non-responder imputation (NRI) method was used to impute missing data.
Week 52
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve at a Steady State (AUCτ,ss) of LY3375880
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve at a steady state (AUCτ,ss) of LY3375880. The PK model was fit using all quantifiable concentrations that were collected in the study (i.e., from the induction and maintenance periods).
Induction Period: Pre-dose, Day 0, Day 7, Day 14, Day 28, Day 56, Day 112 Post-dose; Maintenance Period:Predose, Day 168; Day 252, Day 364 Post-dose
Dermatology Research Associates
Los Angeles
California
90045
United States
Quest Dermatology Research
Northridge
California
91324
United States
Integrative Skin Science and Research
Sacramento
California
95815
United States
Arlington Dermatology
Rolling Meadows
Illinois
60008
United States
The South Bend Clinic
South Bend
Indiana
46617
United States
Dermatology and Skin Cancer Specialists
Rockville
Maryland
20850
United States
ActivMed Practices & Research, Inc
Portsmouth
New Hampshire
03801
United States
Piedmont Plastic Surgery and Dermatology
Charlotte
North Carolina
28277
United States
PMG Research of Wilmington, LLC
Wilmington
North Carolina
28411
United States
Hightower Clinical Trial Services
Norman
Oklahoma
73072
United States
Oregon Dermatology and Research Center
Portland
Oregon
97210
United States
Clinical Partners LLC
Johnston
Rhode Island
02919
United States
Center for Clinical Studies
Houston
Texas
77004
United States
DOM- Centro de Reumatologia
CABA
Buenos Aires
1111
Argentina
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires
C1027AAP
Argentina
Buenos Aires Skin
Ciudad Autonoma Buenos Aires
C1055AA0
Argentina
Instituto de Neumonología y Dermatología
Ciudad Autonoma Buenos Aires
C1425BEA
Argentina
Psoriahue Medicina Interdisciplinaria
Ciudad Autonoma Buenos Aires
C1425DKG
Argentina
Parra Dermatología
Mendoza
5500
Argentina
Centro Medico Privado de Reumatologia
San Miguel de Tucumán
T4000AXL
Argentina
Universitätsklinikum Graz
Graz
Styria
8036
Austria
LKH Feldkirch
Feldkirch
Vorarlberg
6807
Austria
Sozialmed. Zentrum Ost - Donauspital
Vienna
1220
Austria
The Guenther Dermatology Research Centre
London
Ontario
N6A 3H7
Canada
Clintrial, s.r.o.
Prague
Hl. M. Praha
100 00
Czechia
Sanatorium Profesora Arenbergera
Prague
110 00
Czechia
CHU de Nice Hopital de L'Archet
Nice
06202
France
Dermatologikum Hamburg
Hamburg
20354
Germany
TFS Trial Form Support GmbH
Hamburg
20537
Germany
Oroshaza Varosi Onkormanyzat Korhaza
Orosháza
Bekes County
5900-H
Hungary
Allergo-Derm Bakos Kft
Szolnok
Jász-Nagykun-Szolnok
5000
Hungary
UNO Medical Trials Kft.
Budapest
1135
Hungary
MedMare Bt
Veszprém
8200
Hungary
Policlinico di Tor Vergata
Rome
Lazio
00133
Italy
Istituto Clinico Humanitas
Rozzano
Milano
20089
Italy
Polic.Umberto I -Univ. La Sapienza
Roma
00161
Italy
Yasumoto Dermatology Clinic
Chikushino-shi
Fukuoka
818 0083
Japan
Takagi Dermatological Clinic
Obihiro
Hokkaido
080-0013
Japan
Kobe University Hospital
Kobe
Hyōgo
650-0017
Japan
Meiwa Hospital
Nishinomiya
Hyōgo
663-8186
Japan
Kyoto Prefectural University of Medicine
Kyoto
Kyoto
602-8566
Japan
Oita University Hospital
Yufu-shi
Oita Prefecture
8795593
Japan
Kume Clinic
Nishi-ku Sakai-shi
Osaka
593-8324
Japan
Dokkyo Medical University Saitama Medical Center
Koshigaya
Saitama
343 8555
Japan
Sumire Dermatology Clinic
Edogawa-ku
Tokyo
133-0057
Japan
Matsuda Tomoko Dematological Clinic
Fukuoka
819 0167
Japan
Grupo Medico Camino S.C.
Mexico City
Mexico City
03310
Mexico
Derma Norte del Bajío, S.C.
Aguascalientes
Mexico
Office of Dr. Samuel Sanchez PSC
Caguas
PR
00727
Puerto Rico
Office of Dr. Alma M. Cruz
Carolina
PR
00985
Puerto Rico
Ponce School of Medicine CAIMED Center
Ponce
PR
00716
Puerto Rico
GCM Medical Group PSC
San Juan
PR
00917
Puerto Rico
Clinical Research Puerto Rico, Inc.
San Juan
00909
Puerto Rico
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat
Barcelona
08907
Spain
Clinica Universitaria De Navarra
Pamplona
Navarre
31008
Spain
Clinica Universidad De Navarra
Madrid
28027
Spain
Hospital Universitario La Paz
Madrid
28046
Spain
FG002
150 mg LY3375880
Induction Period:
Participants received 150 mg LY3375880 administered SC Q4W.
FG003
600 mg LY3375880
Induction Period:
Participants received 600 mg LY3375880 administered SC Q4W.
FG004
Placebo Responder to Placebo/300 mg LY3375880
Maintenance Period:
Participants received placebo administered SC Q4W until loss of response then 300 mg LY3375880 SC Q4W .
Participants had received placebo SC Q4W during the induction period.
FG005
Placebo Non-Responder to 300 mg LY3375880
Maintenance Period:
Participants received 300 mg LY3375880 administered SC Q4W.
Participants had received placebo SC Q4W during the induction period.
FG006
50 mg Responder to Placebo/50 mg LY3375880
Maintenance Period:
Participants received placebo administered SC Q4W until loss of response then 50 mg LY3375880 SC Q4W.
Participants had received 50 mg LY3375880 SC Q4W during the induction period.
FG007
50 mg LY3375880 Responder to 50 mg LY3375880
Maintenance Period:
Participants received 50 mg LY3375880 administered SC Q4W.
Participants had received 50 mg LY3375880 SC Q4W during the induction period.
FG008
50 mg LY3375880 Non-Responder to 150 mg LY3375880
Maintenance Period:
Participants received 150 mg LY3375880 administered SC Q4W.
Participants had received 50 mg LY3375880 SC Q4W during the induction period.
FG009
150 mg Responder to Placebo/150 mg LY3375880
Maintenance Period:
Participants received placebo administered SC Q4W until loss of response then 150 mg LY3375880 SC Q4W.
Participants had received 150 mg LY3375880 SC Q4W during the induction period.
FG010
150 mg LY3375880 Responder to 150 mg LY3375880
Maintenance Period:
Participants received 150 mg LY3375880 administered SC Q4W.
Participants had received 150 mg LY3375880 SC Q4W during the induction period.
FG011
150 mg LY3375880 Non-Responder to 300 mg LY3375880
Maintenance Period:
Participants received 300 mg LY3375880 administered SC Q4W.
Participants had received 150 mg LY3375880 SC Q4W during the induction period.
FG012
600 mg Responder to Placebo/600 mg LY3375880
Maintenance Period:
Participants received placebo administered SC Q4W until loss of response then 600 mg LY3375880 SC Q4W.
Participants had received 600 mg LY3375880 SC Q4W during the induction period.
FG013
600 mg LY3375880 Responder to 600 mg LY3375880
Maintenance Period:
Participants received 600 mg LY3375880 administered SC Q4W.
Participants had received 600 mg LY3375880 SC Q4W during the induction period.
FG014
600 mg LY3375880 Non-Responder to 600 mg LY3375880
Maintenance Period:
Participants received 600 mg LY3375880 administered SC Q4W.
Participants had received 600 mg LY3375880 SC Q4W during the induction period.
FG00033 subjects
FG00135 subjects
FG00234 subjects
FG00334 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Received at Least One Dose of Study Drug
FG00033 subjects
FG00135 subjects
FG00234 subjects
FG00333 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
COMPLETED
FG00010 subjects
FG00114 subjects
FG00213 subjects
FG00311 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
NOT COMPLETED
FG00023 subjects
FG00121 subjects
FG00221 subjects
FG00323 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0011 subjects
FG0023 subjects
FG0034 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Lack of Efficacy
FG0002 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG004
Pregnancy
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Withdrawal by Subject
FG0007 subjects
FG0012 subjects
FG0021 subjects
FG0033 subjects
FG004
Study Terminated by Sponsor
FG00012 subjects
FG00115 subjects
FG00216 subjects
FG00313 subjects
FG004
Sponsor Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Maintenance Period (36 Weeks)
Type
Comment
Milestone Data
STARTED
FG0000 subjectsParticipants were assigned to this arm during induction period.
FG0010 subjectsParticipants were assigned to this arm during induction period.
FG0020 subjectsParticipants were assigned to this arm during induction period.
FG0030 subjectsParticipants were assigned to this arm during induction period.
FG0044 subjectsParticipants were assigned to this arm during maintenance period.
FG0055 subjectsParticipants were assigned to this arm during maintenance period.
FG0062 subjectsParticipants were assigned to this arm during maintenance period.
FG0074 subjectsParticipants were assigned to this arm during maintenance period.
FG0088 subjectsParticipants were assigned to this arm during maintenance period.
FG0091 subjectsParticipants were assigned to this arm during maintenance period.
FG0104 subjectsParticipants were assigned to this arm during maintenance period.
FG0118 subjectsParticipants were assigned to this arm during maintenance period.
FG0121 subjectsParticipants were assigned to this arm during maintenance period.
FG0131 subjectsParticipants were assigned to this arm during maintenance period.
FG0149 subjectsParticipants were assigned to this arm during maintenance period.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Study Terminated by Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Post-Treatment Follow-Up Period(8 Weeks)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjectsNo participant entered the post follow-up period.
FG0120 subjects
FG0130 subjects
FG0140 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
All randomized participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Induction Period:
Participants received placebo administered SC Q4W.
BG001
50 mg LY3375880
Induction Period:
Participants received 50 mg LY3375880 administered SC Q4W.
BG002
150 mg LY3375880
Induction Period:
Participants received 150 mg LY3375880 administered SC Q4W.
BG003
600 mg LY3375880
Induction Period:
Participants received 600 mg LY3375880 administered SC Q4W.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00033
BG00135
BG00234
BG00334
BG004136
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00037.00± 14.98
BG00137.70± 16.00
BG00239.50± 13.94
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00011
BG00116
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0009
BG00111
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0001
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
Argentina
Title
Measurements
BG0005
BG0013
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants Achieving Validated Investigator's Global Assessment for AD (vIGA-AD) of 0 or 1 With a ≥2 Point Improvement
vIGA-AD measures participants' overall severity of their atopic dermatitis (AD), based on a static, numeric 5 point scale from 0 (clear) to 4 (severe). Higher scores indicate greater severity.The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Non-responder imputation (NRI) method was used to impute missing data.
Induction Period: All randomized participants who completed or discontinued the study prior to study termination by the sponsor.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 16
ID
Title
Description
OG000
Placebo
Induction Period:
Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
OG001
50 mg LY3375880
Induction Period:
Participants received 50 mg LY3375880 administered SC Q4W.
OG002
150 mg LY3375880
Induction Period:
Participants received 150 mg LY3375880 administered SC Q4W.
OG003
600 mg LY3375880
Induction Period:
Participants received 600 mg LY3375880 administered SC Q4W.
Units
Counts
Participants
OG00021
OG00120
OG00217
OG003
Title
Denominators
Categories
Title
Measurements
OG0009.5(2.7 to 28.9)
OG0015.0(0.9 to 23.6)
OG0025.9(1.0 to 27.0)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
0.638
Odds Ratio (OR)
0.55
2-Sided
95
0.04
6.81
Superiority
OG000
OG002
Regression, Logistic
0.773
Secondary
Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI-75)
EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs - by scoring the extent of disease (percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%) and the severity of 4 clinical signs (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed. Each body site will have a score that ranges from 0 to 72, and the final EASI score will be obtained by weight-averaging these 4 scores. Hence, the final EASI score will range from 0 to 72 (severe) for each time point. A higher score represented greater disease severity.The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. Non-responder imputation (NRI) method was used to impute missing data.
Induction Period: All randomized participants who completed or discontinued the study prior to study termination by the sponsor.
Posted
Number
95% Confidence Interval
Percentage of Participants
Week 16
ID
Title
Description
OG000
Placebo
Induction Period:
Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
OG001
50 mg LY3375880
Induction Period:
Participants received 50 mg LY3375880 administered SC Q4W.
Secondary
Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD-75)
The SCORAD index uses the rule of nines to assess disease extent (head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; and genitals 1%). It evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss in the last 72 hours on visual analogue scales (VAS) of 0 to 10 where 0 is no itch or sleep loss and 10 is worst imaginable itch or sleep loss. These 3 aspects: extent of disease, disease severity, and subjective symptoms combine to give a score between 0(no disease) and 103 (severe disease). Higher scores indicate greater severity.Non-responder imputation (NRI) method was used to impute missing data.
Induction Period: All randomized participants who completed or discontinued the study prior to study termination by the sponsor.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 16
ID
Title
Description
OG000
Placebo
Induction Period:
Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
OG001
50 mg LY3375880
Induction Period:
Participants received 50 mg LY3375880 administered SC Q4W.
Secondary
Percentage of Participants Achieving vIGA-AD of 0
vIGA-AD measures participants overall severity of their atopic dermatitis (AD), based on a static, numeric 5 point scale from 0 (clear) to 4 (severe). Higher scores indicate greater severity. The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Non-responder imputation (NRI) method was used to impute missing data.
Induction Period: All randomized participants who completed or discontinued the study prior to study termination by the sponsor.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 16
ID
Title
Description
OG000
Placebo
Induction Period:
Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
OG001
50 mg LY3375880
Induction Period:
Participants received 50 mg LY3375880 administered SC Q4W.
OG002
150 mg LY3375880
Induction Period:
Participants received 150 mg LY3375880 administered SC Q4W.
OG003
600 mg LY3375880
Secondary
Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score
EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis-disease extent and clinical signs-by scoring the extent of disease(percentage of skin affected: 0= 0%;1 =1-9%; 2 =10-29%;3 = 30-49%;4 = 50-69%;5 = 70-89%;6 = 90-100%) and the severity of 4 clinical signs (erythema,edema/papulation,excoriation,and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 =mild; 2 = moderate; 3=severe) at 4 body sites(head and neck,trunk,upper limbs,and lower limbs).Half scores are allowed.Each body site will have a score that ranges from 0 to 72,and the final EASI score will be obtained by weight-averaging these 4 scores.Hence,the final EASI score will range from 0 to 72(severe) for each time point.Higher scores indicate greater severity.Least Squares Mean(LS Means) were calculated using mixed model repeated measures(MMRM) with treatment,region, baseline disease severity,visit,treatment-by-visit-interaction,baseline and baseline-by-visit-interaction as fixed effects.
Induction Period: All randomized participants who had a baseline and at least one post-baseline EASI value.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Induction Period:
Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
OG001
50 mg LY3375880
Induction Period:
Participants received 50 mg LY3375880 administered SC Q4W.
Secondary
Mean Change From Baseline in SCORAD
The SCORAD index uses the rule of nines to assess disease extent (head and neck 9%;upper limbs 9% each;lower limbs 18% each;anterior trunk 18%;back 18%;and genitals 1%).It evaluates 6 clinical characteristics to determine disease severity: (1)erythema,(2)edema/papulation, (3)oozing/crusts,(4) excoriation,(5) lichenification, and (6) dryness on a scale of 0 to 3(0=absence,1=mild,2=moderate,3=severe).The SCORAD index also assesses subjective symptoms of pruritus and sleep loss in the last 72 hours on visual analogue scales(VAS) of 0 to 10 where 0 is no itch or sleep loss and 10 is worst imaginable itch or sleep loss.These 3 aspects: extent of disease,disease severity,and subjective symptoms combine to give a score between 0(no disease) and 103(severe disease).Higher scores indicate greater severity. LS Means were calculated using a MMRM model with treatment,region,baseline disease severity,visit, treatment-by-visit-interaction,baseline and baseline-by-visit-interaction as fixed effects.
Induction Period: All randomized participants who had a baseline and at least one post-baseline SCORAD value.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Induction Period:
Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
OG001
50 mg LY3375880
Induction Period:
Participants received 50 mg LY3375880 administered SC Q4W.
Secondary
Percentage of Participants Achieving vIGA-AD of 0 or 1 With a >=2-point Improvement at Week 52
vIGA-AD measures participants overall severity of their atopic dermatitis (AD), based on a static, numeric 5 point scale from 0 (clear) to 4 (severe). Higher scores indicate greater severity. The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Non-responder imputation (NRI) method was used to impute missing data.
Maintenance Period: All randomized participants who had a >=2-point improvement at Week 52.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 52
ID
Title
Description
OG000
Placebo
Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
OG001
50 mg LY3375880
Participants received 50 mg LY3375880 administered SC Q4W.
OG002
150 mg LY3375880
Participants received 150 mg LY3375880 administered SC Q4W.
OG003
300 mg LY3375880
Secondary
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve at a Steady State (AUCτ,ss) of LY3375880
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve at a steady state (AUCτ,ss) of LY3375880. The PK model was fit using all quantifiable concentrations that were collected in the study (i.e., from the induction and maintenance periods).
All randomized participants who received LY3375880 in induction and maintenance period who had evaluable PK data. Participants did not received 300 mg because the trial was stopped early.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanograms*hour per millilitre (ng*h/mL)
Induction Period: Pre-dose, Day 0, Day 7, Day 14, Day 28, Day 56, Day 112 Post-dose; Maintenance Period:Predose, Day 168; Day 252, Day 364 Post-dose
ID
Title
Description
OG000
50 mg LY3375880
Participants received 50 mg LY3375880 administered SC Q4W.
OG001
150 mg LY3375880
Participants received 150 mg LY3375880 administered SC Q4W.
OG002
600 mg LY3375880
Participants received 600 mg LY3375880 administered SC Q4W.
Time Frame
Baseline Up To 45 Weeks
Description
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo
Induction Period:
Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
0
33
0
33
7
33
EG001
50 mg LY3375880
Induction Period:
Participants received 50 mg LY3375880 administered SC Q4W.
0
35
0
35
9
35
EG002
150 mg LY3375880
Induction Period:
Participants received 150 mg LY3375880 administered SC Q4W.
0
34
0
34
12
34
EG003
600 mg LY3375880
Induction Period:
Participants received 600 mg LY3375880 administered SC Q4W.
0
33
2
33
12
33
EG004
Placebo Responder to Placebo/300 mg LY3375880
Maintenance Period:
Participants received placebo administered SC Q4W until loss of response then 300 mg LY3375880 SC Q4W .
Participants had received placebo SC Q4W during the induction period.
0
4
0
4
1
4
EG005
Placebo Non-Responder to 300 mg LY3375880
Maintenance Period:
Participants received 300 mg LY3375880 administered SC Q4W.
Participants had received placebo SC Q4W during the induction period.
0
5
1
5
4
5
EG006
50 mg Responder to Placebo/50 mg LY3375880
Maintenance Period:
Participants received placebo administered SC Q4W until loss of response then 50 mg LY3375880 SC Q4W.
Participants had received 50 mg LY3375880 SC Q4W during the induction period.
0
2
0
2
1
2
EG007
50 mg LY3375880 Responder to 50 mg LY3375880
Maintenance Period:
Participants received 50 mg LY3375880 administered SC Q4W.
Participants had received 50 mg LY3375880 SC Q4W during the induction period.
0
4
0
4
1
4
EG008
50 mg LY3375880 Non-Responder to 150 mg LY3375880
Maintenance Period:
Participants received 150 mg LY3375880 administered SC Q4W.
Participants had received 50 mg LY3375880 SC Q4W during the induction period.
0
8
0
8
2
8
EG009
150 mg Responder to Placebo/150 mg LY3375880
Maintenance Period:
Participants received placebo administered SC Q4W until loss of response then 150 mg LY3375880 SC Q4W.
Participants had received 150 mg LY3375880 SC Q4W during the induction period.
0
1
0
1
1
1
EG010
150 mg LY3375880 Responder to 150 mg LY3375880
Maintenance Period:
Participants received 150 mg LY3375880 administered SC Q4W.
Participants had received 150 mg LY3375880 SC Q4W during the induction period.
0
4
0
4
1
4
EG011
150 mg LY3375880 Non-Responder to 300 mg LY3375880
Maintenance Period:
Participants received 300 mg LY3375880 administered SC Q4W.
Participants had received 150 mg LY3375880 SC Q4W during the induction period.
0
8
0
8
3
8
EG012
600 mg Responder to Placebo/600 mg LY3375880
Maintenance Period:
Participants received placebo administered SC Q4W until loss of response then 600 mg LY3375880 SC Q4W.
Participants had received 600 mg LY3375880 SC Q4W during the induction period.
0
1
0
1
0
1
EG013
600 mg LY3375880 Responder to 600 mg LY3375880
Maintenance Period:
Participants received 600 mg LY3375880 administered SC Q4W.
Participants had received 600 mg LY3375880 SC Q4W during the induction period.
0
1
0
1
0
1
EG014
600 mg LY3375880 Non-Responder to 600 mg LY3375880
Maintenance Period:
Participants received 600 mg LY3375880 administered SC Q4W.
Participants had received 600 mg LY3375880 SC Q4W during the induction period.
0
9
0
9
2
9
EG015
LY3375880-50mg-Q4W-Post-Treatment Follow-Up Period
Follow-up: participants did not receive drug during the follow-up period.
0
0
0
0
0
0
EG016
LY3375880-150mg-Q4W-Post-Treatment Follow-Up Period
Follow-up: participants did not receive drug during the follow-up period.
0
0
0
0
0
0
EG017
LY3375880-600mg-Q4W-Post-Treatment Follow-Up Period
Follow-up: participants did not receive drug during the follow-up period.
0
0
0
0
0
0
EG018
Placebo-Post-Treatment Follow-Up Period
Follow-up: participants did not receive drug during the follow-up period.
0
0
0
0
0
0
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cardiac arrest
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected34 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected1 at risk
EG0140 events0 affected9 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
EG0180 events0 affected0 at risk
Cellulitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected34 at risk
EG003
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected34 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected34 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cardiac failure congestive
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected34 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected1 at risk
EG0140 events0 affected9 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
EG0180 events0 affected0 at risk
Cardiomyopathy
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected34 at risk
EG003
Cataract
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected34 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected34 at risk
EG003
Injection site pain
General disorders
MedDRA 21.1
Systematic Assessment
EG0006 events1 affected33 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected34 at risk
EG003
Injection site reaction
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0010 events0 affected35 at risk
EG0022 events1 affected34 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected34 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected33 at risk
EG0011 events1 affected35 at risk
EG0020 events0 affected34 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0013 events3 affected35 at risk
EG0021 events1 affected34 at risk
EG003
Paronychia
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0010 events0 affected35 at risk
EG0022 events2 affected34 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected33 at risk
EG0011 events1 affected35 at risk
EG0024 events3 affected34 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0010 events0 affected35 at risk
EG0021 events1 affected34 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected34 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected34 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected34 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected34 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected34 at risk
EG003
Electrocardiogram qt prolonged
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected34 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected34 at risk
EG003
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected34 at risk
EG003
Headache
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected33 at risk
EG0012 events2 affected35 at risk
EG0020 events0 affected34 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected34 at risk
EG003
Depression
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0011 events1 affected35 at risk
EG0020 events0 affected34 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0002 events2 affected33 at risk
EG0011 events1 affected35 at risk
EG0024 events4 affected34 at risk
EG003
Menstruation irregular
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected17 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected34 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected34 at risk
EG003
Androgenetic alopecia
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected34 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0003 events3 affected33 at risk
EG0011 events1 affected35 at risk
EG0024 events3 affected34 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected34 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0011 events1 affected35 at risk
EG0022 events2 affected34 at risk
EG003
The study was terminated for lack of efficacy after an interim analysis was performed.