Trial Outcomes & Findings for Dupilumab in Eosinophilic Gastritis (NCT NCT03678545)

Last Updated: 2025-11-04

Results Overview

We will determine the Relative change from baseline of the peak eosinophil counts in the 5 most eosinophil dense HPFs in the gastric antrum and/or body between drug vs placebo at 12 weeks will be the primary measurement endpoint.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

41 participants

Primary outcome timeframe

12 weeks after randomization

Results posted on

2025-11-04

Participant Flow

Participant milestones

Participant milestones
Measure	Dupilumab Dupilumab (blinded): Subcutaneous injection every two weeks as follows: 600 mg initial dose, and 300 mg subsequent doses for a total of 6 injections.	Placebo Placebo (blinded): Placebo is matched to the active drug (dupilumab), and is given in the same manner: a subcutaneous injection every two weeks for a total of 6 injections. Open Label extension Placebo group to be treated with dupilumab.
Double Blinded Phase STARTED	21	20
Double Blinded Phase COMPLETED	21	19
Double Blinded Phase NOT COMPLETED	0	1
Open Label Extension STARTED	21	19
Open Label Extension COMPLETED	20	17
Open Label Extension NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dupilumab in Eosinophilic Gastritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dupilumab n=21 Participants Dupilumab (blinded): Subcutaneous injection every two weeks as follows: 600 mg initial dose, and 300 mg subsequent doses for a total of 6 injections.	Placebo n=20 Participants Placebo (blinded): Placebo is matched to the active drug (dupilumab), and is given in the same manner: a subcutaneous injection every two weeks for a total of 6 injections.	Total n=41 Participants Total of all reporting groups
Age, Categorical <=18 years	5 Participants n=15 Participants	5 Participants n=161 Participants	10 Participants n=100 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=15 Participants	15 Participants n=161 Participants	31 Participants n=100 Participants
Age, Categorical >=65 years	0 Participants n=15 Participants	0 Participants n=161 Participants	0 Participants n=100 Participants
Age, Continuous	30.3 years n=15 Participants	30.7 years n=161 Participants	30.4 years n=100 Participants
Sex: Female, Male Female	15 Participants n=15 Participants	10 Participants n=161 Participants	25 Participants n=100 Participants
Sex: Female, Male Male	6 Participants n=15 Participants	10 Participants n=161 Participants	16 Participants n=100 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=15 Participants	1 Participants n=161 Participants	1 Participants n=100 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=15 Participants	19 Participants n=161 Participants	40 Participants n=100 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants	0 Participants n=161 Participants	0 Participants n=100 Participants
Region of Enrollment United States	21 participants n=15 Participants	20 participants n=161 Participants	41 participants n=100 Participants

PRIMARY outcome

Timeframe: 12 weeks after randomization

Outcome measures

Outcome measures
Measure	Dupilumab n=21 Participants Dupilumab (blinded): Subcutaneous injection every two weeks as follows: 600 mg initial dose, and 300 mg subsequent doses for a total of 6 injections.	Placebo n=19 Participants Placebo (blinded): Placebo is matched to the active drug (dupilumab), and is given in the same manner: a subcutaneous injection every two weeks for a total of 6 injections.
Relative Change of Peak Eosinophil Counts in the Stomach	-50.28 Eosinophil per HPF (EOS/HPF) Interval -66.2 to -34.37	-3.54 Eosinophil per HPF (EOS/HPF) Interval -20.27 to 13.19

Adverse Events

Experimental Phase - Dupilumab

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Experimental Phase - Placebo

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Open Label Phase - Dupilumab

Serious events: 0 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Regina Yearout

Cincinnati Children's Hospital Medical Center

Phone: 513-517-2108

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Experimental Phase - Dupilumab n=21 participants at risk Dupilumab (blinded): Subcutaneous injection every two weeks as follows: 600 mg initial dose, and 300 mg subsequent doses for a total of 6 injections.	Experimental Phase - Placebo n=20 participants at risk Placebo (blinded): Placebo is matched to the active drug (dupilumab), and is given in the same manner: a subcutaneous injection every two weeks for a total of 6 injections.	Open Label Phase - Dupilumab n=40 participants at risk Post experimental phase, all participants were offered an open-label extension.
Respiratory, thoracic and mediastinal disorders Cold like symptoms	19.0% 4/21 • Number of events 12 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	15.0% 3/20 • Number of events 4 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	10.0% 4/40 • Number of events 8 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Skin and subcutaneous tissue disorders Rashes	9.5% 2/21 • Number of events 2 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	25.0% 5/20 • Number of events 5 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	12.5% 5/40 • Number of events 6 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Vascular disorders Hypertension	0.00% 0/21 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	5.0% 1/20 • Number of events 1 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	0.00% 0/40 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Cardiac disorders Myocardial Infraction	0.00% 0/21 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	0.00% 0/20 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	2.5% 1/40 • Number of events 1 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Cardiac disorders Elevated blood pressure	0.00% 0/21 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	0.00% 0/20 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	2.5% 1/40 • Number of events 1 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Eye disorders Blurred vision	0.00% 0/21 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	5.0% 1/20 • Number of events 1 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	2.5% 1/40 • Number of events 1 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Eye disorders Watery eyes	0.00% 0/21 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	0.00% 0/20 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	2.5% 1/40 • Number of events 1 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Gastrointestinal disorders Constipation	0.00% 0/21 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	5.0% 1/20 • Number of events 1 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	0.00% 0/40 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Gastrointestinal disorders Diarrhea	0.00% 0/21 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	0.00% 0/20 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	7.5% 3/40 • Number of events 3 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Gastrointestinal disorders Dysphagia	0.00% 0/21 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	0.00% 0/20 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	2.5% 1/40 • Number of events 1 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Gastrointestinal disorders Gastroesophageal reflux	0.00% 0/21 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	0.00% 0/20 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	5.0% 2/40 • Number of events 2 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Gastrointestinal disorders EOG symptoms worsened	0.00% 0/21 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	0.00% 0/20 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	2.5% 1/40 • Number of events 1 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Gastrointestinal disorders Nausea	0.00% 0/21 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	0.00% 0/20 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	7.5% 3/40 • Number of events 3 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Gastrointestinal disorders Pancreatitis	0.00% 0/21 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	0.00% 0/20 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	2.5% 1/40 • Number of events 1 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Gastrointestinal disorders Stomach Pain	0.00% 0/21 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	5.0% 1/20 • Number of events 1 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	2.5% 1/40 • Number of events 1 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Gastrointestinal disorders Vomiting	0.00% 0/21 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	0.00% 0/20 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	10.0% 4/40 • Number of events 5 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Metabolism and nutrition disorders weight gain	0.00% 0/21 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	0.00% 0/20 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	2.5% 1/40 • Number of events 1 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Nervous system disorders Dizziness	0.00% 0/21 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	0.00% 0/20 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	5.0% 2/40 • Number of events 2 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Nervous system disorders Priapism	0.00% 0/21 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	5.0% 1/20 • Number of events 1 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	0.00% 0/40 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Nervous system disorders Presyncope	4.8% 1/21 • Number of events 1 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	0.00% 0/20 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	0.00% 0/40 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Nervous system disorders Recurrent laryngeal nerve palsy	4.8% 1/21 • Number of events 1 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	0.00% 0/20 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	0.00% 0/40 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Blood and lymphatic system disorders Eosinophilia	28.6% 6/21 • Number of events 10 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	25.0% 5/20 • Number of events 7 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	20.0% 8/40 • Number of events 21 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Cardiac disorders Cardiovascular events - Tachycardia	0.00% 0/21 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	0.00% 0/20 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	5.0% 2/40 • Number of events 3 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Ear and labyrinth disorders Tinnitus	0.00% 0/21 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	0.00% 0/20 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	2.5% 1/40 • Number of events 1 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Eye disorders Eye Pain/Swelling	0.00% 0/21 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	5.0% 1/20 • Number of events 1 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	7.5% 3/40 • Number of events 3 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Gastrointestinal disorders Abdominal Pain	0.00% 0/21 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	0.00% 0/20 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	2.5% 1/40 • Number of events 1 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
General disorders Injection reaction	57.1% 12/21 • Number of events 30 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	20.0% 4/20 • Number of events 5 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	47.5% 19/40 • Number of events 59 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Immune system disorders Allergic reaction	4.8% 1/21 • Number of events 2 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	0.00% 0/20 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	2.5% 1/40 • Number of events 1 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Infections and infestations Infections	28.6% 6/21 • Number of events 8 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	45.0% 9/20 • Number of events 12 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	37.5% 15/40 • Number of events 25 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Injury, poisoning and procedural complications Bruising	0.00% 0/21 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	5.0% 1/20 • Number of events 1 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	7.5% 3/40 • Number of events 3 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Investigations Low iron	4.8% 1/21 • Number of events 1 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	0.00% 0/20 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	0.00% 0/40 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/21 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	0.00% 0/20 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	2.5% 1/40 • Number of events 1 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Musculoskeletal and connective tissue disorders Musculoskeletal irritations	4.8% 1/21 • Number of events 1 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	15.0% 3/20 • Number of events 3 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	15.0% 6/40 • Number of events 6 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/21 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	0.00% 0/20 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	2.5% 1/40 • Number of events 1 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Nervous system disorders Headache	4.8% 1/21 • Number of events 2 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	10.0% 2/20 • Number of events 2 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	10.0% 4/40 • Number of events 4 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Psychiatric disorders Anxiety	0.00% 0/21 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	5.0% 1/20 • Number of events 1 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	0.00% 0/40 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.
Renal and urinary disorders Renal pain	0.00% 0/21 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	5.0% 1/20 • Number of events 1 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.	0.00% 0/40 • From informed consent to 4 weeks after the end of the 12-week double-blind, approximately 20 weeks on average, followed by open-label treatment phase of 24 weeks. approximately a total of 44 weeks.