Trial Outcomes & Findings for A Phase 2b Study of the Efficacy, Safety, and Tolerability of M1095 (Sonelokimab) in Subjects With Moderate to Severe Psoriasis (NCT NCT03384745)

Last Updated: 2021-08-03

Results Overview

The primary endpoint is achievement of an IGA score of 0 or 1 at Week 12, with an IGA reduction of at least 2 points from baseline. The percentage of subjects in the Intent to Treat (ITT) Analysis Set with an IGA score of 0 or 1 at Week 12 will be used to compare treatment arms. IGA is the Investigator's Global Assessment of the extent of psoriasis, with 0 = clear of psoriasis, 1 = almost clear, 2 = mild psoriasis, 3 = moderate psoriasis, and 4 = severe psoriasis (the worst assessment on this scale). Higher scores in the IGA indicate a worse outcome.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

313 participants

Primary outcome timeframe

Week 12, as compared to Week 0 (baseline)

Results posted on

2021-08-03

Participant Flow

Subjects were adults aged 18-75 years with stable, moderate to severe plaque type psoriasis for \>6 months prior to randomisation, and who were candidates for systemic biologic therapy.

Participant milestones

Participant milestones
Measure	M1095 30mg M1095, 30 mg, given at Week 0, 2, 4, 8, 12 and every four weeks. Subjects with IGA\>1 at Week 12 were escalated to receive M1095, 120mg M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	M1095 60mg M1095, 60 mg, given at Week 0, 2, 4, 8, 12 and every four weeks. Subjects with IGA\>1 at Week 12 were escalated to receive M1095, 120mg M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	M1095 120mg - Regimen 1 M1095, 120 mg, given at Week 0, 2, 4, 8, 12 and every eight weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	M1095 120mg - Regimen 2 M1095, 120 mg, given at Week 0, 2, 4, 6, 8, 10, 12 and every four weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	Placebo / M1095 120mg Placebo, given at Week 0, 1, 2, 3, 4, 6, 8 and 10, then M1095, 120mg, given at Week 12, 14, 16, and every four weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. Placebo: Placebo contains no active drug.	Secukinumab Secukinumab, 300mg, given at Week 0, 1, 2, 3, 4, 8, 12 and every four weeks. Secukinumab: Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.
Placebo Controlled Induction (W0 - W12) STARTED	52	52	53	51	52	53
Placebo Controlled Induction (W0 - W12) COMPLETED	52	51	50	49	49	51
Placebo Controlled Induction (W0 - W12) NOT COMPLETED	0	1	3	2	3	2
Maintenance/Escalation (W12-W24) STARTED	52	51	50	49	49	51
Maintenance/Escalation (W12-W24) COMPLETED	52	51	49	47	47	51
Maintenance/Escalation (W12-W24) NOT COMPLETED	0	0	1	2	2	0
Response Assess/Dose Hold (W24-W48) STARTED	52	51	49	47	47	51
Response Assess/Dose Hold (W24-W48) COMPLETED	51	48	45	43	46	49
Response Assess/Dose Hold (W24-W48) NOT COMPLETED	1	3	4	4	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	M1095 30mg M1095, 30 mg, given at Week 0, 2, 4, 8, 12 and every four weeks. Subjects with IGA\>1 at Week 12 were escalated to receive M1095, 120mg M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	M1095 60mg M1095, 60 mg, given at Week 0, 2, 4, 8, 12 and every four weeks. Subjects with IGA\>1 at Week 12 were escalated to receive M1095, 120mg M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	M1095 120mg - Regimen 1 M1095, 120 mg, given at Week 0, 2, 4, 8, 12 and every eight weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	M1095 120mg - Regimen 2 M1095, 120 mg, given at Week 0, 2, 4, 6, 8, 10, 12 and every four weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	Placebo / M1095 120mg Placebo, given at Week 0, 1, 2, 3, 4, 6, 8 and 10, then M1095, 120mg, given at Week 12, 14, 16, and every four weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. Placebo: Placebo contains no active drug.	Secukinumab Secukinumab, 300mg, given at Week 0, 1, 2, 3, 4, 8, 12 and every four weeks. Secukinumab: Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.
Placebo Controlled Induction (W0 - W12) Adverse Event	0	0	1	2	0	0
Placebo Controlled Induction (W0 - W12) Withdrawal by Subject	0	0	0	0	3	1
Placebo Controlled Induction (W0 - W12) Lost to Follow-up	0	1	1	0	0	1
Placebo Controlled Induction (W0 - W12) Protocol Violation	0	0	1	0	0	0
Maintenance/Escalation (W12-W24) Adverse Event	0	0	0	1	1	0
Maintenance/Escalation (W12-W24) Withdrawal by Subject	0	0	0	0	1	0
Maintenance/Escalation (W12-W24) Lack of Efficacy	0	0	1	1	0	0
Response Assess/Dose Hold (W24-W48) Adverse Event	1	1	3	0	1	0
Response Assess/Dose Hold (W24-W48) Withdrawal by Subject	0	1	1	2	0	2
Response Assess/Dose Hold (W24-W48) Lost to Follow-up	0	0	0	2	0	0
Response Assess/Dose Hold (W24-W48) Death	0	1	0	0	0	0

Baseline Characteristics

Height was not captured for one subject at baseline.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	M1095 30mg n=52 Participants M1095, 30 mg, given at Week 0, 2, 4, 8, 12 and every four weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	M1095 60mg n=52 Participants M1095, 60 mg, given at Week 0, 2, 4, 8, 12 and every four weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	M1095 120mg - Regimen 1 n=53 Participants M1095, 120 mg, given at Week 0, 2, 4, 8, 12 and every eight weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	M1095 120mg - Regimen 2 n=51 Participants M1095, 120 mg, given at Week 0, 2, 4, 6, 8, 10, 12 and every four weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	Placebo / M1095 120mg n=52 Participants Placebo, given at Week 0, 1, 2, 3, 4, 6, 8 and 10, then M1095, 120mg, given at Week 12, 14, 16, and every four weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. Placebo: Placebo contains no active drug.	Secukinumab n=53 Participants Secukinumab, 300mg, given at Week 0, 1, 2, 3, 4, 8, 12 and every four weeks. Secukinumab: Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.	Total n=313 Participants Total of all reporting groups
Age, Continuous	48.2 years STANDARD_DEVIATION 13.4 • n=52 Participants	46.9 years STANDARD_DEVIATION 12.3 • n=52 Participants	44.1 years STANDARD_DEVIATION 13.1 • n=53 Participants	43.2 years STANDARD_DEVIATION 13.2 • n=51 Participants	45.9 years STANDARD_DEVIATION 12.9 • n=52 Participants	47.5 years STANDARD_DEVIATION 13.8 • n=53 Participants	46.0 years STANDARD_DEVIATION 13.1 • n=313 Participants
Sex: Female, Male Female	36 Participants n=52 Participants	38 Participants n=52 Participants	43 Participants n=53 Participants	34 Participants n=51 Participants	39 Participants n=52 Participants	38 Participants n=53 Participants	228 Participants n=313 Participants
Sex: Female, Male Male	16 Participants n=52 Participants	14 Participants n=52 Participants	10 Participants n=53 Participants	17 Participants n=51 Participants	13 Participants n=52 Participants	15 Participants n=53 Participants	85 Participants n=313 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=52 Participants	3 Participants n=52 Participants	3 Participants n=53 Participants	2 Participants n=51 Participants	1 Participants n=52 Participants	2 Participants n=53 Participants	15 Participants n=313 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	48 Participants n=52 Participants	49 Participants n=52 Participants	50 Participants n=53 Participants	49 Participants n=51 Participants	51 Participants n=52 Participants	51 Participants n=53 Participants	298 Participants n=313 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=52 Participants	0 Participants n=52 Participants	0 Participants n=53 Participants	0 Participants n=51 Participants	0 Participants n=52 Participants	0 Participants n=53 Participants	0 Participants n=313 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=52 Participants	1 Participants n=52 Participants	0 Participants n=53 Participants	0 Participants n=51 Participants	0 Participants n=52 Participants	0 Participants n=53 Participants	1 Participants n=313 Participants
Race (NIH/OMB) Asian	2 Participants n=52 Participants	1 Participants n=52 Participants	8 Participants n=53 Participants	2 Participants n=51 Participants	6 Participants n=52 Participants	3 Participants n=53 Participants	22 Participants n=313 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=52 Participants	0 Participants n=52 Participants	0 Participants n=53 Participants	0 Participants n=51 Participants	0 Participants n=52 Participants	0 Participants n=53 Participants	0 Participants n=313 Participants
Race (NIH/OMB) Black or African American	0 Participants n=52 Participants	1 Participants n=52 Participants	0 Participants n=53 Participants	2 Participants n=51 Participants	2 Participants n=52 Participants	1 Participants n=53 Participants	6 Participants n=313 Participants
Race (NIH/OMB) White	49 Participants n=52 Participants	48 Participants n=52 Participants	45 Participants n=53 Participants	47 Participants n=51 Participants	44 Participants n=52 Participants	49 Participants n=53 Participants	282 Participants n=313 Participants
Race (NIH/OMB) More than one race	0 Participants n=52 Participants	0 Participants n=52 Participants	0 Participants n=53 Participants	0 Participants n=51 Participants	0 Participants n=52 Participants	0 Participants n=53 Participants	0 Participants n=313 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=52 Participants	1 Participants n=52 Participants	0 Participants n=53 Participants	0 Participants n=51 Participants	0 Participants n=52 Participants	0 Participants n=53 Participants	2 Participants n=313 Participants
Region of Enrollment Canada	7 participants n=52 Participants	9 participants n=52 Participants	11 participants n=53 Participants	9 participants n=51 Participants	12 participants n=52 Participants	11 participants n=53 Participants	59 participants n=313 Participants
Region of Enrollment Hungary	6 participants n=52 Participants	8 participants n=52 Participants	6 participants n=53 Participants	4 participants n=51 Participants	5 participants n=52 Participants	4 participants n=53 Participants	33 participants n=313 Participants
Region of Enrollment United States	10 participants n=52 Participants	7 participants n=52 Participants	6 participants n=53 Participants	5 participants n=51 Participants	3 participants n=52 Participants	5 participants n=53 Participants	36 participants n=313 Participants
Region of Enrollment Czechia	13 participants n=52 Participants	14 participants n=52 Participants	13 participants n=53 Participants	8 participants n=51 Participants	16 participants n=52 Participants	16 participants n=53 Participants	80 participants n=313 Participants
Region of Enrollment Poland	8 participants n=52 Participants	8 participants n=52 Participants	7 participants n=53 Participants	13 participants n=51 Participants	5 participants n=52 Participants	10 participants n=53 Participants	51 participants n=313 Participants
Region of Enrollment Bulgaria	7 participants n=52 Participants	4 participants n=52 Participants	8 participants n=53 Participants	10 participants n=51 Participants	9 participants n=52 Participants	5 participants n=53 Participants	43 participants n=313 Participants
Region of Enrollment Germany	1 participants n=52 Participants	2 participants n=52 Participants	2 participants n=53 Participants	2 participants n=51 Participants	2 participants n=52 Participants	2 participants n=53 Participants	11 participants n=313 Participants
Height (cm)	173 centimetres STANDARD_DEVIATION 10.4 • n=52 Participants • Height was not captured for one subject at baseline.	173 centimetres STANDARD_DEVIATION 9.60 • n=52 Participants • Height was not captured for one subject at baseline.	174 centimetres STANDARD_DEVIATION 9.89 • n=53 Participants • Height was not captured for one subject at baseline.	173 centimetres STANDARD_DEVIATION 11.2 • n=50 Participants • Height was not captured for one subject at baseline.	173 centimetres STANDARD_DEVIATION 10.1 • n=52 Participants • Height was not captured for one subject at baseline.	172 centimetres STANDARD_DEVIATION 9.98 • n=53 Participants • Height was not captured for one subject at baseline.	173 centimetres STANDARD_DEVIATION 10.2 • n=312 Participants • Height was not captured for one subject at baseline.
Weight at baseline (kg)	92.0 kilograms STANDARD_DEVIATION 19.0 • n=52 Participants	91.5 kilograms STANDARD_DEVIATION 20.6 • n=52 Participants	89.0 kilograms STANDARD_DEVIATION 18.3 • n=53 Participants	93.0 kilograms STANDARD_DEVIATION 22.6 • n=51 Participants	91.3 kilograms STANDARD_DEVIATION 24.1 • n=52 Participants	90.3 kilograms STANDARD_DEVIATION 22.4 • n=53 Participants	91.2 kilograms STANDARD_DEVIATION 21.1 • n=313 Participants
Prior biological use (actual) Yes	9 Participants n=52 Participants	10 Participants n=52 Participants	9 Participants n=53 Participants	7 Participants n=51 Participants	8 Participants n=52 Participants	7 Participants n=53 Participants	50 Participants n=313 Participants
Prior biological use (actual) No	43 Participants n=52 Participants	42 Participants n=52 Participants	44 Participants n=53 Participants	44 Participants n=51 Participants	44 Participants n=52 Participants	46 Participants n=53 Participants	263 Participants n=313 Participants
Duration of psoriasis (years)	20.0 years STANDARD_DEVIATION 13.6 • n=52 Participants	19.7 years STANDARD_DEVIATION 12.8 • n=52 Participants	15.8 years STANDARD_DEVIATION 12.9 • n=53 Participants	18.0 years STANDARD_DEVIATION 11.7 • n=51 Participants	16.3 years STANDARD_DEVIATION 12.1 • n=52 Participants	20.2 years STANDARD_DEVIATION 13.6 • n=53 Participants	18.3 years STANDARD_DEVIATION 12.8 • n=313 Participants
Presence of psoriatic arthritis Yes	2 Participants n=52 Participants	5 Participants n=52 Participants	7 Participants n=53 Participants	6 Participants n=51 Participants	3 Participants n=52 Participants	2 Participants n=53 Participants	25 Participants n=313 Participants
Presence of psoriatic arthritis No	50 Participants n=52 Participants	47 Participants n=52 Participants	46 Participants n=53 Participants	45 Participants n=51 Participants	49 Participants n=52 Participants	51 Participants n=53 Participants	288 Participants n=313 Participants
Investigator's Global Assessment (IGA) at baseline 3	38 Participants n=52 Participants	37 Participants n=52 Participants	39 Participants n=53 Participants	40 Participants n=51 Participants	41 Participants n=52 Participants	38 Participants n=53 Participants	233 Participants n=313 Participants
Investigator's Global Assessment (IGA) at baseline 4	14 Participants n=52 Participants	15 Participants n=52 Participants	14 Participants n=53 Participants	11 Participants n=51 Participants	11 Participants n=52 Participants	15 Participants n=53 Participants	80 Participants n=313 Participants
Psoriasis Area and Severity Index (PASI) at baseline	20.3 units on a scale STANDARD_DEVIATION 7.91 • n=52 Participants	20.7 units on a scale STANDARD_DEVIATION 9.34 • n=52 Participants	21.1 units on a scale STANDARD_DEVIATION 8.38 • n=53 Participants	20.6 units on a scale STANDARD_DEVIATION 7.15 • n=51 Participants	20.5 units on a scale STANDARD_DEVIATION 6.89 • n=52 Participants	21.7 units on a scale STANDARD_DEVIATION 8.80 • n=53 Participants	20.8 units on a scale STANDARD_DEVIATION 8.08 • n=313 Participants
Percentage of total Body Surface Area (BSA) affected at baseline	26.0 % of body surface area affected STANDARD_DEVIATION 15.7 • n=52 Participants	24.8 % of body surface area affected STANDARD_DEVIATION 15.6 • n=52 Participants	25.3 % of body surface area affected STANDARD_DEVIATION 14.8 • n=53 Participants	26.4 % of body surface area affected STANDARD_DEVIATION 12.8 • n=51 Participants	26.2 % of body surface area affected STANDARD_DEVIATION 16.7 • n=52 Participants	28.1 % of body surface area affected STANDARD_DEVIATION 16.1 • n=53 Participants	26.1 % of body surface area affected STANDARD_DEVIATION 15.2 • n=313 Participants

PRIMARY outcome

Timeframe: Week 12, as compared to Week 0 (baseline)

Outcome measures

Outcome measures
Measure	M1095 120mg - Normal Load Group n=53 Participants M1095, 120 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	Secukinumab n=53 Participants Secukinumab, 300mg, given at Week 0, 1, 2, 3, 4, and 8 weeks. Secukinumab: Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.	M1095 30mg n=52 Participants M1095, 30 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	M1095 60mg n=52 Participants M1095, 60 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	M1095 120mg - Regimen 2 n=51 Participants M1095, 120 mg, given at Week 0, 2, 4, 6, 8, and 10 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	Placebo / M1095 120mg n=52 Participants Placebo, given at Week 0, 1, 2, 3, 4, 6, 8 and 10 weeks. Placebo: Placebo contains no active drug.
Number of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1	41 Participants	41 Participants	25 Participants	44 Participants	45 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 12, as compared to Week 0 (baseline)

PASI 100, i.e. a subject's psoriasis has completely cleared at Week 12, compared to baseline.

Outcome measures

Outcome measures
Measure	M1095 120mg - Normal Load Group n=53 Participants M1095, 120 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	Secukinumab n=53 Participants Secukinumab, 300mg, given at Week 0, 1, 2, 3, 4, and 8 weeks. Secukinumab: Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.	M1095 30mg n=52 Participants M1095, 30 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	M1095 60mg n=52 Participants M1095, 60 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	M1095 120mg - Regimen 2 n=51 Participants M1095, 120 mg, given at Week 0, 2, 4, 6, 8, and 10 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	Placebo / M1095 120mg n=52 Participants Placebo, given at Week 0, 1, 2, 3, 4, 6, 8 and 10 weeks. Placebo: Placebo contains no active drug.
Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 100% (i.e. Clear of Psoriasis)	20 Participants	15 Participants	9 Participants	13 Participants	17 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 12, as compared to baseline

PASI 90, i.e. a subject's psoriasis has cleared by 90% at Week 12, compared to baseline

Outcome measures

Outcome measures
Measure	M1095 120mg - Normal Load Group n=53 Participants M1095, 120 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	Secukinumab n=53 Participants Secukinumab, 300mg, given at Week 0, 1, 2, 3, 4, and 8 weeks. Secukinumab: Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.	M1095 30mg n=52 Participants M1095, 30 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	M1095 60mg n=52 Participants M1095, 60 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	M1095 120mg - Regimen 2 n=51 Participants M1095, 120 mg, given at Week 0, 2, 4, 6, 8, and 10 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	Placebo / M1095 120mg n=52 Participants Placebo, given at Week 0, 1, 2, 3, 4, 6, 8 and 10 weeks. Placebo: Placebo contains no active drug.
Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 90% (i.e. a 90% Improvement in Psoriasis)	37 Participants	34 Participants	19 Participants	34 Participants	39 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 12, as compared to Week 0 (baseline)

PASI 75, i.e. a subject's psoriasis has cleared by 75% at Week 12, compared to baseline

Outcome measures

Outcome measures
Measure	M1095 120mg - Normal Load Group n=53 Participants M1095, 120 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	Secukinumab n=53 Participants Secukinumab, 300mg, given at Week 0, 1, 2, 3, 4, and 8 weeks. Secukinumab: Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.	M1095 30mg n=52 Participants M1095, 30 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	M1095 60mg n=52 Participants M1095, 60 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	M1095 120mg - Regimen 2 n=51 Participants M1095, 120 mg, given at Week 0, 2, 4, 6, 8, and 10 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	Placebo / M1095 120mg n=52 Participants Placebo, given at Week 0, 1, 2, 3, 4, 6, 8 and 10 weeks. Placebo: Placebo contains no active drug.
Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 75% (i.e. a 75% Improvement in Psoriasis)	45 Participants	48 Participants	34 Participants	46 Participants	46 Participants	0 Participants

Adverse Events

Placebo (Week 0 to Week 12)

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

M1095 30mg (Week 0 to Week 12)

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

M1095 60 mg (Week 0 to Week 12)

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

M1095 120mg - Normal Load Group (Week 0 to Week 12)

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

M1095 120mg - Augmented Load Group (Week 0 to Week 12)

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Secukinumab (Week 0 to Week 12)

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

M1095 - All Participants (Week 0 to Week 12 )

Serious events: 5 serious events

Other events: 62 other events

Deaths: 0 deaths

M1095 - All Participants (Week 12 to Week 52)

Serious events: 12 serious events

Other events: 57 other events

Deaths: 1 deaths

Secukinumab (Week 12 to Week 52)

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo (Week 0 to Week 12) n=52 participants at risk Placebo given at Weeks 0, 2, 4 and 8. Placebo: Placebo contains no active drug.	M1095 30mg (Week 0 to Week 12) n=52 participants at risk M1095, 30mg, given at Weeks 0, 2, 4 and 8. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	M1095 60 mg (Week 0 to Week 12) n=52 participants at risk M1095, 60mg, given at Weeks 0, 2, 4 and 8. M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	M1095 120mg - Normal Load Group (Week 0 to Week 12) n=53 participants at risk M1095, 120 mg, given at Weeks 0, 2, 4 and 8. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	M1095 120mg - Augmented Load Group (Week 0 to Week 12) n=51 participants at risk M1095, 120 mg, given at Weeks 0, 2, 4, 6, 8 and 10. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	Secukinumab (Week 0 to Week 12) n=53 participants at risk Secukinumab, 300mg, given at Weeks 0, 1, 2, 3, 4 and 8. Secukinumab: Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.	M1095 - All Participants (Week 0 to Week 12 ) n=208 participants at risk All participants receiving M1095, 30mg, 60mg, or 120mg from Week 0 to Week 12. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	M1095 - All Participants (Week 12 to Week 52) n=251 participants at risk All participants receiving M1095, 30mg, 60mg, or 120mg from Week 12 to Week 44, including subjects randomised to placebo, who received M1095 120mg from Weeks 12, 14, 16, 20, etc. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	Secukinumab (Week 12 to Week 52) n=51 participants at risk Secukinumab, 300mg, given at Weeks 12, 16, 20 and every 4 weeks to week 44) Secukinumab: Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.
Vascular disorders Deep vein thrombosis	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/208 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.40% 1/251 • Number of events 1 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	1.9% 1/52 • Number of events 1 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.48% 1/208 • Number of events 1 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/251 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	1.9% 1/52 • Number of events 1 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.48% 1/208 • Number of events 1 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/251 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/208 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.40% 1/251 • Number of events 1 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.
Cardiac disorders Atrial fibrillation	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/208 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.80% 2/251 • Number of events 2 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.
Cardiac disorders Cardiopulmonary failure	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/208 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.40% 1/251 • Number of events 1 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.
Cardiac disorders Myocardial infarction	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/208 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.40% 1/251 • Number of events 1 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	1.9% 1/52 • Number of events 1 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.48% 1/208 • Number of events 1 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/251 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.
Nervous system disorders Neuroglycopenia	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/208 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.40% 1/251 • Number of events 1 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.
Eye disorders Optic ischaemic neuropathy	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/208 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.40% 1/251 • Number of events 1 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.
Gastrointestinal disorders Salivary gland calculus	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/208 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.40% 1/251 • Number of events 1 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.
Renal and urinary disorders Acute kidney injury	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	2.0% 1/51 • Number of events 1 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.48% 1/208 • Number of events 1 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/251 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.
Renal and urinary disorders Renal colic	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	1.9% 1/53 • Number of events 1 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.48% 1/208 • Number of events 1 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/251 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.
Infections and infestations Erysipelas	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/208 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.40% 1/251 • Number of events 1 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.
Infections and infestations Infectious pleural effusion	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/208 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/251 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	2.0% 1/51 • Number of events 1 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.
Infections and infestations Oesophageal candidiasis	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/208 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/251 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	2.0% 1/51 • Number of events 1 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.
Infections and infestations Oropharyngeal candidiasis	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/208 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.40% 1/251 • Number of events 1 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.
Infections and infestations Pneumonia	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	2.0% 1/51 • Number of events 1 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.48% 1/208 • Number of events 1 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/251 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	2.0% 1/51 • Number of events 1 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.
Infections and infestations Pyelonephritis acute	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/208 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.40% 1/251 • Number of events 1 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/208 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.40% 1/251 • Number of events 1 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.
Vascular disorders Hypertension	1.9% 1/52 • Number of events 1 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/208 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/251 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.

Other adverse events

Other adverse events
Measure	Placebo (Week 0 to Week 12) n=52 participants at risk Placebo given at Weeks 0, 2, 4 and 8. Placebo: Placebo contains no active drug.	M1095 30mg (Week 0 to Week 12) n=52 participants at risk M1095, 30mg, given at Weeks 0, 2, 4 and 8. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	M1095 60 mg (Week 0 to Week 12) n=52 participants at risk M1095, 60mg, given at Weeks 0, 2, 4 and 8. M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	M1095 120mg - Normal Load Group (Week 0 to Week 12) n=53 participants at risk M1095, 120 mg, given at Weeks 0, 2, 4 and 8. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	M1095 120mg - Augmented Load Group (Week 0 to Week 12) n=51 participants at risk M1095, 120 mg, given at Weeks 0, 2, 4, 6, 8 and 10. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	Secukinumab (Week 0 to Week 12) n=53 participants at risk Secukinumab, 300mg, given at Weeks 0, 1, 2, 3, 4 and 8. Secukinumab: Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.	M1095 - All Participants (Week 0 to Week 12 ) n=208 participants at risk All participants receiving M1095, 30mg, 60mg, or 120mg from Week 0 to Week 12. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	M1095 - All Participants (Week 12 to Week 52) n=251 participants at risk All participants receiving M1095, 30mg, 60mg, or 120mg from Week 12 to Week 44, including subjects randomised to placebo, who received M1095 120mg from Weeks 12, 14, 16, 20, etc. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	Secukinumab (Week 12 to Week 52) n=51 participants at risk Secukinumab, 300mg, given at Weeks 12, 16, 20 and every 4 weeks to week 44) Secukinumab: Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.
Infections and infestations Nasopharyngitis	7.7% 4/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	7.7% 4/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	21.2% 11/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	17.0% 9/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	7.8% 4/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	11.3% 6/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	13.5% 28/208 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	10.4% 26/251 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	13.7% 7/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.
Infections and infestations Upper respiratory tract infection	1.9% 1/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	1.9% 1/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	5.8% 3/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	5.7% 3/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	3.9% 2/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	5.7% 3/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	4.3% 9/208 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	4.8% 12/251 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	5.9% 3/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.
Skin and subcutaneous tissue disorders Pruritus	3.8% 2/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	5.8% 3/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	7.7% 4/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	5.7% 3/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	7.8% 4/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	1.9% 1/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	6.7% 14/208 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	2.4% 6/251 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	2.0% 1/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.
Infections and infestations Oral candidiasis	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	1.9% 1/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	3.8% 2/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	5.9% 3/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	2.9% 6/208 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	5.2% 13/251 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.
Nervous system disorders Headache	1.9% 1/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	5.8% 3/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	5.7% 3/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	2.0% 1/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	5.7% 3/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	3.4% 7/208 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	1.2% 3/251 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	2.0% 1/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.
Musculoskeletal and connective tissue disorders Arthralgia	1.9% 1/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	5.8% 3/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	1.9% 1/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	3.9% 2/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	2.9% 6/208 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	2.0% 5/251 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	3.9% 2/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.
Vascular disorders Hypertension	3.8% 2/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	5.8% 3/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	1.9% 1/52 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	0.00% 0/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	3.9% 2/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	1.9% 1/53 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	2.9% 6/208 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	2.0% 5/251 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.	3.9% 2/51 • Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52). Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.

Additional Information

Chief Medical Officer

Avillion LLP

Phone: +44 (0)203 764 9530

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60