Trial Outcomes & Findings for A Study to Evaluate the Safety and Effectiveness of Ustekinumab or Golimumab Administered Subcutaneously (SC) in Patients With Sarcoidosis (NCT NCT00955279)
NCT ID: NCT00955279
Last Updated: 2014-07-17
Results Overview
Forced vital capacity (FVC) is a standard pulmonary function test used to quantify respiratory muscle weakness . FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) \* 100%. Change was calculated as the value at Week 16 minus the baseline value.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
173 participants
Primary outcome timeframe
Baseline (Day 1) and Week 16
Results posted on
2014-07-17
Participant Flow
Participant milestones
| Measure |
Placebo
Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
|
Golimumab
Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
|
Ustekinumab
Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
|
|---|---|---|---|
|
Overall Study
STARTED
|
58
|
55
|
60
|
|
Overall Study
COMPLETED
|
55
|
51
|
52
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
8
|
Reasons for withdrawal
| Measure |
Placebo
Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
|
Golimumab
Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
|
Ustekinumab
Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
|
|---|---|---|---|
|
Overall Study
Other
|
0
|
0
|
3
|
|
Overall Study
Death
|
1
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
3
|
Baseline Characteristics
A Study to Evaluate the Safety and Effectiveness of Ustekinumab or Golimumab Administered Subcutaneously (SC) in Patients With Sarcoidosis
Baseline characteristics by cohort
| Measure |
Placebo
n=58 Participants
Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
|
Golimumab
n=55 Participants
Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
|
Ustekinumab
n=60 Participants
Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
|
Total
n=173 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49.5 Years
STANDARD_DEVIATION 9.51 • n=99 Participants
|
50.0 Years
STANDARD_DEVIATION 9.44 • n=107 Participants
|
49.8 Years
STANDARD_DEVIATION 10.17 • n=206 Participants
|
49.8 Years
STANDARD_DEVIATION 9.67 • n=7 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
85 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
88 Participants
n=7 Participants
|
|
Number of Participants by stratification factors
Both Pulmonary and Skin
|
6 participants
n=99 Participants
|
4 participants
n=107 Participants
|
7 participants
n=206 Participants
|
17 participants
n=7 Participants
|
|
Number of Participants by stratification factors
Pulmonary Only
|
38 participants
n=99 Participants
|
38 participants
n=107 Participants
|
39 participants
n=206 Participants
|
115 participants
n=7 Participants
|
|
Number of Participants by stratification factors
Skin Only
|
14 participants
n=99 Participants
|
13 participants
n=107 Participants
|
14 participants
n=206 Participants
|
41 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Week 16Population: Modified intent-to-treat (mITT) population included all the participants who were randomized and who received at least 1 dose of study medication.
Forced vital capacity (FVC) is a standard pulmonary function test used to quantify respiratory muscle weakness . FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) \* 100%. Change was calculated as the value at Week 16 minus the baseline value.
Outcome measures
| Measure |
Placebo
n=44 Participants
Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
|
Golimumab
n=42 Participants
Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
|
Ustekinumab
n=46 Participants
Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
|
|---|---|---|---|
|
Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 16
|
2.02 percent of predicted FVC
Standard Error 1.350
|
1.15 percent of predicted FVC
Standard Error 1.413
|
-0.15 percent of predicted FVC
Standard Error 1.279
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 28Population: mITT population included all the participants who were randomized and who received at least 1 dose of study medication.
Change from Baseline in 6-minute walk distance at Week 28 was calculated as 6-minute walk distance at Week 28 minus 6-minute walk distance at Baseline. The 6-minute walk distance was the total distance walked during the 6-minute walk test.
Outcome measures
| Measure |
Placebo
n=44 Participants
Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
|
Golimumab
n=42 Participants
Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
|
Ustekinumab
n=46 Participants
Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
|
|---|---|---|---|
|
Change From Baseline in 6-minute Walk Distance at Week 28
|
14.52 meters
Standard Error 14.223
|
12.53 meters
Standard Error 14.919
|
-13.22 meters
Standard Error 13.584
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 28Population: mITT population included all the participants who were randomized and who received at least 1 dose of study medication.
St. George's Respiratory Questionnaire (SGRQ) is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life. Change from Baseline was calculated as the value at Week 28 minus value at Baseline.
Outcome measures
| Measure |
Placebo
n=44 Participants
Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
|
Golimumab
n=42 Participants
Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
|
Ustekinumab
n=46 Participants
Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
|
|---|---|---|---|
|
Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 28
|
-9.50 Units on a scale
Standard Error 2.790
|
-6.86 Units on a scale
Standard Error 2.921
|
-4.25 Units on a scale
Standard Error 2.662
|
SECONDARY outcome
Timeframe: Week 28Population: Secondary population included all the participants with chronic sarcoidosis with skin involvement who have received at least 1 dose of study medication.
The SPGA is 7-point scale used to assess the condition of skin in participants. The physician checks the state of the skin and gives them score from 0 (clear) to 5 (severe). Higher scores indicate worsening of skin condition.
Outcome measures
| Measure |
Placebo
n=20 Participants
Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
|
Golimumab
n=17 Participants
Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
|
Ustekinumab
n=21 Participants
Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
|
|---|---|---|---|
|
Percentage of Responders With a Score of Less Than or Equal to 1 on Skin Physician's Global Assessment (SPGA) Scale
|
30.0 Percentage of Participants
2.790
|
52.9 Percentage of Participants
2.921
|
14.3 Percentage of Participants
2.662
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 28Population: mITT population included all the participants who were randomized and who received at least 1 dose of study medication.
Forced vital capacity (FVC) is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) \* 100%. Change is calculated as the value at week 28 minus the baseline value.
Outcome measures
| Measure |
Placebo
n=44 Participants
Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
|
Golimumab
n=42 Participants
Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
|
Ustekinumab
n=46 Participants
Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
|
|---|---|---|---|
|
Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 28
|
1.59 percent of predicted FVC
Standard Error 1.621
|
0.29 percent of predicted FVC
Standard Error 1.697
|
0.56 percent of predicted FVC
Standard Error 1.536
|
Adverse Events
Placebo
Serious events: 9 serious events
Other events: 52 other events
Deaths: 0 deaths
Golimumab
Serious events: 7 serious events
Other events: 49 other events
Deaths: 0 deaths
Ustekinumab
Serious events: 10 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=58 participants at risk
Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
|
Golimumab
n=55 participants at risk
Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
|
Ustekinumab
n=60 participants at risk
Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
|
|---|---|---|---|
|
Infections and infestations
Bronchitis
|
1.7%
1/58 • Baseline and Week 16
|
1.8%
1/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/58 • Baseline and Week 16
|
1.8%
1/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
Infections and infestations
Pneumonia
|
0.00%
0/58 • Baseline and Week 16
|
1.8%
1/55 • Baseline and Week 16
|
5.0%
3/60 • Baseline and Week 16
|
|
Infections and infestations
Sepsis
|
0.00%
0/58 • Baseline and Week 16
|
1.8%
1/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
Infections and infestations
Septic shock
|
0.00%
0/58 • Baseline and Week 16
|
1.8%
1/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/58 • Baseline and Week 16
|
1.8%
1/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
Infections and infestations
Abscess
|
1.7%
1/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
1.7%
1/60 • Baseline and Week 16
|
|
Infections and infestations
Influenza
|
1.7%
1/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
Infections and infestations
Oesophageal candidiasis
|
1.7%
1/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
1.7%
1/60 • Baseline and Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/58 • Baseline and Week 16
|
1.8%
1/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal cyst
|
0.00%
0/58 • Baseline and Week 16
|
1.8%
1/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.00%
0/58 • Baseline and Week 16
|
1.8%
1/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
1.7%
1/60 • Baseline and Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.7%
1/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
1.7%
1/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
1.7%
1/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.7%
1/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
1.7%
1/60 • Baseline and Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary sarcoidosis
|
1.7%
1/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/58 • Baseline and Week 16
|
1.8%
1/55 • Baseline and Week 16
|
1.7%
1/60 • Baseline and Week 16
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
1.7%
1/60 • Baseline and Week 16
|
|
General disorders
Pyrexia
|
0.00%
0/58 • Baseline and Week 16
|
1.8%
1/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
General disorders
Sudden death
|
1.7%
1/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/58 • Baseline and Week 16
|
1.8%
1/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/58 • Baseline and Week 16
|
1.8%
1/55 • Baseline and Week 16
|
1.7%
1/60 • Baseline and Week 16
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
1.7%
1/60 • Baseline and Week 16
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/58 • Baseline and Week 16
|
1.8%
1/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
Psychiatric disorders
Affective disorder
|
1.7%
1/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
1.7%
1/60 • Baseline and Week 16
|
|
Psychiatric disorders
Major depression
|
1.7%
1/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
Psychiatric disorders
Suicidal ideation
|
1.7%
1/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.7%
1/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.00%
0/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
1.7%
1/60 • Baseline and Week 16
|
|
Gastrointestinal disorders
Diverticular perforation
|
1.7%
1/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
Immune system disorders
Sarcoidosis
|
1.7%
1/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
1.7%
1/60 • Baseline and Week 16
|
|
Injury, poisoning and procedural complications
Radius fracture
|
1.7%
1/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
1.7%
1/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
Injury, poisoning and procedural complications
Traumatic renal injury
|
1.7%
1/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
Investigations
Psychiatric evaluation
|
0.00%
0/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
1.7%
1/60 • Baseline and Week 16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
1.7%
1/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
Nervous system disorders
Cerebral sarcoidosis
|
1.7%
1/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
Renal and urinary disorders
Urethral disorder
|
1.7%
1/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
Vascular disorders
Vasculitis
|
0.00%
0/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
1.7%
1/60 • Baseline and Week 16
|
Other adverse events
| Measure |
Placebo
n=58 participants at risk
Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
|
Golimumab
n=55 participants at risk
Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
|
Ustekinumab
n=60 participants at risk
Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
5.2%
3/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
3.3%
2/60 • Baseline and Week 16
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
5.2%
3/58 • Baseline and Week 16
|
1.8%
1/55 • Baseline and Week 16
|
3.3%
2/60 • Baseline and Week 16
|
|
Gastrointestinal disorders
Constipation
|
3.4%
2/58 • Baseline and Week 16
|
5.5%
3/55 • Baseline and Week 16
|
5.0%
3/60 • Baseline and Week 16
|
|
Gastrointestinal disorders
Diarrhoea
|
19.0%
11/58 • Baseline and Week 16
|
10.9%
6/55 • Baseline and Week 16
|
15.0%
9/60 • Baseline and Week 16
|
|
Gastrointestinal disorders
Nausea
|
10.3%
6/58 • Baseline and Week 16
|
12.7%
7/55 • Baseline and Week 16
|
13.3%
8/60 • Baseline and Week 16
|
|
Gastrointestinal disorders
Vomiting
|
12.1%
7/58 • Baseline and Week 16
|
7.3%
4/55 • Baseline and Week 16
|
10.0%
6/60 • Baseline and Week 16
|
|
General disorders
Chest Discomfort
|
0.00%
0/58 • Baseline and Week 16
|
1.8%
1/55 • Baseline and Week 16
|
5.0%
3/60 • Baseline and Week 16
|
|
General disorders
Chills
|
0.00%
0/58 • Baseline and Week 16
|
1.8%
1/55 • Baseline and Week 16
|
5.0%
3/60 • Baseline and Week 16
|
|
General disorders
Fatigue
|
13.8%
8/58 • Baseline and Week 16
|
20.0%
11/55 • Baseline and Week 16
|
20.0%
12/60 • Baseline and Week 16
|
|
General disorders
Influenza Like Illness
|
5.2%
3/58 • Baseline and Week 16
|
3.6%
2/55 • Baseline and Week 16
|
5.0%
3/60 • Baseline and Week 16
|
|
General disorders
Injection Site Erythema
|
0.00%
0/58 • Baseline and Week 16
|
7.3%
4/55 • Baseline and Week 16
|
1.7%
1/60 • Baseline and Week 16
|
|
General disorders
Injection Site Pain
|
1.7%
1/58 • Baseline and Week 16
|
5.5%
3/55 • Baseline and Week 16
|
1.7%
1/60 • Baseline and Week 16
|
|
General disorders
Injection Site Pruritus
|
1.7%
1/58 • Baseline and Week 16
|
5.5%
3/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
General disorders
Malaise
|
0.00%
0/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
5.0%
3/60 • Baseline and Week 16
|
|
General disorders
Non-Cardiac Chest Pain
|
8.6%
5/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
General disorders
Oedema Peripheral
|
8.6%
5/58 • Baseline and Week 16
|
14.5%
8/55 • Baseline and Week 16
|
6.7%
4/60 • Baseline and Week 16
|
|
General disorders
Pyrexia
|
5.2%
3/58 • Baseline and Week 16
|
7.3%
4/55 • Baseline and Week 16
|
8.3%
5/60 • Baseline and Week 16
|
|
Immune system disorders
Sarcoidosis
|
5.2%
3/58 • Baseline and Week 16
|
7.3%
4/55 • Baseline and Week 16
|
16.7%
10/60 • Baseline and Week 16
|
|
Infections and infestations
Bronchitis
|
13.8%
8/58 • Baseline and Week 16
|
12.7%
7/55 • Baseline and Week 16
|
13.3%
8/60 • Baseline and Week 16
|
|
Infections and infestations
Herpes Zoster
|
5.2%
3/58 • Baseline and Week 16
|
1.8%
1/55 • Baseline and Week 16
|
3.3%
2/60 • Baseline and Week 16
|
|
Infections and infestations
Influenza
|
0.00%
0/58 • Baseline and Week 16
|
5.5%
3/55 • Baseline and Week 16
|
1.7%
1/60 • Baseline and Week 16
|
|
Infections and infestations
Nasopharyngitis
|
3.4%
2/58 • Baseline and Week 16
|
7.3%
4/55 • Baseline and Week 16
|
15.0%
9/60 • Baseline and Week 16
|
|
Infections and infestations
Oral Herpes
|
5.2%
3/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
1.7%
1/60 • Baseline and Week 16
|
|
Infections and infestations
Respiratory Tract
|
3.4%
2/58 • Baseline and Week 16
|
7.3%
4/55 • Baseline and Week 16
|
5.0%
3/60 • Baseline and Week 16
|
|
Infections and infestations
Sinusitis
|
15.5%
9/58 • Baseline and Week 16
|
5.5%
3/55 • Baseline and Week 16
|
8.3%
5/60 • Baseline and Week 16
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
22.4%
13/58 • Baseline and Week 16
|
10.9%
6/55 • Baseline and Week 16
|
16.7%
10/60 • Baseline and Week 16
|
|
Infections and infestations
Urinary Tract Infection
|
5.2%
3/58 • Baseline and Week 16
|
1.8%
1/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
1.7%
1/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
6.7%
4/60 • Baseline and Week 16
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/58 • Baseline and Week 16
|
1.8%
1/55 • Baseline and Week 16
|
5.0%
3/60 • Baseline and Week 16
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/58 • Baseline and Week 16
|
1.8%
1/55 • Baseline and Week 16
|
5.0%
3/60 • Baseline and Week 16
|
|
Investigations
Weight Increased
|
5.2%
3/58 • Baseline and Week 16
|
1.8%
1/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
5.2%
3/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
Metabolism and nutrition disorders
Gout
|
5.2%
3/58 • Baseline and Week 16
|
3.6%
2/55 • Baseline and Week 16
|
1.7%
1/60 • Baseline and Week 16
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
27.6%
16/58 • Baseline and Week 16
|
23.6%
13/55 • Baseline and Week 16
|
15.0%
9/60 • Baseline and Week 16
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.3%
6/58 • Baseline and Week 16
|
10.9%
6/55 • Baseline and Week 16
|
15.0%
9/60 • Baseline and Week 16
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.00%
0/58 • Baseline and Week 16
|
5.5%
3/55 • Baseline and Week 16
|
3.3%
2/60 • Baseline and Week 16
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
3.4%
2/58 • Baseline and Week 16
|
9.1%
5/55 • Baseline and Week 16
|
8.3%
5/60 • Baseline and Week 16
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
6.9%
4/58 • Baseline and Week 16
|
1.8%
1/55 • Baseline and Week 16
|
3.3%
2/60 • Baseline and Week 16
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
5.2%
3/58 • Baseline and Week 16
|
3.6%
2/55 • Baseline and Week 16
|
1.7%
1/60 • Baseline and Week 16
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.00%
0/58 • Baseline and Week 16
|
1.8%
1/55 • Baseline and Week 16
|
6.7%
4/60 • Baseline and Week 16
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.7%
1/58 • Baseline and Week 16
|
5.5%
3/55 • Baseline and Week 16
|
3.3%
2/60 • Baseline and Week 16
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
5.2%
3/58 • Baseline and Week 16
|
3.6%
2/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
19.0%
11/58 • Baseline and Week 16
|
5.5%
3/55 • Baseline and Week 16
|
13.3%
8/60 • Baseline and Week 16
|
|
Nervous system disorders
Burning Sensation
|
0.00%
0/58 • Baseline and Week 16
|
1.8%
1/55 • Baseline and Week 16
|
5.0%
3/60 • Baseline and Week 16
|
|
Nervous system disorders
Headache
|
20.7%
12/58 • Baseline and Week 16
|
12.7%
7/55 • Baseline and Week 16
|
20.0%
12/60 • Baseline and Week 16
|
|
Nervous system disorders
Migraine
|
5.2%
3/58 • Baseline and Week 16
|
1.8%
1/55 • Baseline and Week 16
|
0.00%
0/60 • Baseline and Week 16
|
|
Psychiatric disorders
Depression
|
5.2%
3/58 • Baseline and Week 16
|
3.6%
2/55 • Baseline and Week 16
|
3.3%
2/60 • Baseline and Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.9%
15/58 • Baseline and Week 16
|
20.0%
11/55 • Baseline and Week 16
|
21.7%
13/60 • Baseline and Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
19.0%
11/58 • Baseline and Week 16
|
18.2%
10/55 • Baseline and Week 16
|
6.7%
4/60 • Baseline and Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
3.4%
2/58 • Baseline and Week 16
|
1.8%
1/55 • Baseline and Week 16
|
5.0%
3/60 • Baseline and Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
6.9%
4/58 • Baseline and Week 16
|
3.6%
2/55 • Baseline and Week 16
|
11.7%
7/60 • Baseline and Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
3.4%
2/58 • Baseline and Week 16
|
1.8%
1/55 • Baseline and Week 16
|
6.7%
4/60 • Baseline and Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Congestion
|
5.2%
3/58 • Baseline and Week 16
|
1.8%
1/55 • Baseline and Week 16
|
1.7%
1/60 • Baseline and Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.9%
4/58 • Baseline and Week 16
|
3.6%
2/55 • Baseline and Week 16
|
6.7%
4/60 • Baseline and Week 16
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.2%
3/58 • Baseline and Week 16
|
7.3%
4/55 • Baseline and Week 16
|
6.7%
4/60 • Baseline and Week 16
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.3%
6/58 • Baseline and Week 16
|
10.9%
6/55 • Baseline and Week 16
|
10.0%
6/60 • Baseline and Week 16
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
13.8%
8/58 • Baseline and Week 16
|
1.8%
1/55 • Baseline and Week 16
|
10.0%
6/60 • Baseline and Week 16
|
|
Vascular disorders
Hypertension
|
5.2%
3/58 • Baseline and Week 16
|
0.00%
0/55 • Baseline and Week 16
|
6.7%
4/60 • Baseline and Week 16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60