Study to Evaluate Safety and Efficacy of Filgotinib and L... | NCT03134222

NCT03134222

Status Module

Sponsor/Collaborators Module

Name	Class
Lakefront Biotherapeutics NV	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lanraplenib 30 mg	Experimental	Lanraplenib + filgotinib placebo for 48 weeks	Drug: Lanraplenib Drug: Filgotinib placebo
Filgotinib 200 mg	Experimental	Filgotinib + lanraplenib placebo for 48 weeks	Drug: Filgotinib Drug: Lanraplenib placebo
Placebo	Placebo Comparator	Filgotinib placebo + lanraplenib placebo for 12 weeks	Drug: Lanraplenib placebo Drug: Filgotinib placebo
Placebo to Lanraplenib 30 mg	Experimental	After Week 12 Visit, participants on placebo will be rerandomized 1:1 and receive lanraplenib + filgotinib placebo in a blinded fashion through Week 48.	Drug: Lanraplenib Drug: Filgotinib placebo
Placebo to Filgotinib 200 mg	Experimental	After Week 12 Visit, participants on placebo will be rerandomized 1:1 and receive filgotinib + lanraplenib placebo in a blinded fashion through Week 48.	Drug: Filgotinib Drug: Lanraplenib placebo

Name	Type	Description	Arm Group Labels	Other Names
Lanraplenib	Drug	30 mg tablets administered orally once daily with or without food	Lanraplenib 30 mg Placebo to Lanraplenib 30 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score From Baseline to Week 12	CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area. The total score ranges from 0-70, with higher scores indicating more severe skin disease.	Baseline; Week 12

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants at Week 12 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline	CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area. The total score ranges from 0-70, with higher scores indicating more severe skin disease.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Gilead Study Director	Gilead Sciences	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Wallace Rheumatic Studies Center		Beverly Hills	California	90211	United States
St. Jude Hospital Yorba Linda DBA Dr. Joseph Heritage Healthcare

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34498056	Derived	Werth VP, Fleischmann R, Robern M, Touma Z, Tiamiyu I, Gurtovaya O, Pechonkina A, Mozaffarian A, Downie B, Matzkies F, Wallace D. Filgotinib or lanraplenib in moderate to severe cutaneous lupus erythematosus: a phase 2, randomized, double-blind, placebo-controlled study. Rheumatology (Oxford). 2022 May 30;61(6):2413-2423. doi: 10.1093/rheumatology/keab685.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Lanraplenib 30 mg	Lanraplenib 30 mg + filgotinib placebo tablets orally once daily for 48 weeks
FG001	Filgotinib 200 mg	Filgotinib 200 mg + lanraplenib placebo tablets orally once daily for 48 weeks

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 15, 2018	Feb 3, 2020

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Masking Info

FG00019 subjects
FG00118 subjects
FG00210 subjects
FG0030 subjects
FG0040 subjects

The Safety Analysis Set included all participants who received at least 1 dose of study drug.

Arm/Group Information

ID	Title	Description
BG000	Lanraplenib 30 mg	Lanraplenib 30 mg + filgotinib placebo tablets orally once daily for 48 weeks
BG001	Filgotinib 200 mg	Filgotinib 200 mg + lanraplenib placebo tablets orally once daily for 48 weeks
BG002	Placebo	Participants received filgotinib placebo + lanraplenib placebo tablets orally once daily for 12 weeks. After Week 12 Visit, participants were rerandomized 1:1 and received filgotinib 200 mg + lanraplenib placebo or lanraplenib 30 mg + filgotinib placebo once daily in a blinded fashion through Week 48.
BG003	Total	Total of all reporting groups

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
	BG00051± 9.0 BG00143± 11.5 BG00246± 7.3 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00019 BG00117 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001 BG0010 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0003 BG0014 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Canada

Title	Measurements
	BG0004 BG0011 BG002

Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score

CLASI Activity score ranges from 0-70, higher scores indicate more severe skin disease. For additional details on this index, please see Outcome Measure#1.

Measure Analysis Population Description: Participants in the Full Analysis Set (who were randomized and received at least one dose of study drug (filgotinib, lanraplenib or placebo) were analyzed.

Mean

Standard Deviation

score on a scale

Title

Denominators

Categories

Title	Measurements
	BG00017.1± 6.11 BG001

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

Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score From Baseline to Week 12

CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area. The total score ranges from 0-70, with higher scores indicating more severe skin disease.

Treatment policy-estimand is the primary estimand for the primary endpoint analysis which involved participants in the Full Analysis Set (who were randomized and received at least one dose of study drug [filgotinib, lanraplenib or placebo]) with available data.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline; Week 12

ID	Title	Description
OG000	Lanraplenib 30 mg	Lanraplenib 30 mg + filgotinib placebo tablets orally once daily for 48 weeks
OG001	Filgotinib 200 mg	Filgotinib 200 mg + lanraplenib placebo tablets orally once daily for 48 weeks
OG002	Placebo	Participants received filgotinib placebo + lanraplenib placebo tablets orally once daily for 12 weeks.

Units	Counts
Participants	OG00016 OG00116 OG0028

Title

Denominators

Categories

Title	Measurements
	OG000-4.5± 1.91 OG001-8.7± 1.85 OG002-5.5± 2.56

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 OG002		Mixed-effect repeated measures model		0.7500														Superiority
OG001 OG002		Mixed-effect repeated measures model		0.3047

Secondary

Percentage of Participants at Week 12 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline

Participants in the Full Analysis Set were analyzed. Missing data are imputed as No Response.

Posted

Number

95% Confidence Interval

Percentage of participants

Baseline; Week 12

ID	Title	Description
OG000	Lanraplenib 30 mg	Lanraplenib 30 mg + filgotinib placebo tablets orally once daily for 48 weeks
OG001	Filgotinib 200 mg	Filgotinib 200 mg + lanraplenib placebo tablets orally once daily for 48 weeks
OG002	Placebo	Participants received filgotinib placebo + lanraplenib placebo tablets orally once daily for 12 weeks.

Secondary

Percentage of Participants at Week 12 With No Worsening in CLASI Activity Score From Baseline

Participants in the Full Analysis Set were analyzed. Missing data are imputed as No Response.

Posted

Number

95% Confidence Interval

Percentage of participants

Baseline; Week 12

ID	Title	Description
OG000	Lanraplenib 30 mg	Lanraplenib 30 mg + filgotinib placebo tablets orally once daily for 48 weeks
OG001	Filgotinib 200 mg	Filgotinib 200 mg + lanraplenib placebo tablets orally once daily for 48 weeks
OG002	Placebo	Participants received filgotinib placebo + lanraplenib placebo tablets orally once daily for 12 weeks.

Secondary

Percentage of Participants at Week 24 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline

Participants in the Full Analysis Set who were randomized to Filgotinib 200 mg or Lanraplenib 200 mg.

Posted

Number

95% Confidence Interval

Percentage of participants

Baseline; Week 24

ID	Title	Description
OG000	Lanraplenib 30 mg	Lanraplenib 30 mg + filgotinib placebo tablets orally once daily for 48 weeks
OG001	Filgotinib 200 mg	Filgotinib 200 mg + lanraplenib placebo tablets orally once daily for 48 weeks

Units	Counts
Participants

Secondary

Percentage of Participants at Week 24 With No Worsening in CLASI Activity Score From Baseline

Participants in the Full Analysis Set who were randomized to Filgotinib 200 mg or Lanraplenib 200 mg.

Posted

Number

95% Confidence Interval

Percentage of participants

Baseline; Week 24

ID	Title	Description
OG000	Lanraplenib 30 mg	Lanraplenib 30 mg + filgotinib placebo tablets orally once daily for 48 weeks
OG001	Filgotinib 200 mg	Filgotinib 200 mg + lanraplenib placebo tablets orally once daily for 48 weeks

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Lanraplenib 30 mg	Lanraplenib 30 mg + filgotinib placebo tablets orally once daily for 48 weeks	19	2	19	17	19
EG001	Filgotinib 200 mg	Filgotinib 200 mg + lanraplenib placebo tablets orally once daily for 48 weeks	17	1	17	11	17
EG002	Placebo	Participants received filgotinib placebo + lanraplenib placebo tablets orally once daily for 12 weeks.	9	0	9	6	9
EG003	Placebo to Lanraplenib 30 mg	After Week 12 Visit, participants on placebo were rerandomized 1:1 and received lanraplenib 30 mg + filgotinib placebo once daily in a blinded fashion through Week 48.	4	0	4	3	4
EG004	Placebo to Filgotinib 200 mg	After Week 12 Visit, participants on placebo were rerandomized 1:1 and received filgotinib 200 mg + lanraplenib placebo once daily in a blinded fashion through Week 48.	4	0	4	3	4

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Coronary artery occlusion	Cardiac disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected17 at risk EG0020 affected9 at risk EG0030 affected4 at risk EG0040 affected4 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected17 at risk EG0020 affected9 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected17 at risk EG0020 affected9 at risk EG0030 affected4 at risk EG0040 affected4 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Dry eye	Eye disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected17 at risk EG0020 affected9 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Aphthous ulcer	Gastrointestinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected17 at risk EG0020 affected9 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0002 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected17 at risk EG0020 affected9 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected17 at risk EG0020 affected9 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0002 affected19 at risk EG0013 affected17 at risk EG0020 affected9 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected17 at risk EG0020 affected9 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 affected19 at risk EG0012 affected17 at risk EG0020 affected9 at risk EG003
Chest pain	General disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected17 at risk EG0021 affected9 at risk EG003
Fatigue	General disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 affected19 at risk EG0012 affected17 at risk EG0020 affected9 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Oedema peripheral	General disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Pyrexia	General disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected17 at risk EG0020 affected9 at risk EG003
Acne pustular	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Bronchitis	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0002 affected19 at risk EG0010 affected17 at risk EG0020 affected9 at risk EG003
Cystitis	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected17 at risk EG0020 affected9 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected17 at risk EG0020 affected9 at risk EG003
Herpes zoster	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected17 at risk EG0020 affected9 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected17 at risk EG0020 affected9 at risk EG003
Oral herpes	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected17 at risk EG0020 affected9 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Otitis externa	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected17 at risk EG0020 affected9 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected17 at risk EG0020 affected9 at risk EG003
Sinusitis	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0012 affected17 at risk EG0020 affected9 at risk EG003
Tonsillitis	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0004 affected19 at risk EG0013 affected17 at risk EG0022 affected9 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0003 affected19 at risk EG0012 affected17 at risk EG0020 affected9 at risk EG003
Viral pharyngitis	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Vulvovaginal mycotic infection	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0001 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Corneal abrasion	Injury, poisoning and procedural complications	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected17 at risk EG0021 affected9 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0012 affected17 at risk EG0020 affected9 at risk EG003
Foreign body	Injury, poisoning and procedural complications	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Tooth fracture	Injury, poisoning and procedural complications	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected17 at risk EG0020 affected9 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA Version 22.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected17 at risk EG0020 affected9 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA Version 22.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected17 at risk EG0020 affected9 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA Version 22.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected17 at risk EG0020 affected9 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA Version 22.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected17 at risk EG0020 affected9 at risk EG003
Liver function test increased	Investigations	MedDRA Version 22.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected17 at risk EG0020 affected9 at risk EG003
Vitamin D decreased	Investigations	MedDRA Version 22.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected17 at risk EG0020 affected9 at risk EG003
Weight increased	Investigations	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected17 at risk EG0021 affected9 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Iron deficiency	Metabolism and nutrition disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 affected19 at risk EG0012 affected17 at risk EG0020 affected9 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected17 at risk EG0021 affected9 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected17 at risk EG0020 affected9 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 22.0	Systematic Assessment	EG0002 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Carpal tunnel syndrome	Nervous system disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Cognitive disorder	Nervous system disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected17 at risk EG0021 affected9 at risk EG003
Headache	Nervous system disorders	MedDRA Version 22.0	Systematic Assessment	EG0002 affected19 at risk EG0014 affected17 at risk EG0020 affected9 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected17 at risk EG0020 affected9 at risk EG003
Migraine	Nervous system disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected17 at risk EG0021 affected9 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected17 at risk EG0020 affected9 at risk EG003
Sinus headache	Nervous system disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Uterine mass	Reproductive system and breast disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected17 at risk EG0021 affected9 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected17 at risk EG0021 affected9 at risk EG003
Paranasal sinus discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected17 at risk EG0020 affected9 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 affected19 at risk EG0012 affected17 at risk EG0020 affected9 at risk EG003
Sinus pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected17 at risk EG0020 affected9 at risk EG003
Rosacea	Skin and subcutaneous tissue disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected17 at risk EG0021 affected9 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected17 at risk EG0020 affected9 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected17 at risk EG0020 affected9 at risk EG003
Tooth extraction	Surgical and medical procedures	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected17 at risk EG0020 affected9 at risk EG003
Haematoma	Vascular disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected17 at risk EG0020 affected9 at risk EG003
Hypertension	Vascular disorders	MedDRA Version 22.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected17 at risk EG0020 affected9 at risk EG003

First MCP Posted Date

ID	Term
D008178	Lupus Erythematosus, Cutaneous

ID	Term
C584571	GLPG0634

Units	Counts
Participants	OG00019 OG00117 OG0029

EG0040 affected4 at risk

EG0041 affected4 at risk

EG0040 affected4 at risk

EG0041 affected4 at risk

EG0040 affected4 at risk

EG0041 affected4 at risk

EG0040 affected4 at risk

EG0041 affected4 at risk

EG0040 affected4 at risk

EG0041 affected4 at risk

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D012871	Skin Diseases