Trial Outcomes & Findings for Dupilumab As An Adjunct For Subcutaneous Grass Immunotherapy (NCT NCT03558997)

NCT ID: NCT03558997

Last Updated: 2020-05-28

Results Overview

TNSS was participant-reported composite symptom assessment of 4 symptoms (rhinorrhea, nasal congestion, nasal itching \& sneezing), each scored on a scale from 0 to 3 where 0 = none, 3 = severe. TNSS total score was calculated as the sum of the response for all 4 individual nasal symptom scores and ranged from 0 to 12, where higher score indicated more severe symptoms. AUC of TNSS/component from time of the first observation to time of the last observation (AUC \[0-1 hr\]) was calculated by using the trapezoid rule. Data was reported for Dupilumab + SCIT and placebo matched to Dupilumab + SCIT monotherapy group in this outcome measure.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 103 participants
• Primary outcome timeframe: Baseline, Week 17
• Results posted on: 2020-05-28

Participant Flow

A total of 214 participants were screened for study eligibility at 17 study sites in United States and Canada, of whom 103 were randomized to receive the study treatment. Screen failure was mostly due to inclusion criteria not met/exclusion criteria met.

Participants who met the eligibility criteria were randomized in 1:1:1:1 ratio to 1 of 4 treatment groups: Placebo, Dupilumab, Subcutaneous immunotherapy (SCIT) and Dupilumab + SCIT.

Participant milestones

Measure	Placebo Participants received placebo matched to Dupilumab and placebo matched to Timothy grass subcutaneous immunotherapy (SCIT) every 2 weeks (Q2W) for 16 weeks. Both placebo doses were administered with a gap of 1 to 7 days.	Dupilumab Participants received placebo matched to SCIT and subcutaneous (SC) injections of Dupilumab at a loading dose of 600 milligrams (mg) on Day 1, followed by a 300 mg for Q2W for 16 weeks. Both placebo matched to SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.	SCIT Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 to 7 days.	Dupilumab + SCIT Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.
Overall Study STARTED	25	26	26	26
Overall Study COMPLETED	24	24	18	24
Overall Study NOT COMPLETED	1	2	8	2

Reasons for withdrawal

Measure	Placebo Participants received placebo matched to Dupilumab and placebo matched to Timothy grass subcutaneous immunotherapy (SCIT) every 2 weeks (Q2W) for 16 weeks. Both placebo doses were administered with a gap of 1 to 7 days.	Dupilumab Participants received placebo matched to SCIT and subcutaneous (SC) injections of Dupilumab at a loading dose of 600 milligrams (mg) on Day 1, followed by a 300 mg for Q2W for 16 weeks. Both placebo matched to SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.	SCIT Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 to 7 days.	Dupilumab + SCIT Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.
Overall Study Adverse Event	0	2	5	1
Overall Study Physician Decision	0	0	1	0
Overall Study Withdrawal by Subject	1	0	1	1
Overall Study Lost to Follow-up	0	0	1	0

Baseline Characteristics

Dupilumab As An Adjunct For Subcutaneous Grass Immunotherapy

Baseline characteristics by cohort

Measure	Placebo n=25 Participants Participants received placebo matched to Dupilumab and placebo matched to Timothy grass subcutaneous immunotherapy (SCIT) every 2 weeks (Q2W) for 16 weeks. Both placebo doses were administered with a gap of 1 to 7 days.	Dupilumab n=26 Participants Participants received placebo matched to SCIT and subcutaneous (SC) injections of Dupilumab at a loading dose of 600 milligrams (mg) on Day 1, followed by a 300 mg for Q2W for 16 weeks. Both placebo matched to SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.	SCIT n=26 Participants Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 to 7 days.	Dupilumab + SCIT n=26 Participants Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.	Total n=103 Participants Total of all reporting groups
Age, Continuous	34.6 Years STANDARD_DEVIATION 11.05 • n=5 Participants	40.3 Years STANDARD_DEVIATION 11.19 • n=7 Participants	37.8 Years STANDARD_DEVIATION 11.25 • n=5 Participants	33.0 Years STANDARD_DEVIATION 10.58 • n=4 Participants	36.5 Years STANDARD_DEVIATION 11.22 • n=21 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	16 Participants n=7 Participants	14 Participants n=5 Participants	10 Participants n=4 Participants	50 Participants n=21 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	10 Participants n=7 Participants	12 Participants n=5 Participants	16 Participants n=4 Participants	53 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	1 Participants n=4 Participants	11 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants	24 Participants n=7 Participants	21 Participants n=5 Participants	25 Participants n=4 Participants	91 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	12 Participants n=21 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	18 Participants n=7 Participants	17 Participants n=5 Participants	21 Participants n=4 Participants	76 Participants n=21 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Total nasal symptom score (TNSS) Area under Curve (AUC) [0-1 hour (hr)] at Baseline	5.34 Score on a Scale*hour STANDARD_DEVIATION 2.175 • n=5 Participants	5.03 Score on a Scale*hour STANDARD_DEVIATION 2.193 • n=7 Participants	4.66 Score on a Scale*hour STANDARD_DEVIATION 1.987 • n=5 Participants	4.69 Score on a Scale*hour STANDARD_DEVIATION 1.720 • n=4 Participants	4.93 Score on a Scale*hour STANDARD_DEVIATION 2.015 • n=21 Participants
Timothy Grass Pollen IgG4	0.080 Miligram per Liter (mg/L) n=5 Participants	0.080 Miligram per Liter (mg/L) n=7 Participants	0.080 Miligram per Liter (mg/L) n=5 Participants	0.080 Miligram per Liter (mg/L) n=4 Participants	0.080 Miligram per Liter (mg/L) n=21 Participants
Timothy Grass Specific Immunoglobulin E (sIgE)	9.640 Kilo Unit per Liter (kU/L) n=5 Participants	4.810 Kilo Unit per Liter (kU/L) n=7 Participants	10.300 Kilo Unit per Liter (kU/L) n=5 Participants	11.250 Kilo Unit per Liter (kU/L) n=4 Participants	9.180 Kilo Unit per Liter (kU/L) n=21 Participants
Log Transformed Timothy Grass Pollen IgG4 vs sIgE ratio	-1.970 Ratio n=5 Participants	-1.515 Ratio n=7 Participants	-1.860 Ratio n=5 Participants	-1.975 Ratio n=4 Participants	-1.840 Ratio n=21 Participants

PRIMARY outcome

Timeframe: Baseline, Week 17

Population: The full analysis set (FAS) included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized).

TNSS was participant-reported composite symptom assessment of 4 symptoms (rhinorrhea, nasal congestion, nasal itching & sneezing), each scored on a scale from 0 to 3 where 0 = none, 3 = severe. TNSS total score was calculated as the sum of the response for all 4 individual nasal symptom scores and ranged from 0 to 12, where higher score indicated more severe symptoms. AUC of TNSS/component from time of the first observation to time of the last observation (AUC [0-1 hr]) was calculated by using the trapezoid rule. Data was reported for Dupilumab + SCIT and placebo matched to Dupilumab + SCIT monotherapy group in this outcome measure.

Outcome measures

Measure	SCIT n=26 Participants Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 to 7 days.	Dupilumab + SCIT n=26 Participants Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.	SCIT Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 to 7 days.	Dupilumab + SCIT Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.
Percent Change From Baseline in Total Nasal Symptom Score (TNSS) Area Under Curve (AUC) (0-1 Hour (hr) Post Peak TNSS) in Response to Post Nasal Allergen Challenge (NAC) at Week 17	-56.76 Percent Change Standard Error 9.687	-52.03 Percent Change Standard Error 8.462	—	—

SECONDARY outcome

Timeframe: Baseline, Week 17

Population: FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized).

TNSS was participant-reported composite symptom assessment of 4 symptoms (rhinorrhea, nasal congestion, nasal itching & sneezing) each scored on a scale from 0 to 3 where 0 = none, 3 = severe. TNSS total score was calculated as the sum of the response for all 4 individual nasal symptom scores and ranged from 0 to 12, where higher score indicated more severe symptoms. AUC of TNSS/component from time of the first observation to time of the last observation (AUC [0-1 hr]) was calculated by using the trapezoid rule. Data was reported for Dupilumab + SCIT and placebo matched to Dupilumab + SCIT monotherapy group in this outcome measure.

Outcome measures

Measure	SCIT n=26 Participants Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 to 7 days.	Dupilumab + SCIT n=26 Participants Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.	SCIT Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 to 7 days.	Dupilumab + SCIT Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.
Change From Baseline in Total Nasal Symptom Score (TNSS) Area Under Curve (AUC) Post Nasal Allergen Challenge (NAC) Over the First Hour After the Challenge (0-1 Hour (hr) Post Peak TNSS) at Week 17 in SCIT vs. Dupilumab + SCIT	-3.07 Score on a Scale*hour Standard Error 0.361	-2.77 Score on a Scale*hour Standard Error 0.321	—	—

SECONDARY outcome

Timeframe: Baseline, Week 17

Population: FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized).

TNSS was participant-reported composite symptom assessment of 4 symptoms (rhinorrhea, nasal congestion, nasal itching & sneezing) each scored on a scale from 0 to 3 where 0 = none, 3 = severe. TNSS total score was calculated as the sum of the response for all 4 individual nasal symptom scores and ranged from 0 to 12, where higher score indicated more severe symptoms. AUC of TNSS/component from time of the first observation to time of the last observation (AUC [0-1 hr]) was calculated by using the trapezoid rule. Data was reported for Dupilumab + placebo matched to SCIT and placebo matched to dupilumab + placebo matched to SCIT group in this outcome measure.

Outcome measures

Measure	SCIT n=25 Participants Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 to 7 days.	Dupilumab + SCIT n=26 Participants Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.	SCIT Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 to 7 days.	Dupilumab + SCIT Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.
Change From Baseline in Total Nasal Symptom Score (TNSS) Area Under Curve (AUC) Post Nasal Allergen Challenge (NAC) Over the First Hour After the Challenge (0-1 Hour (hr) Post Peak TNSS) at Week 17 in Placebo vs. Dupilumab	-1.85 Score on a Scale*hour Standard Error 0.323	-1.83 Score on a Scale*hour Standard Error 0.329	—	—

SECONDARY outcome

Timeframe: Baseline, Week 17

Population: FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized).

TNSS was participant-reported composite symptom assessment of 4 symptoms (rhinorrhea, nasal congestion, nasal itching & sneezing) each scored on a scale from 0 to 3 where 0 = none, 3 = severe. TNSS total score was calculated as the sum of the response for all 4 individual nasal symptom scores and ranged from 0 to 12, where higher score indicated more severe symptoms. AUC of TNSS/component from time of the first observation to time of the last observation (AUC [0-1 hr]) was calculated by using the trapezoid rule. Data was reported for Dupilumab + placebo matched to SCIT and placebo matched to dupilumab + placebo matched to SCIT.

Outcome measures

Measure	SCIT n=25 Participants Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 to 7 days.	Dupilumab + SCIT n=26 Participants Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.	SCIT Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 to 7 days.	Dupilumab + SCIT Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.
Percent Change From Baseline in Total Nasal Symptom Score (TNSS) Area Under Curve (AUC) Post Nasal Allergen Challenge (NAC) Over the First Hour of the Challenge (0-1 Hour (hr) Post Peak TNSS) at Week 17	-28.82 Percent Change Standard Error 8.427	-21.57 Percent Change Standard Error 8.415	—	—

SECONDARY outcome

Timeframe: Baseline, Week 17

Population: FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized).

TNSS was participant-reported composite symptom assessment of 4 symptoms (rhinorrhea, nasal congestion, nasal itching & sneezing) each scored on a scale from 0 to 3 where 0 = none, 3 = severe. TNSS total score was calculated as the sum of responses for all 4 individual nasal symptom scores and ranged from 0 to 12, where higher score indicated more severe symptoms. AUC of TNSS/component from time of the first observation to time of the last observation (AUC [0-1 hr]) was calculated by using the trapezoid rule. Data was reported for Dupilumab + SCIT and Dupilumab + placebo matched to SCIT group in this outcome measure.

Outcome measures

Measure	SCIT n=26 Participants Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 to 7 days.	Dupilumab + SCIT n=26 Participants Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.	SCIT Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 to 7 days.	Dupilumab + SCIT Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.
Change From Baseline in TNSS Area Under Curve (AUC) Post Nasal Allergen Challenge (NAC) Over the First Hour of the Challenge (0-1 Hour (hr) Post Peak TNSS) at Week 17	-1.83 Score on a Scale*hour Standard Error 0.329	-2.77 Score on a Scale*hour Standard Error 0.321	—	—

SECONDARY outcome

Timeframe: Baseline, Week 17

Population: FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized).

TNSS was participant-reported composite symptom assessment of 4 symptoms (rhinorrhea, nasal congestion, nasal itching & sneezing) each scored on a scale from 0 to 3 where 0 = none, 3 = severe. TNSS total score was calculated as the sum of the response for all 4 individual nasal symptom scores and ranged from 0 to 12, where higher score indicated more severe symptoms. AUC of TNSS/component from time of the first observation to time of the last observation (AUC [0-1 hr]) was calculated by using the trapezoid rule. Data was reported for Dupilumab + SCIT and Dupilumab + placebo matched to SCIT group in this outcome measure.

Outcome measures

Measure	SCIT n=26 Participants Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 to 7 days.	Dupilumab + SCIT n=26 Participants Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.	SCIT Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 to 7 days.	Dupilumab + SCIT Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.
Percent Change From Baseline in TNSS Area Under Curve (AUC) Post Nasal Allergen Challenge (NAC) Over the First Hour of the Challenge (0-1 Hour (hr) Post Peak TNSS) at Week 17	-21.57 Percent Change Standard Error 8.415	-52.03 Percent Change Standard Error 8.462	—	—

SECONDARY outcome

Timeframe: Baseline, Week 17

Population: FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized).

Measurement of Timothy Grass specific IgG4 was performed in serum or plasma to determine effects on biomarkers of relevant physiological and pathogenic processes. Data was reported for Dupilumab + SCIT and placebo matched to Dupilumab + SCIT monotherapy group in this outcome measure. Missing values were imputed by Last Observation Carried Forward (LOCF) method for visits between post-baseline to Week 17.

Outcome measures

Measure	SCIT n=26 Participants Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 to 7 days.	Dupilumab + SCIT n=26 Participants Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.	SCIT Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 to 7 days.	Dupilumab + SCIT Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.
Change From Baseline in Serum Timothy Grass Specific Immunoglobulin G4 (sIgG4) to Week 17	1.705 Milligram per Liter (mg/L) Interval 0.52 to 6.09	3.550 Milligram per Liter (mg/L) Interval 0.63 to 8.25	—	—

SECONDARY outcome

Timeframe: Baseline, Week 17

Population: FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized).

Measurement of Timothy Grass specific IgG4 was performed in serum or plasma to determine effects on biomarkers of relevant physiological and pathogenic processes. Data was for Dupilumab + SCIT and placebo matched to Dupilumab + SCIT monotherapy group in this outcome measure. Missing value was imputed by LOCF method for visits between post-baseline to Week 17.

Outcome measures

Measure	SCIT n=26 Participants Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 to 7 days.	Dupilumab + SCIT n=26 Participants Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.	SCIT Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 to 7 days.	Dupilumab + SCIT Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.
Percent Change From Baseline in Serum Timothy Grass Specific Immunoglobulin G4 (sIgG4) to Week 17	1444.49 Percent Change Interval 650.0 to 2650.0	1896.25 Percent Change Interval 700.0 to 5050.0	—	—

SECONDARY outcome

Timeframe: Baseline, Week 17

Population: FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized).

Measurement of Timothy Grass specific sIgE was performed in serum or plasma to determine effects on biomarkers of relevant physiological and pathogenic processes. Data was reported for Dupilumab + SCIT and placebo matched to Dupilumab + SCIT monotherapy group in this outcome measure. Missing value was imputed by LOCF method for visits between post-baseline to Week 17.

Outcome measures

Measure	SCIT n=26 Participants Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 to 7 days.	Dupilumab + SCIT n=26 Participants Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.	SCIT Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 to 7 days.	Dupilumab + SCIT Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.
Change From Baseline in Serum Timothy Grass Specific Immunoglobulin E (sIgE) to Week 17	6.460 Kilo Unit per Liter (kU/L) Interval 2.75 to 15.9	-2.990 Kilo Unit per Liter (kU/L) Interval -10.89 to -0.94	—	—

SECONDARY outcome

Timeframe: Baseline, Week 17

Population: FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized).

Measurement of Timothy Grass specific sIgE was performed in serum or plasma to determine effects on biomarkers of relevant physiological and pathogenic processes. Data was reported for Dupilumab + SCIT and placebo matched to Dupilumab + SCIT monotherapy group in this outcome measure. Missing value was imputed by LOCF method for visits between post-baseline to Week 17.

Outcome measures

Measure	SCIT n=26 Participants Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 to 7 days.	Dupilumab + SCIT n=26 Participants Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.	SCIT Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 to 7 days.	Dupilumab + SCIT Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.
Percent Change From Baseline in Serum Timothy Grass Specific Immunoglobulin E (sIgE) to Week 17	81.27 Percent Change Interval 21.27 to 179.41	-56.44 Percent Change Interval -68.0 to -37.2	—	—

SECONDARY outcome

Timeframe: Baseline, Week 17

Population: FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized).

Biomarkers measured in serum or plasma to determine effects on biomarkers of relevant physiological and pathogenic processes. Data was reported for Dupilumab + SCIT and placebo matched to Dupilumab + SCIT monotherapy group in this outcome measure. Missing value was imputed by LOCF method for visits between post-baseline to Week 17.

Outcome measures

Measure	SCIT n=26 Participants Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 to 7 days.	Dupilumab + SCIT n=26 Participants Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.	SCIT Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 to 7 days.	Dupilumab + SCIT Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.
Change From Baseline in Log-Transformed Value of Serum Timothy Grass Specific Immunoglobulin G4 (sIgG4) to Serum Timothy Grass Specific Immunoglobulin E (sIgE) Ratio to Week 17	0.745 Ratio Interval 0.21 to 1.4	1.720 Ratio Interval 1.36 to 2.13	—	—

SECONDARY outcome

Timeframe: Baseline through Week 24

Population: The safety analysis set (SAF) included all randomized participants who received at least one injection of study drug, it was based on the treatment received (as treated).

Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study [Week 24]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-participant hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.

Outcome measures

Measure	SCIT n=25 Participants Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 to 7 days.	Dupilumab + SCIT n=26 Participants Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.	SCIT n=26 Participants Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 to 7 days.	Dupilumab + SCIT n=26 Participants Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs Participants with TEAEs	21 Participants	18 Participants	24 Participants	22 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs Participants with Serious TEAEs	1 Participants	1 Participants	1 Participants	2 Participants

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Dupilumab

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

SCIT

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

Dupilumab + SCIT

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=25 participants at risk Participants received placebo matched to Dupilumab and placebo matched to Timothy grass subcutaneous immunotherapy (SCIT) every 2 weeks (Q2W) for 16 weeks. Both placebo doses were administered with a gap of 1 to 7 days.	Dupilumab n=26 participants at risk Participants received placebo matched to SCIT and subcutaneous (SC) injections of Dupilumab at a loading dose of 600 milligrams (mg) on Day 1, followed by a 300 mg for Q2W for 16 weeks. Both placebo matched to SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.	SCIT n=26 participants at risk Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 to 7 days.	Dupilumab + SCIT n=26 participants at risk Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.
Immune system disorders Hypersensitivity	0.00% 0/25 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	3.8% 1/26 • Number of events 1 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.
Infections and infestations Pyelonephritis	0.00% 0/25 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	3.8% 1/26 • Number of events 1 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.00% 0/25 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	3.8% 1/26 • Number of events 1 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.
Psychiatric disorders Anxiety	0.00% 0/25 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	3.8% 1/26 • Number of events 1 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.
Psychiatric disorders Bipolar disorder	4.0% 1/25 • Number of events 1 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.

Other adverse events

Measure	Placebo n=25 participants at risk Participants received placebo matched to Dupilumab and placebo matched to Timothy grass subcutaneous immunotherapy (SCIT) every 2 weeks (Q2W) for 16 weeks. Both placebo doses were administered with a gap of 1 to 7 days.	Dupilumab n=26 participants at risk Participants received placebo matched to SCIT and subcutaneous (SC) injections of Dupilumab at a loading dose of 600 milligrams (mg) on Day 1, followed by a 300 mg for Q2W for 16 weeks. Both placebo matched to SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.	SCIT n=26 participants at risk Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 to 7 days.	Dupilumab + SCIT n=26 participants at risk Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.
Gastrointestinal disorders Nausea	12.0% 3/25 • Number of events 3 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	7.7% 2/26 • Number of events 2 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	7.7% 2/26 • Number of events 2 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.
General disorders Chest discomfort	0.00% 0/25 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	7.7% 2/26 • Number of events 2 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.
General disorders Injection site bruising	4.0% 1/25 • Number of events 2 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	7.7% 2/26 • Number of events 3 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.
General disorders Injection site erythema	4.0% 1/25 • Number of events 3 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	3.8% 1/26 • Number of events 1 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	7.7% 2/26 • Number of events 5 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	15.4% 4/26 • Number of events 8 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.
General disorders Injection site induration	4.0% 1/25 • Number of events 1 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	19.2% 5/26 • Number of events 37 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	15.4% 4/26 • Number of events 35 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.
General disorders Injection site pruritus	4.0% 1/25 • Number of events 2 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	15.4% 4/26 • Number of events 12 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	11.5% 3/26 • Number of events 12 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.
General disorders Injection site reaction	32.0% 8/25 • Number of events 56 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	30.8% 8/26 • Number of events 64 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	42.3% 11/26 • Number of events 119 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	61.5% 16/26 • Number of events 342 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.
General disorders Injection site swelling	4.0% 1/25 • Number of events 1 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	11.5% 3/26 • Number of events 14 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	7.7% 2/26 • Number of events 16 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.
General disorders Injection site urticaria	4.0% 1/25 • Number of events 2 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	11.5% 3/26 • Number of events 12 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	7.7% 2/26 • Number of events 4 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.
General disorders Local reaction	0.00% 0/25 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	7.7% 2/26 • Number of events 3 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	3.8% 1/26 • Number of events 1 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.
Immune system disorders Anaphylactic reaction	0.00% 0/25 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	3.8% 1/26 • Number of events 1 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	7.7% 2/26 • Number of events 2 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	3.8% 1/26 • Number of events 1 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.
Immune system disorders Hypersensitivity	0.00% 0/25 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	15.4% 4/26 • Number of events 5 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	30.8% 8/26 • Number of events 11 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.
Infections and infestations Gastroenteritis	8.0% 2/25 • Number of events 2 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.
Infections and infestations Influenza	0.00% 0/25 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	3.8% 1/26 • Number of events 1 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	7.7% 2/26 • Number of events 2 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.
Infections and infestations Nasopharyngitis	20.0% 5/25 • Number of events 9 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	19.2% 5/26 • Number of events 5 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	3.8% 1/26 • Number of events 1 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	38.5% 10/26 • Number of events 11 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.
Infections and infestations Upper respiratory tract infection	20.0% 5/25 • Number of events 5 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	15.4% 4/26 • Number of events 4 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	3.8% 1/26 • Number of events 1 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.
Infections and infestations Urinary tract infection	0.00% 0/25 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	7.7% 2/26 • Number of events 2 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	3.8% 1/26 • Number of events 1 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.
Infections and infestations Viral upper respiratory tract infection	12.0% 3/25 • Number of events 4 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	3.8% 1/26 • Number of events 2 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.
Investigations Blood creatine phosphokinase increased	4.0% 1/25 • Number of events 1 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	7.7% 2/26 • Number of events 2 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	3.8% 1/26 • Number of events 1 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/25 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	7.7% 2/26 • Number of events 4 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/25 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	7.7% 2/26 • Number of events 2 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/25 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	7.7% 2/26 • Number of events 3 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.
Nervous system disorders Headache	12.0% 3/25 • Number of events 10 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	3.8% 1/26 • Number of events 4 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	3.8% 1/26 • Number of events 1 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	3.8% 1/26 • Number of events 1 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.
Respiratory, thoracic and mediastinal disorders Nasal congestion	4.0% 1/25 • Number of events 1 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	3.8% 1/26 • Number of events 1 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	11.5% 3/26 • Number of events 3 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/25 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	3.8% 1/26 • Number of events 1 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	7.7% 2/26 • Number of events 3 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.	0.00% 0/26 • Adverse event information was collected from the time the informed consent was signed until the participant's last study visit, regardless of seriousness or relationship to investigational product.Treatment-emergent adverse events were reported for the 16-week treatment period and the 8-week follow-up period. Reported AEs are treatment-emergent adverse events, which are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the treatment emergent period. The safety analysis set (SAF) included all randomized participants who received any study drug; it was based on the treatment received (as treated). The safety analyses were based on the SAF.

Additional Information

Clinical Trial Administrator

Regeneron Pharmaceuticals, Inc

Phone: 844-734-6643

Email: clinicaltrials@regeneron.com

Results disclosure agreements

• Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
• Publication restrictions are in place

Restriction type: OTHER