Double-Blinded, Placebo-Controlled Phase 1b Study for Saf... | NCT03943550

ID	Type	Description	Link
2017-004599-74	EudraCT Number

Status Module

Label	Type	Description	Intervention Names
RO7049665	Experimental	Participants will receive a subcutaneous (SC) dose of RO7049665 every 2 weeks for 4 doses.	Drug: RO7049665
Placebo	Placebo Comparator	Participants will receive a SC dose of matching placebo every 2 weeks for 4 doses.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
RO7049665	Drug	Multiple ascending doses of RO7049665 will be administered SC.	RO7049665

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE was defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect. Severity of AEs were graded according to NCI CTCAE v4.0.	From baseline up to safety follow-up visit on Day 99

Secondary Outcomes

Measure	Description	Time Frame
Time to Maximum Concentration (Tmax) of RO7049665		Day 1 to Day 15 (predose) and Day 43 (post-dose)
Maximum Serum Concentration Observed (Cmax) of RO7049665		Days 1 and 43: Pre-dose, 6 h and 12 h post-dose

Eligibility Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Jacksonville Center for Clinical Research		Jacksonville	Florida	32216	United States
The Research Institute of Clinical Medicine

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants received RO7049665 matching placebo, as subcutaneous (SC) injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.
FG001	RO7049665 3.5 mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Nov 20, 2020

ID	Title	Description
BG000	Placebo	Participants received RO7049665 matching placebo, as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.
BG001	RO7049665 3.5 mg	Participants received RO7049665, 3.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.
BG002	RO7049665 7.5 mg	Participants received RO7049665, 7.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG0009 BG0019 BG00227 BG00345

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

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE was defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect. Severity of AEs were graded according to NCI CTCAE v4.0.

Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.

Posted

Count of Participants

Participants

From baseline up to safety follow-up visit on Day 99

ID	Title	Description
OG000	Placebo	Participants received RO7049665 matching placebo, as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.
OG001	RO7049665 3.5 mg	Participants received RO7049665, 3.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.
OG002	RO7049665 7.5 mg	Participants received RO7049665, 7.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.

Units	Counts
Participants	OG0009 OG0019 OG00227

Title

Denominators

Categories

Number of participants with at least 1 AE

Title	Measurements
	OG0004 OG0016 OG00224

Number of participants with at least one SAE

Secondary

Time to Maximum Concentration (Tmax) of RO7049665

Pharmacokinetic (PK) analysis population included participants who had received active treatment. Number analyzed is the number of participants with evaluable data at specified timepoint.

Posted

Median

Full Range

hour (h)

Day 1 to Day 15 (predose) and Day 43 (post-dose)

ID	Title	Description
OG000	RO7049665 3.5 mg	Participants received RO7049665, 3.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.
OG001	RO7049665 7.5 mg	Participants received RO7049665, 7.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.

Units	Counts
Participants	OG000

Secondary

Maximum Serum Concentration Observed (Cmax) of RO7049665

Pharmacokinetic (PK) analysis population included participants who had received active treatment. Number analyzed is the number of participants with evaluable data at specified timepoint.

Posted

Geometric Mean

Full Range

nanograms per milliliters (ng/mL)

Days 1 and 43: Pre-dose, 6 h and 12 h post-dose

ID	Title	Description
OG000	RO7049665 3.5 mg	Participants received RO7049665, 3.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.
OG001	RO7049665 7.5mg	Participants received RO7049665, 7.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.

Units	Counts
Participants	OG000

Secondary

Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUCinf) of RO7049665

PK analysis population included participants who had received active treatment. Number analyzed is the number of participants with evaluable data at specified timepoint.

Posted

Geometric Mean

Full Range

h*ng/mL

Days 1 and 43: Pre-dose, 6 h and 12 h post-dose

ID	Title	Description
OG000	RO7049665 3.5 mg	Participants received RO7049665, 3.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.
OG001	RO7049665 7.5 mg	Participants received RO7049665, 7.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in the Endoscopy Subscore of the Mayo Clinic Score (MCS-ES)

The Mayo Clinic Score (MCS) ranges from 0 to 12 and is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy (i.e., centrally read MCS-ES) and Physician Global Assessment (PGA). Flexible sigmoidoscopy (or colonoscopy) was centrally read and scored using the MCS-ES scoring systems. The disease was considered as endoscopic normal or inactive if the MCS-ES (centrally read) was 0, mild (erythema, decreased vascular pattern) if MCS-ES was 1, moderate (marked erythema, absent vascular pattern, erosions) if MCS-ES was 2 and severe (spontaneous bleeding, ulceration) if MCS-ES was 3. The Endoscopy Subscore of the Mayo Score was modified so that a value of 1 did not include friability. A negative change from baseline indicates improvement.

ITT population included all randomized participants. Number analyzed is the number of participants with evaluable data at specified timepoint.

Posted

Mean

Standard Deviation

score on a scale

Baseline, Days 29 and 57

ID	Title	Description
OG000	Placebo	Participants received RO7049665 matching placebo, as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.
OG001	RO7049665 3.5 mg	Participants received RO7049665, 3.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.

Secondary

Change From Baseline in the Ulcerative Colitis Endoscopic Index of Severity (UCEIS)

Flexible sigmoidoscopy (or colonoscopy) were centrally read and scored using the UCEIS scoring systems. The UCEIS total score is a sum of 3 assessments: Bleeding (scored 0-3), Erosion and Ulcers (scored 0-3), and Vascular Pattern (scored 0-2). The total score ranges from 0-8, with higher score indicating more severe disease. A negative change from baseline indicates improvement.

ITT population included all randomized participants. Number analyzed is the number of participants with evaluable data at specified timepoint.

Posted

Mean

Standard Deviation

score on a scale

Baseline, Days 29 and 57

ID	Title	Description
OG000	Placebo	Participants received RO7049665 matching placebo, as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.
OG001	RO7049665 3.5 mg	Participants received RO7049665, 3.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.
OG002	RO7049665 7.5 mg	Participants received RO7049665, 7.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.

Secondary

Change From Baseline in Histology Score of Sigmoid Colon Biopsies Using Geboes Score (GS)

Mucosal biopsies were obtained during flexible sigmoidoscopy from the most affected area 10 to 20 centimeters (cm) from the anal verge. Biopsies were assessed by standard histology for changes in the inflammatory activity as measured using GS. The GS is a stepwise grading system used for the evaluation of microscopic inflammation and histopathologic disease activity in UC. The microscopic appearance of the mucosa is categorized into 6 grades: Grade 0: architectural changes, Grade 1: chronic inflammatory infiltrate, Grade 2: lamina propria neutrophils and eosinophils, Grade 3: neutrophils in epithelium, Grade 4: crypt destruction and erosions or Grade 5: ulcerations, and each grade of the score is divided in 4 subcategories. A decrease of the Geboes grading system to Grades 0 or 1 would indicate mucosal healing.

ITT population included all randomized participants. Number analyzed is the number of participants with evaluable data at specified timepoint.

Posted

Mean

Standard Deviation

score on a scale

Baseline, Days 29 and 57

ID	Title	Description
OG000	Placebo	Participants received RO7049665 matching placebo, as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.
OG001	RO7049665 3.5 mg	Participants received RO7049665, 3.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.

Secondary

Change From Baseline in Histology Score of Sigmoid Colon Biopsies Using Robarts Histology Index (RHI)

Mucosal biopsies were obtained during flexible sigmoidoscopy from the most affected area 10 to 20 cm from the anal verge. Biopsies were assessed by standard histology for changes in the inflammatory activity as measured using RIH. The RHI is an evaluative index, derived from the Geboes score and is designed to be reproducible and responsive to clinically meaningful change in disease activity over time. The total RHI score ranges from 0 (no disease activity) to 33 (severe disease activity). A negative change from baseline indicates improvement.

ITT population included all randomized participants. Number analyzed is the number of participants with evaluable data at specified timepoint.

Posted

Mean

Standard Deviation

score on a scale

Baseline, Days 29 and 57

ID	Title	Description
OG000	Placebo	Participants received RO7049665 matching placebo, as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.
OG001	RO7049665 3.5 mg	Participants received RO7049665, 3.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.
OG002	RO7049665 7.5 mg

Secondary

Change From Baseline in Histology Score of Sigmoid Colon Biopsies Using Nancy Histology Index (NHI)

Mucosal biopsies were obtained during flexible sigmoidoscopy from the most affected area 10 to 20 cm from the anal verge. Biopsies were assessed by standard histology for changes in the inflammatory activity as measured using NHI. NHI is a validated index for assessing histological disease activity in UC. It is composed of three histological items defining five grades of disease activity: absence of significant histological disease (Grade 0), chronic inflammatory infiltrate with no acute inflammatory infiltrate (Grade 1), mildly active disease (Grade 2), moderately active disease (Grade 3), and severely active disease (Grade 4). The presence of ulceration on the biopsy specimen corresponds to severely active disease (Grade 4). A decrease of the NHI grading system to Grades 0 or 1 would indicate improvement.

ITT population included all randomized participants. Number analyzed is the number of participants with evaluable data at specified timepoint.

Posted

Mean

Standard Deviation

score on a scale

Baseline, Days 29 and 57

ID	Title	Description
OG000	Placebo	Participants received RO7049665 matching placebo, as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.
OG001	RO7049665 3.5 mg	Participants received RO7049665, 3.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.

Secondary

Percentage of Participants With Mayo Clinic Score (MCS) Clinical Response

The MCS ranges from 0 to 12 and is a composite of 4 assessments: stool frequency, rectal bleeding, endoscopy (i.e., centrally read MCS-ES) and Physician Global Assessment (PGA). Each assessment was rated from 0-3, with higher score indicating more severe disease. Clinical response was defined as a decrease in the MCS of at least 3 points and at least 30% decrease from baseline.

ITT population included all randomized participants. Number analyzed is the number of participants with evaluable data at specified timepoint.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline, Days 29 and 57

ID	Title	Description
OG000	Placebo	Participants received RO7049665 matching placebo, as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.
OG001	RO7049665 3.5 mg	Participants received RO7049665, 3.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.
OG002	RO7049665 7.5mg	Participants received RO7049665, 7.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.

Secondary

Number of Participants With Anti-Drug Antibodies (ADAs)

ADA assays was used to detect anti-drug antibodies against RO7049665. Samples which were positive for anti-drug antibodies were further assessed using a neutralizing antibody assay. Participants were considered ADA positive if they were ADA negative at baseline but developed an ADA response following study drug administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 4-fold (treatment-enhanced ADA response).

Immunogenicity population included all participants who had at least one pre-dose and one post-dose ADA assessment.

Posted

Count of Participants

Participants

Baseline; Post-dose on Days 8, 22, 57, 71 and 99; Pre-dose on Days 15, 29 and 43

ID	Title	Description
OG000	Placebo	Participants received RO7049665 matching placebo, as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.
OG001	RO7049665 3.5 mg	Participants received RO7049665, 3.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.
OG002	RO7049665 7.5 mg

Secondary

Change From Baseline in White Blood Cells (Tregs, Teffs)

Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Number analyzed is the number of participants with evaluable data at specified timepoint.

Posted

Mean

Standard Deviation

cells/µl

Baseline; Pre-dose: Days 15, 29 and 43; Post-dose: Days 2, 6, 8, 10, 22, 36, 48, 50, 52, 57, 71

ID	Title	Description
OG000	Placebo	Participants received RO7049665 matching placebo, as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.
OG001	RO7049665 3.5 mg	Participants received RO7049665, 3.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.
OG002	RO7049665 7.5 mg	Participants received RO7049665, 7.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.

Units	Counts

Secondary

Change From Baseline in White Blood Cells (Natural Killer (NK) Cells)

Posted

Mean

Standard Deviation

cells/µl

Baseline; Pre-dose: Days 15, 29 and 43; Post-dose: Days 2, 6, 8, 10, 22, 36, 48, 50, 52, 57, 71

ID	Title	Description
OG000	Placebo	Participants received RO7049665 matching placebo, as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.
OG001	RO7049665 3.5 mg	Participants received RO7049665, 3.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.
OG002	RO7049665 7.5 mg	Participants received RO7049665, 7.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.

Units	Counts

Secondary

Change From Baseline in White Blood Cells (B Cells)

Posted

Mean

Standard Deviation

cells/µl

Baseline; Pre-dose: Days 15, 29 and 43; Post-dose: Days 2, 6, 8, 10, 22, 36, 48, 50, 52, 57, 71

ID	Title	Description
OG000	Placebo	Participants received RO7049665 matching placebo, as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.
OG001	RO7049665 3.5 mg	Participants received RO7049665, 3.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.
OG002	RO7049665 7.5 mg	Participants received RO7049665, 7.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.

Units	Counts

Secondary

Change From Baseline in Eosinophils

Posted

Mean

Standard Deviation

10^9/L

Baseline; Pre-dose: Days 15, 29 and 43; Post-dose: Days 2, 8, 22, 36, 57, 71 and follow-up visit on Day 99

ID	Title	Description
OG000	Placebo	Participants received RO7049665 matching placebo, as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.
OG001	RO7049665 3.5 mg	Participants received RO7049665, 3.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.
OG002	RO7049665 7.5 mg	Participants received RO7049665, 7.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.

Units	Counts

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected9 at risk EG0012 events1 affected9 at risk EG0022 events2 affected27 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected9 at risk EG00215 events13 affected27 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected9 at risk EG0021 events1 affected27 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected9 at risk EG0022 events2 affected27 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected9 at risk EG0020 events0 affected27 at risk
Nausea	Gastrointestinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0012 events2 affected9 at risk EG0020 events0 affected27 at risk
Injection site reaction	General disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected9 at risk EG00117 events5 affected9 at risk EG00249 events18 affected27 at risk
Oedema peripheral	General disorders	MedDRA version: 24.1	Systematic Assessment	EG0002 events1 affected9 at risk EG0010 events0 affected9 at risk EG0020 events0 affected27 at risk
Gastroenteritis	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected9 at risk EG0020 events0 affected27 at risk
Oral herpes	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected9 at risk EG0020 events0 affected27 at risk
Urinary tract infection	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected9 at risk EG0020 events0 affected27 at risk
Injection related reaction	Injury, poisoning and procedural complications	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected9 at risk EG0024 events2 affected27 at risk
Alanine aminotransferase increased	Investigations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected9 at risk EG0022 events2 affected27 at risk
Aspartate aminotransferase increased	Investigations	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected9 at risk EG0020 events0 affected27 at risk
Platelet count decreased	Investigations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected9 at risk EG0020 events0 affected27 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected9 at risk EG0022 events2 affected27 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected9 at risk EG0021 events1 affected27 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected9 at risk EG0020 events0 affected27 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected9 at risk EG0020 events0 affected27 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA version: 24.1	Systematic Assessment	EG0002 events1 affected9 at risk EG0010 events0 affected9 at risk EG0020 events0 affected27 at risk
Headache	Nervous system disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected9 at risk EG0022 events2 affected27 at risk
Insomnia	Psychiatric disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected9 at risk EG0020 events0 affected27 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected9 at risk EG0020 events0 affected27 at risk

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D015212	Inflammatory Bowel Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received RO7049665 matching placebo, as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.	9	0	9	4	9
EG001	RO7049665 3.5 mg	Participants received RO7049665, 3.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.	9	0	9	6	9
EG002	RO7049665 7.5 mg	Participants received RO7049665, 7.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.	27	1	27	23	27