Trial Outcomes & Findings for An International Multicenter, Randomized, Double-blind, Placebo-Controlled Clinical Study of Efficacy and Safety of Two Dosing Regimens of BCD-085 (JSC BIOCAD, Russia) in Patients With Moderate to Severe Plaque Psoriasis (NCT NCT03390101)

Last Updated: 2022-06-01

Results Overview

The Psoriasis Area and Severity Index (PASI) allows evaluating the extent and severity of skin symptoms of psoriasis. Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI: 0 (no disease) to 72 (maximal disease). Relative (percentage) change in PASI score from baseline (screening) is calculated as 100 x (baseline value - time point t value) / (baseline value) PASI 75 indicates a 75% or greater reduction in PASI scores from baseline and is indicative of excellent disease improvement.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

213 participants

Primary outcome timeframe

week 12

Results posted on

2022-06-01

Participant Flow

Participant milestones

Participant milestones
Measure	BCD-085 Q2W Patients in this arm (85 subjects) will receive 120 mg BCD-085 (two SC injections, 60 mg in 1.0 mL each). Thus, the drug will be administered on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2 (induction), Day 1 of Week 4, Day 1 of Week 6, Day 1 of Week 8, and Day 1 of Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 1 will be given BCD-085 every 4 weeks through Week 50. BCD-085 Q2W: In Arm 1, the test drug BCD-085 will be used at a dose of 120 mg given as two SC injections according to the following schedule: once a week for the first 3 weeks (induction treatment) and then once every 2 weeks through Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label patients will receive BCD-085 through week 50. The follow-up will continue through week 54.	BCD-085 Q4W Patients in this arm (85 subjects) will receive 120 mg BCD-085 (two SC injections, 60 mg in 1.0 mL each). Thus, the drug will be administered on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2 (induction), Day 1 of Week 6 and Day 1 of Week 10. For the purpose of blind design, patients will receive a placebo (2 injections) on day 1 of week 4 and week 8. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 2 will continue BCD-085 every 4 weeks through Week 50. BCD-085 Q4W: In Arm 2, and then once every 4 weeks through Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 2 will be given BCD-085 once every 4 weeks through week 50. The follow-up will continue through week 54.	Placebo Patients in this arm (43 subjects) will be given two SC injections of placebo (1.0 mL each) on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2, Day 1 of Week 4, Day 1 of Week 6, Day 1 of Week 8, and Day 1 of Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 3 will receive BCD-085 on Day 1 of Week 12, Day 1 of Week 13, Day 1 of Week 14 (induction), then every 4 weeks through Week 50. Placebo: In Arm 3, patients will be given two SC injections of placebo (1.0 mL each) according to the following schedule: on Day 1 of weeks 0, 1, 2 and then once every 2 weeks through Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 3 will receive BCD-085 at weeks 12, 13, 14 and then once every 4 weeks through week 50. The follow-up will continue through week 54.
Weeks 0-12 STARTED	85	84	44
Weeks 0-12 COMPLETED	85	82	43
Weeks 0-12 NOT COMPLETED	0	2	1
Weeks 12-54 STARTED	85	82	43
Weeks 12-54 COMPLETED	82	78	41
Weeks 12-54 NOT COMPLETED	3	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	BCD-085 Q2W Patients in this arm (85 subjects) will receive 120 mg BCD-085 (two SC injections, 60 mg in 1.0 mL each). Thus, the drug will be administered on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2 (induction), Day 1 of Week 4, Day 1 of Week 6, Day 1 of Week 8, and Day 1 of Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 1 will be given BCD-085 every 4 weeks through Week 50. BCD-085 Q2W: In Arm 1, the test drug BCD-085 will be used at a dose of 120 mg given as two SC injections according to the following schedule: once a week for the first 3 weeks (induction treatment) and then once every 2 weeks through Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label patients will receive BCD-085 through week 50. The follow-up will continue through week 54.	BCD-085 Q4W Patients in this arm (85 subjects) will receive 120 mg BCD-085 (two SC injections, 60 mg in 1.0 mL each). Thus, the drug will be administered on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2 (induction), Day 1 of Week 6 and Day 1 of Week 10. For the purpose of blind design, patients will receive a placebo (2 injections) on day 1 of week 4 and week 8. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 2 will continue BCD-085 every 4 weeks through Week 50. BCD-085 Q4W: In Arm 2, and then once every 4 weeks through Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 2 will be given BCD-085 once every 4 weeks through week 50. The follow-up will continue through week 54.	Placebo Patients in this arm (43 subjects) will be given two SC injections of placebo (1.0 mL each) on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2, Day 1 of Week 4, Day 1 of Week 6, Day 1 of Week 8, and Day 1 of Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 3 will receive BCD-085 on Day 1 of Week 12, Day 1 of Week 13, Day 1 of Week 14 (induction), then every 4 weeks through Week 50. Placebo: In Arm 3, patients will be given two SC injections of placebo (1.0 mL each) according to the following schedule: on Day 1 of weeks 0, 1, 2 and then once every 2 weeks through Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 3 will receive BCD-085 at weeks 12, 13, 14 and then once every 4 weeks through week 50. The follow-up will continue through week 54.
Weeks 0-12 Withdrawal by Subject	0	1	1
Weeks 0-12 Lost to Follow-up	0	1	0
Weeks 12-54 Withdrawal by Subject	0	3	1
Weeks 12-54 Pregnancy	1	0	0
Weeks 12-54 Adverse Event	2	1	1

Baseline Characteristics

An International Multicenter, Randomized, Double-blind, Placebo-Controlled Clinical Study of Efficacy and Safety of Two Dosing Regimens of BCD-085 (JSC BIOCAD, Russia) in Patients With Moderate to Severe Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BCD-085 Q2W n=85 Participants Patients in this arm (85 subjects) will receive 120 mg BCD-085 (two SC injections, 60 mg in 1.0 mL each). Thus, the drug will be administered on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2 (induction), Day 1 of Week 4, Day 1 of Week 6, Day 1 of Week 8, and Day 1 of Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 1 will be given BCD-085 every 4 weeks through Week 50. BCD-085 Q2W: In Arm 1, the test drug BCD-085 will be used at a dose of 120 mg given as two SC injections according to the following schedule: once a week for the first 3 weeks (induction treatment) and then once every 2 weeks through Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label patients will receive BCD-085 through week 50. The follow-up will continue through week 54.	BCD-085 Q4W n=84 Participants Patients in this arm (85 subjects) will receive 120 mg BCD-085 (two SC injections, 60 mg in 1.0 mL each). Thus, the drug will be administered on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2 (induction), Day 1 of Week 6 and Day 1 of Week 10. For the purpose of blind design, patients will receive a placebo (2 injections) on day 1 of week 4 and week 8. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 2 will continue BCD-085 every 4 weeks through Week 50. BCD-085 Q4W: In Arm 2, and then once every 4 weeks through Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 2 will be given BCD-085 once every 4 weeks through week 50. The follow-up will continue through week 54.	Placebo n=44 Participants Patients in this arm (43 subjects) will be given two SC injections of placebo (1.0 mL each) on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2, Day 1 of Week 4, Day 1 of Week 6, Day 1 of Week 8, and Day 1 of Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 3 will receive BCD-085 on Day 1 of Week 12, Day 1 of Week 13, Day 1 of Week 14 (induction), then every 4 weeks through Week 50. Placebo: In Arm 3, patients will be given two SC injections of placebo (1.0 mL each) according to the following schedule: on Day 1 of weeks 0, 1, 2 and then once every 2 weeks through Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 3 will receive BCD-085 at weeks 12, 13, 14 and then once every 4 weeks through week 50. The follow-up will continue through week 54.	Total n=213 Participants Total of all reporting groups
Age, Continuous	42 years n=5 Participants	41.5 years n=7 Participants	39 years n=5 Participants	42 years n=4 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	26 Participants n=7 Participants	9 Participants n=5 Participants	57 Participants n=4 Participants
Sex: Female, Male Male	63 Participants n=5 Participants	58 Participants n=7 Participants	35 Participants n=5 Participants	156 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	85 Participants n=5 Participants	84 Participants n=7 Participants	44 Participants n=5 Participants	213 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Weight	87.3 kg n=5 Participants	89.5 kg n=7 Participants	83.5 kg n=5 Participants	87.3 kg n=4 Participants
Height	178 cm n=5 Participants	176 cm n=7 Participants	175.5 cm n=5 Participants	176 cm n=4 Participants
Body Surface Area Affected by Psoriasis (BSA)	20 percentage of BSA n=5 Participants	22 percentage of BSA n=7 Participants	22.5 percentage of BSA n=5 Participants	22 percentage of BSA n=4 Participants
PASI score	18.4 score n=5 Participants	17.9 score n=7 Participants	19.7 score n=5 Participants	18.6 score n=4 Participants
sPGA score	3 score n=5 Participants	4 score n=7 Participants	4 score n=5 Participants	3 score n=4 Participants

PRIMARY outcome

Timeframe: week 12

Population: ITT-population (all randomized)

Outcome measures

Outcome measures
Measure	BCD-085 Q2W n=85 Participants Patients in this arm (85 subjects) will receive 120 mg BCD-085 (two SC injections, 60 mg in 1.0 mL each). Thus, the drug will be administered on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2 (induction), Day 1 of Week 4, Day 1 of Week 6, Day 1 of Week 8, and Day 1 of Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 1 will be given BCD-085 every 4 weeks through Week 50. BCD-085 Q2W: In Arm 1, the test drug BCD-085 will be used at a dose of 120 mg given as two SC injections according to the following schedule: once a week for the first 3 weeks (induction treatment) and then once every 2 weeks through Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label patients will receive BCD-085 through week 50. The follow-up will continue through week 54.	BCD-085 Q4W n=84 Participants Patients in this arm (85 subjects) will receive 120 mg BCD-085 (two SC injections, 60 mg in 1.0 mL each). Thus, the drug will be administered on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2 (induction), Day 1 of Week 6 and Day 1 of Week 10. For the purpose of blind design, patients will receive a placebo (2 injections) on day 1 of week 4 and week 8. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 2 will continue BCD-085 every 4 weeks through Week 50. BCD-085 Q4W: In Arm 2, and then once every 4 weeks through Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 2 will be given BCD-085 once every 4 weeks through week 50. The follow-up will continue through week 54.	Placebo n=44 Participants Patients in this arm (43 subjects) will be given two SC injections of placebo (1.0 mL each) on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2, Day 1 of Week 4, Day 1 of Week 6, Day 1 of Week 8, and Day 1 of Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 3 will receive BCD-085 on Day 1 of Week 12, Day 1 of Week 13, Day 1 of Week 14 (induction), then every 4 weeks through Week 50. Placebo: In Arm 3, patients will be given two SC injections of placebo (1.0 mL each) according to the following schedule: on Day 1 of weeks 0, 1, 2 and then once every 2 weeks through Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 3 will receive BCD-085 at weeks 12, 13, 14 and then once every 4 weeks through week 50. The follow-up will continue through week 54.
• The Proportion (Number) of Patients in Each Study Arm Who Achieved a PASI 75 at Week 12 of Treatment	66 Participants	70 Participants	0 Participants

Adverse Events

BCD-085 Q2W

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

BCD-085 Q4W

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BCD-085 Q2W n=85 participants at risk Patients in this arm (85 subjects) will receive 120 mg BCD-085 (two SC injections, 60 mg in 1.0 mL each). Thus, the drug will be administered on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2 (induction), Day 1 of Week 4, Day 1 of Week 6, Day 1 of Week 8, and Day 1 of Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 1 will be given BCD-085 every 4 weeks through Week 50. BCD-085 Q2W: In Arm 1, the test drug BCD-085 will be used at a dose of 120 mg given as two SC injections according to the following schedule: once a week for the first 3 weeks (induction treatment) and then once every 2 weeks through Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label patients will receive BCD-085 through week 50. The follow-up will continue through week 54.	BCD-085 Q4W n=84 participants at risk Patients in this arm (85 subjects) will receive 120 mg BCD-085 (two SC injections, 60 mg in 1.0 mL each). Thus, the drug will be administered on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2 (induction), Day 1 of Week 6 and Day 1 of Week 10. For the purpose of blind design, patients will receive a placebo (2 injections) on day 1 of week 4 and week 8. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 2 will continue BCD-085 every 4 weeks through Week 50. BCD-085 Q4W: In Arm 2, and then once every 4 weeks through Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 2 will be given BCD-085 once every 4 weeks through week 50. The follow-up will continue through week 54.	Placebo n=44 participants at risk Patients in this arm (43 subjects) will be given two SC injections of placebo (1.0 mL each) on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2, Day 1 of Week 4, Day 1 of Week 6, Day 1 of Week 8, and Day 1 of Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 3 will receive BCD-085 on Day 1 of Week 12, Day 1 of Week 13, Day 1 of Week 14 (induction), then every 4 weeks through Week 50. Placebo: In Arm 3, patients will be given two SC injections of placebo (1.0 mL each) according to the following schedule: on Day 1 of weeks 0, 1, 2 and then once every 2 weeks through Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 3 will receive BCD-085 at weeks 12, 13, 14 and then once every 4 weeks through week 50. The follow-up will continue through week 54.
Infections and infestations Pneumonia	0.00% 0/85 • Weeks 0-12 The safety analysis included the data from all randomized patients.	1.2% 1/84 • Number of events 1 • Weeks 0-12 The safety analysis included the data from all randomized patients.	0.00% 0/44 • Weeks 0-12 The safety analysis included the data from all randomized patients.

Other adverse events

Additional Information

Nikiforova Aleksandra

BIOCAD

Phone: +7(812) 380 49 33

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	BCD-085 Q2W n=85 participants at risk Patients in this arm (85 subjects) will receive 120 mg BCD-085 (two SC injections, 60 mg in 1.0 mL each). Thus, the drug will be administered on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2 (induction), Day 1 of Week 4, Day 1 of Week 6, Day 1 of Week 8, and Day 1 of Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 1 will be given BCD-085 every 4 weeks through Week 50. BCD-085 Q2W: In Arm 1, the test drug BCD-085 will be used at a dose of 120 mg given as two SC injections according to the following schedule: once a week for the first 3 weeks (induction treatment) and then once every 2 weeks through Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label patients will receive BCD-085 through week 50. The follow-up will continue through week 54.	BCD-085 Q4W n=84 participants at risk Patients in this arm (85 subjects) will receive 120 mg BCD-085 (two SC injections, 60 mg in 1.0 mL each). Thus, the drug will be administered on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2 (induction), Day 1 of Week 6 and Day 1 of Week 10. For the purpose of blind design, patients will receive a placebo (2 injections) on day 1 of week 4 and week 8. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 2 will continue BCD-085 every 4 weeks through Week 50. BCD-085 Q4W: In Arm 2, and then once every 4 weeks through Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 2 will be given BCD-085 once every 4 weeks through week 50. The follow-up will continue through week 54.	Placebo n=44 participants at risk Patients in this arm (43 subjects) will be given two SC injections of placebo (1.0 mL each) on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2, Day 1 of Week 4, Day 1 of Week 6, Day 1 of Week 8, and Day 1 of Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 3 will receive BCD-085 on Day 1 of Week 12, Day 1 of Week 13, Day 1 of Week 14 (induction), then every 4 weeks through Week 50. Placebo: In Arm 3, patients will be given two SC injections of placebo (1.0 mL each) according to the following schedule: on Day 1 of weeks 0, 1, 2 and then once every 2 weeks through Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 3 will receive BCD-085 at weeks 12, 13, 14 and then once every 4 weeks through week 50. The follow-up will continue through week 54.
Vascular disorders Hypertension	0.00% 0/85 • Weeks 0-12 The safety analysis included the data from all randomized patients.	1.2% 1/84 • Number of events 1 • Weeks 0-12 The safety analysis included the data from all randomized patients.	0.00% 0/44 • Weeks 0-12 The safety analysis included the data from all randomized patients.
Vascular disorders Systolic hypertension	1.2% 1/85 • Number of events 1 • Weeks 0-12 The safety analysis included the data from all randomized patients.	0.00% 0/84 • Weeks 0-12 The safety analysis included the data from all randomized patients.	0.00% 0/44 • Weeks 0-12 The safety analysis included the data from all randomized patients.
Vascular disorders Diastolic hypertension	0.00% 0/85 • Weeks 0-12 The safety analysis included the data from all randomized patients.	1.2% 1/84 • Number of events 1 • Weeks 0-12 The safety analysis included the data from all randomized patients.	0.00% 0/44 • Weeks 0-12 The safety analysis included the data from all randomized patients.
Investigations ECG signs of myocardial ischaemia	1.2% 1/85 • Number of events 1 • Weeks 0-12 The safety analysis included the data from all randomized patients.	0.00% 0/84 • Weeks 0-12 The safety analysis included the data from all randomized patients.	0.00% 0/44 • Weeks 0-12 The safety analysis included the data from all randomized patients.
Infections and infestations Upper respiratory tract infection	0.00% 0/85 • Weeks 0-12 The safety analysis included the data from all randomized patients.	0.00% 0/84 • Weeks 0-12 The safety analysis included the data from all randomized patients.	4.5% 2/44 • Number of events 2 • Weeks 0-12 The safety analysis included the data from all randomized patients.
Infections and infestations Tonsillitis	1.2% 1/85 • Number of events 1 • Weeks 0-12 The safety analysis included the data from all randomized patients.	0.00% 0/84 • Weeks 0-12 The safety analysis included the data from all randomized patients.	0.00% 0/44 • Weeks 0-12 The safety analysis included the data from all randomized patients.
Infections and infestations Urinary tract infection	1.2% 1/85 • Number of events 1 • Weeks 0-12 The safety analysis included the data from all randomized patients.	0.00% 0/84 • Weeks 0-12 The safety analysis included the data from all randomized patients.	0.00% 0/44 • Weeks 0-12 The safety analysis included the data from all randomized patients.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/85 • Weeks 0-12 The safety analysis included the data from all randomized patients.	0.00% 0/84 • Weeks 0-12 The safety analysis included the data from all randomized patients.	2.3% 1/44 • Number of events 1 • Weeks 0-12 The safety analysis included the data from all randomized patients.
Skin and subcutaneous tissue disorders Eczema	1.2% 1/85 • Number of events 1 • Weeks 0-12 The safety analysis included the data from all randomized patients.	0.00% 0/84 • Weeks 0-12 The safety analysis included the data from all randomized patients.	0.00% 0/44 • Weeks 0-12 The safety analysis included the data from all randomized patients.
Injury, poisoning and procedural complications Procedural dizziness	1.2% 1/85 • Number of events 1 • Weeks 0-12 The safety analysis included the data from all randomized patients.	1.2% 1/84 • Number of events 1 • Weeks 0-12 The safety analysis included the data from all randomized patients.	0.00% 0/44 • Weeks 0-12 The safety analysis included the data from all randomized patients.
Gastrointestinal disorders Abdominal pain	0.00% 0/85 • Weeks 0-12 The safety analysis included the data from all randomized patients.	1.2% 1/84 • Number of events 1 • Weeks 0-12 The safety analysis included the data from all randomized patients.	0.00% 0/44 • Weeks 0-12 The safety analysis included the data from all randomized patients.
Investigations Haemoglobin increased	1.2% 1/85 • Number of events 1 • Weeks 0-12 The safety analysis included the data from all randomized patients.	0.00% 0/84 • Weeks 0-12 The safety analysis included the data from all randomized patients.	0.00% 0/44 • Weeks 0-12 The safety analysis included the data from all randomized patients.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/85 • Weeks 0-12 The safety analysis included the data from all randomized patients.	1.2% 1/84 • Number of events 1 • Weeks 0-12 The safety analysis included the data from all randomized patients.	0.00% 0/44 • Weeks 0-12 The safety analysis included the data from all randomized patients.
Blood and lymphatic system disorders Leukopenia	1.2% 1/85 • Number of events 1 • Weeks 0-12 The safety analysis included the data from all randomized patients.	2.4% 2/84 • Number of events 2 • Weeks 0-12 The safety analysis included the data from all randomized patients.	0.00% 0/44 • Weeks 0-12 The safety analysis included the data from all randomized patients.
Blood and lymphatic system disorders Neutropenia	3.5% 3/85 • Number of events 3 • Weeks 0-12 The safety analysis included the data from all randomized patients.	1.2% 1/84 • Number of events 1 • Weeks 0-12 The safety analysis included the data from all randomized patients.	0.00% 0/44 • Weeks 0-12 The safety analysis included the data from all randomized patients.
Blood and lymphatic system disorders Lymphocytosis	1.2% 1/85 • Number of events 1 • Weeks 0-12 The safety analysis included the data from all randomized patients.	0.00% 0/84 • Weeks 0-12 The safety analysis included the data from all randomized patients.	2.3% 1/44 • Number of events 1 • Weeks 0-12 The safety analysis included the data from all randomized patients.
Hepatobiliary disorders Hyperbilirubinemia	4.7% 4/85 • Number of events 4 • Weeks 0-12 The safety analysis included the data from all randomized patients.	2.4% 2/84 • Number of events 2 • Weeks 0-12 The safety analysis included the data from all randomized patients.	2.3% 1/44 • Number of events 1 • Weeks 0-12 The safety analysis included the data from all randomized patients.
Investigations Aspartate aminotransferase increased	1.2% 1/85 • Number of events 1 • Weeks 0-12 The safety analysis included the data from all randomized patients.	1.2% 1/84 • Number of events 1 • Weeks 0-12 The safety analysis included the data from all randomized patients.	0.00% 0/44 • Weeks 0-12 The safety analysis included the data from all randomized patients.
Investigations Alanine aminotransferase increased	1.2% 1/85 • Number of events 1 • Weeks 0-12 The safety analysis included the data from all randomized patients.	0.00% 0/84 • Weeks 0-12 The safety analysis included the data from all randomized patients.	0.00% 0/44 • Weeks 0-12 The safety analysis included the data from all randomized patients.
Investigations Blood cholesterol increased	1.2% 1/85 • Number of events 1 • Weeks 0-12 The safety analysis included the data from all randomized patients.	1.2% 1/84 • Number of events 1 • Weeks 0-12 The safety analysis included the data from all randomized patients.	0.00% 0/44 • Weeks 0-12 The safety analysis included the data from all randomized patients.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/85 • Weeks 0-12 The safety analysis included the data from all randomized patients.	3.6% 3/84 • Number of events 3 • Weeks 0-12 The safety analysis included the data from all randomized patients.	0.00% 0/44 • Weeks 0-12 The safety analysis included the data from all randomized patients.
Investigations Blood creatinine increased	0.00% 0/85 • Weeks 0-12 The safety analysis included the data from all randomized patients.	0.00% 0/84 • Weeks 0-12 The safety analysis included the data from all randomized patients.	2.3% 1/44 • Number of events 1 • Weeks 0-12 The safety analysis included the data from all randomized patients.
Renal and urinary disorders Proteinuria	1.2% 1/85 • Number of events 1 • Weeks 0-12 The safety analysis included the data from all randomized patients.	0.00% 0/84 • Weeks 0-12 The safety analysis included the data from all randomized patients.	4.5% 2/44 • Number of events 2 • Weeks 0-12 The safety analysis included the data from all randomized patients.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/85 • Weeks 0-12 The safety analysis included the data from all randomized patients.	0.00% 0/84 • Weeks 0-12 The safety analysis included the data from all randomized patients.	2.3% 1/44 • Number of events 1 • Weeks 0-12 The safety analysis included the data from all randomized patients.