A Global Study Comparing Risankizumab to Placebo in Adult... | NCT03926169

ID	Type	Description	Link
2019-000122-21	EudraCT Number

A Global Study Comparing Risankizumab to Placebo in Adult... | NCT03926169 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Risankizumab 180 mg	Experimental	In Period A, participants receive blinded risankizumab 180 mg via a subcutaneous (SC) injection at Weeks 0 (Baseline), 1, 2, 4, and 12.	Drug: Risankizumab
Risankizumab 360 mg	Experimental	In Period A, participants receive blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.	Drug: Risankizumab
Placebo	Placebo Comparator	In Period A, participants receive blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.	Drug: Placebo for risankizumab
Risankizumab 180 mg / Risankizumab 360 mg	Experimental	In Period A, participants receive blinded risankizumab 180 mg via a subcutaneous (SC) injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants receive blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg every 8 weeks (q8w) at Weeks 20, 28, 36, 44, 52, and 60.	Drug: Risankizumab Drug: Placebo for risankizumab
Risankizumab 360 mg / Risankizumab 360 mg	Experimental	In Period A, participants receive blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants receive blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Risankizumab	Drug	Risankizumab is administered as a SC injection in pre-filled syringe (PFS)	Placebo / Risankizumab 360 mg Risankizumab 180 mg Risankizumab 180 mg / Risankizumab 360 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16	HiSCR is defined as at least a 50% reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase in abscess or draining fistula counts.	Baseline (Week 0), Week 16

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in Patient's Global Assessment (PGA) of Skin Pain Numerical Rating Scale (NRS30) at Week 8 Among Participants With Baseline Numerical Rating Scale (NRS) ≥ 3	NRS30 is evaluated based on worst skin pain in a 24-hour recall period (maximal daily pain), ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline at Week 8 in the PGA of Skin Pain (NRS30) - at worst, among participants with Baseline NRS ≥ 3, is presented.

Contacts/Locations Module

Name	Affiliation	Role
ABBVIE INC.	AbbVie	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Burke Pharmaceutical Research /ID# 211671		Hot Springs	Arkansas	71913-6404	United States
Bakersfield Derma & Skin Cance /ID# 211684

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36892753	Derived	Kimball AB, Prens EP, Passeron T, Maverakis E, Turchin I, Beeck S, Drogaris L, Geng Z, Zhan T, Messina I, Bechara FG. Efficacy and Safety of Risankizumab for the Treatment of Hidradenitis Suppurativa: A Phase 2, Randomized, Placebo-Controlled Trial. Dermatol Ther (Heidelb). 2023 May;13(5):1099-1111. doi: 10.1007/s13555-023-00913-3. Epub 2023 Mar 9.

Label	URL
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo / Risankizumab 360 mg	In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants received blinded risankizumab 360 mg at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg every 8 weeks (q8w) at Weeks 20, 28, 36, 44, 52, and 60.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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	Dec 15, 2020	Jul 14, 2022

Type	Comment	Reasons
Adverse Event		FG0002 subjects FG0012 subjects FG0021 subjects
Withdrawal by Subject		FG0002 subjects FG0012 subjects FG0022 subjects
Lost to Follow-up		FG0003 subjects FG0011 subjects FG0020 subjects
Lack of Efficacy		FG0000 subjects FG0012 subjects FG0022 subjects
COVID-19 Infection		FG0000 subjects FG0011 subjects FG0020 subjects
COVID-19 Logistical Restrictions		FG0000 subjects FG0012 subjects FG0021 subjects
Other, Not Specified		FG0001 subjects FG0010 subjects FG0020 subjects

Period B

Type	Comment	Milestone Data
STARTED	Entered Period B	FG00074 subjects FG00170 subjects FG00275 subjects
Entered Period B and Received Study Drug		FG00074 subjects FG00170 subjects FG00274 subjects
COMPLETED	Completed study	FG0004 subjects FG0017 subjects FG0024 subjects
NOT COMPLETED		FG00070 subjects FG00163 subjects FG00271 subjects

Type	Comment	Reasons
Adverse Event		FG0003 subjects FG0011 subjects FG0021 subjects
Withdrawal by Subject		FG000

Arm/Group Information

ID	Title	Description
BG000	Placebo / Risankizumab 360 mg	In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants received blinded risankizumab 360 mg at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg every 8 weeks (q8w) at Weeks 20, 28, 36, 44, 52, and 60.
BG001	Risankizumab 180 mg / Risankizumab 360 mg	In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants received blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.
BG002	Risankizumab 360 mg / Risankizumab 360 mg	In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants received blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.
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
	BG00037.2± 11.97 BG00138.9± 11.45 BG00238.2± 11.99 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00048 BG00153 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Hispanic or Latino

Title	Measurements
	BG0009 BG00110 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG00068 BG00163 BG002

Abscess and Inflammatory Nodule (AN) Count

Mean

Standard Deviation

abscess and inflammatory nodules

Title

Denominators

Categories

Title	Measurements
	BG00015.7± 28.42 BG00113.7± 11.42 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 Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16

HiSCR is defined as at least a 50% reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase in abscess or draining fistula counts.

Intent-to-Treat Population: all randomized participants. Non-responder imputation with multiple imputation to handle missing data due to COVID-19 (NRI-C) .

Posted

Number

97.5% Confidence Interval

percentage of participants

Baseline (Week 0), Week 16

ID	Title	Description
OG000	Placebo	In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
OG001	Risankizumab 180 mg	In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
OG002	Risankizumab 360 mg	In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.

Units	Counts
Participants	OG00082 OG00180 OG00281

Title

Denominators

Categories

Title	Measurements
	OG00041.5(29.3 to 53.7) OG00146.8(34.2 to 59.4) OG00243.4(31.0 to 55.8)

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		Cochran-Mantel-Haenszel		0.422	Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.	Adjusted Response Rate Difference (%)	6.0			2-Sided	97.5	-10.8	22.8					Superiority

Secondary

Percentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in Patient's Global Assessment (PGA) of Skin Pain Numerical Rating Scale (NRS30) at Week 8 Among Participants With Baseline Numerical Rating Scale (NRS) ≥ 3

NRS30 is evaluated based on worst skin pain in a 24-hour recall period (maximal daily pain), ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline at Week 8 in the PGA of Skin Pain (NRS30) - at worst, among participants with Baseline NRS ≥ 3, is presented.

Intent-to-Treat Population: all randomized participants. Participants with Baseline NRS ≥ 3. Non-responder imputation with multiple imputation to handle missing data due to COVID-19.

Posted

Number

97.5% Confidence Interval

percentage of participants

Baseline (Week 0) to Week 8

ID	Title	Description
OG000	Placebo	In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
OG001	Risankizumab 180 mg	In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
OG002	Risankizumab 360 mg

Secondary

Percentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in PGA of Skin Pain Numerical Rating Scale (NRS30) at Week 16 Among Participants With Baseline Numerical Rating Scale (NRS) ≥ 3

NRS30 is evaluated based on worst skin pain in a 24-hour recall period (maximal daily pain), ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline at Week 16 in the PGA of Skin Pain (NRS30) - at worst, among participants with Baseline NRS ≥ 3, is presented.

Intent-to-Treat Population: all randomized participants. Participants with Baseline NRS ≥ 3. Non-responder imputation with multiple imputation to handle missing data due to COVID-19.

Posted

Number

97.5% Confidence Interval

percentage of participants

Baseline (Week 0) to Week 16

ID	Title	Description
OG000	Placebo	In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
OG001	Risankizumab 180 mg	In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
OG002	Risankizumab 360 mg

Secondary

Percentage of Participants Who Experienced ≥ 25% Increase in Abscess and Inflammatory Nodule (AN) Counts in Period A With a Minimum Increase of 2 Relative to Baseline

Intent-to-Treat Population: all randomized participants. Participants with Baseline NRS ≥ 3. Non-responder imputation.

Posted

Number

97.5% Confidence Interval

percentage of participants

Baseline (Week 0) to Week 16

ID	Title	Description
OG000	Placebo	In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
OG001	Risankizumab 180 mg	In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
OG002	Risankizumab 360 mg	In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.

Units	Counts
Participants

Secondary

Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16

The DLQI is a 10-item validated questionnaire used to assess the impact of HS disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. DLQI scores range from 0 to 30, with a higher score indicating a more impaired QoL.

Intent-to-Treat Population: all randomized participants. Participants with an assessment at given time point.

Posted

Least Squares Mean

97.5% Confidence Interval

score on a scale

Baseline (Week 0) to Week 16

ID	Title	Description
OG000	Placebo	In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
OG001	Risankizumab 180 mg	In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
OG002	Risankizumab 360 mg	In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.

Secondary

Change From Baseline in HS-Related Swelling Based on the Hidradenitis Suppurativa Symptom Assessment (HSSA) Swollen Skin Score at Week 16

HSSA is a 9-item participant-reported outcome (PRO) questionnaire developed to assess the symptoms of HS. HS-related swelling is scored on an 11-point NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.

Intent-to-Treat Population: all randomized participants. Participants with an assessment at given time point.

Posted

Least Squares Mean

97.5% Confidence Interval

score on a scale

Baseline (Week 0) to Week 16

ID	Title	Description
OG000	Placebo	In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
OG001	Risankizumab 180 mg	In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
OG002	Risankizumab 360 mg	In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.

Secondary

Change From Baseline in HS-Related Odor Based on the HSSA Bad Smell Score at Week 16

HSSA is a 9-item PRO questionnaire developed to assess the symptoms of HS. HS-related odor is scored on an 11-point NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.

Intent-to-Treat Population: all randomized participants. Participants with an assessment at given time point.

Posted

Least Squares Mean

97.5% Confidence Interval

score on a scale

Baseline (Week 0) to Week 16

ID	Title	Description
OG000	Placebo	In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
OG001	Risankizumab 180 mg	In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
OG002	Risankizumab 360 mg	In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.

Units

Secondary

Change From Baseline in HS-Related Worst Drainage Based on the HSSA Worst Drainage Score at Week 16

HSSA is a 9-item PRO questionnaire developed to assess the symptoms of HS. HS-related worst drainage is scored on an 11-point NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.

Intent-to-Treat Population: all randomized participants. Participants with an assessment at given time point.

Posted

Least Squares Mean

97.5% Confidence Interval

score on a scale

Baseline (Week 0) to Week 16

ID	Title	Description
OG000	Placebo	In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
OG001	Risankizumab 180 mg	In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
OG002	Risankizumab 360 mg	In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	In Period A, participants received blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.	82	2	82	19	82
EG001	Risankizumab 180 mg	In Period A, participants received blinded risankizumab 180 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.	80	3	80	21	80
EG002	Risankizumab 360 mg	In Period A, participants received blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.	80	2	80	26	80
EG003	Placebo / Risankizumab 360 mg	In Period A, participants received blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants received blinded risankizumab 360 mg at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg every 8 weeks (q8w) at Weeks 20, 28, 36, 44, 52, and 60.	74	3	74	26	74
EG004	Risankizumab 180 mg / Risankizumab 360 mg	In Period A, participants received blinded risankizumab 180 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants received blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.	70	4	70	12	70
EG005	Risankizumab 360 mg / Risankizumab 360 mg	In Period A, participants received blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants received blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.	74	0	74	19	74

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANGINA UNSTABLE	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected80 at risk EG0020 events0 affected80 at risk EG0030 events0 affected74 at risk EG0040 events0 affected70 at risk EG0050 events0 affected74 at risk
SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected80 at risk EG0021 events1 affected80 at risk EG003
APPENDICITIS	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected80 at risk EG0020 events0 affected80 at risk EG003
COVID-19 PNEUMONIA	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected80 at risk EG0020 events0 affected80 at risk EG003
CELLULITIS	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected80 at risk EG0020 events0 affected80 at risk EG003
SUBCUTANEOUS ABSCESS	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected80 at risk EG0020 events0 affected80 at risk EG003
TONSILLITIS	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected80 at risk EG0020 events0 affected80 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected80 at risk EG0020 events0 affected80 at risk EG003
INTERVERTEBRAL DISC PROTRUSION	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected80 at risk EG0020 events0 affected80 at risk EG003
BREAST CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected80 at risk EG0020 events0 affected80 at risk EG003
AFFECTIVE DISORDER	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected80 at risk EG0021 events1 affected80 at risk EG003
INTENTIONAL SELF-INJURY	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected80 at risk EG0021 events1 affected80 at risk EG003
MAJOR DEPRESSION	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected80 at risk EG0021 events1 affected80 at risk EG003
SUICIDAL IDEATION	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected80 at risk EG0021 events1 affected80 at risk EG003
ENDOMETRIOSIS	Reproductive system and breast disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected80 at risk EG0020 events0 affected80 at risk EG003
OVARIAN CYST	Reproductive system and breast disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected80 at risk EG0020 events0 affected80 at risk EG003
HIDRADENITIS	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected80 at risk EG0020 events0 affected80 at risk EG003
ABORTION INDUCED	Surgical and medical procedures	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected80 at risk EG0020 events0 affected80 at risk EG003
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected80 at risk EG0020 events0 affected80 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
DIARRHOEA	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0004 events4 affected82 at risk EG0012 events2 affected80 at risk EG0024 events2 affected80 at risk EG0035 events5 affected74 at risk EG0041 events1 affected70 at risk EG0052 events2 affected74 at risk
NASOPHARYNGITIS	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected82 at risk EG0016 events6 affected80 at risk EG0028 events7 affected80 at risk EG003
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected82 at risk EG0011 events1 affected80 at risk EG0024 events4 affected80 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected82 at risk EG0014 events4 affected80 at risk EG0023 events3 affected80 at risk EG003
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected82 at risk EG0013 events3 affected80 at risk EG0024 events4 affected80 at risk EG003
HEADACHE	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG00016 events9 affected82 at risk EG0016 events6 affected80 at risk EG00215 events11 affected80 at risk EG003
ECZEMA	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected80 at risk EG0022 events2 affected80 at risk EG003
HIDRADENITIS	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0007 events7 affected82 at risk EG0013 events3 affected80 at risk EG0023 events2 affected80 at risk EG003

Ancestor Terms

ID	Term
D017192	Skin Diseases, Bacterial
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D012874	Skin Diseases, Infectious
D013492	Suppuration
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D016575	Hidradenitis
D013543	Sweat Gland Diseases

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		Cochran-Mantel-Haenszel		0.725	Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.	Adjusted Response Rate Difference (%)	-3.0			2-Sided	97.5	-21.8	15.9					Superiority
OG000 OG002		Cochran-Mantel-Haenszel		0.301	Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.	Adjusted Response Rate Difference (%)	8.8			2-Sided	97.5	-10.3	27.8					Superiority

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		Cochran-Mantel-Haenszel		0.650	Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.	Adjusted Response Rate Difference (%)	3.7			2-Sided	97.5	-14.5	21.8					Superiority
OG000 OG002		Cochran-Mantel-Haenszel		0.147	Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.	Adjusted Response Rate Difference (%)	12.3			2-Sided	97.5	-6.7	31.3					Superiority

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		Cochran-Mantel-Haenszel		0.342	Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.	Adjusted Response Rate Difference (%)	-6.5			2-Sided	97.5	-21.8	8.8					Superiority
OG000 OG002		Cochran-Mantel-Haenszel		0.108	Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.	Adjusted Response Rate Difference (%)	-10.6			2-Sided	97.5	-25.3	4.2					Superiority

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		mixed-effect model repeat measures		0.179	Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.	LS Mean Difference	-1.3	Standard Error of the Mean	0.97	2-Sided	97.5	-3.5	0.9					Superiority
OG000 OG002		mixed-effect model repeat measures		0.105	Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.	LS Mean Difference	-1.6	Standard Error of the Mean	0.98	2-Sided	97.5	-3.8	0.6					Superiority

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		mixed-effect model repeat measures		0.727	Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.	LS Mean Difference	0.118	Standard Error of the Mean	0.3385	2-Sided	97.5	-0.646	0.883					Superiority
OG000 OG002		mixed-effect model repeat measures		0.963	Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.	LS Mean Difference	-0.015	Standard Error of the Mean	0.3273	2-Sided	97.5	-0.755	0.724					Superiority

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		mixed-effect model repeat measures		0.886	Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.	LS Mean Difference	0.042	Standard Error of the Mean	0.2941	2-Sided	97.5	-0.622	0.706					Superiority
OG000 OG002		mixed-effect model repeat measures		0.409	Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.	LS Mean Difference	0.236	Standard Error of the Mean	0.2851	2-Sided	97.5	-0.408	0.879					Superiority

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		mixed-effect model repeat measures		0.434	Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.	LS Mean Difference	-0.252	Standard Error of the Mean	0.3212	2-Sided	97.5	-0.977	0.473					Superiority
OG000 OG002		mixed-effect model repeat measures		0.813	Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.	LS Mean Difference	-0.074	Standard Error of the Mean	0.3123	2-Sided	97.5	-0.779	0.631					Superiority