Trial Outcomes & Findings for Study of Safety, Tolerability and Efficacy of DFV890 in Participants With Familial Cold Auto-inflammatory Syndrome (FCAS) (NCT NCT04868968)
NCT ID: NCT04868968
Last Updated: 2024-10-09
Results Overview
A cold challenge was performed during the screening period and on Day 4 of the treatment period. Fold change from pre-challenge to highest post-challenge value of WCC was defined as the ratio of the highest post-challenge WCC value to the pre-challenge WCC value. The ratio of fold change was defined as treatment fold change divided by the screen fold change. A value of less than 1 for the ratio of fold change indicates a lower relative increase of WCC in the treatment than in the screening period, which is a favorable outcome. The log-transformed fold change from pre-challenge to the highest post challenge WCC was analyzed using a log-linear mixed effect model. The analysis was carried out considering the data from -2 to 8 hrs post challenge. The unforeseen screen failure rate and recruitment challenges resulted in early closure of the study. Only 4 out of planned 6 participants were enrolled in the study; thus, the results should be interpreted cautiously.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
Screening period and treatment period (Day 4): pre cold challenge and up to 8 hours post cold challenge. The duration of the cold challenge was 45 minutes.
Results posted on
2024-10-09
Participant Flow
Participants took part in 3 investigative sites in 3 countries.
During the screening period the participant's eligibility was assessed at a screening visit and a screening cold challenge was performed.
Participant milestones
| Measure |
DFV890 100mg - Treatment
DFV890 100mg oral dose, twice daily for 3 days and one last dose in the morning of Day 4 of the treatment period
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
DFV890 100mg - Treatment
DFV890 100mg oral dose, twice daily for 3 days and one last dose in the morning of Day 4 of the treatment period
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Study of Safety, Tolerability and Efficacy of DFV890 in Participants With Familial Cold Auto-inflammatory Syndrome (FCAS)
Baseline characteristics by cohort
| Measure |
DFV890 100mg - Treatment
n=4 Participants
DFV890 100mg oral dose, twice daily for 3 days and one last dose in the morning of Day 4 of the treatment period
|
|---|---|
|
Age, Continuous
|
41.3 years
STANDARD_DEVIATION 15.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
other
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
white
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Screening period and treatment period (Day 4): pre cold challenge and up to 8 hours post cold challenge. The duration of the cold challenge was 45 minutes.Population: The Pharmacodynamic (PD) analysis set included all participants with no protocol deviations with relevant impact on PD data.
A cold challenge was performed during the screening period and on Day 4 of the treatment period. Fold change from pre-challenge to highest post-challenge value of WCC was defined as the ratio of the highest post-challenge WCC value to the pre-challenge WCC value. The ratio of fold change was defined as treatment fold change divided by the screen fold change. A value of less than 1 for the ratio of fold change indicates a lower relative increase of WCC in the treatment than in the screening period, which is a favorable outcome. The log-transformed fold change from pre-challenge to the highest post challenge WCC was analyzed using a log-linear mixed effect model. The analysis was carried out considering the data from -2 to 8 hrs post challenge. The unforeseen screen failure rate and recruitment challenges resulted in early closure of the study. Only 4 out of planned 6 participants were enrolled in the study; thus, the results should be interpreted cautiously.
Outcome measures
| Measure |
DFV890 100mg
n=4 Participants
DFV890 100mg oral dose, twice daily for 3 days and one last dose in the morning of Day 4 of the treatment period
|
DFV890 100mg - Treatment
DFV890 100mg oral dose, twice daily for 3 days and one last dose in the morning of Day 4 of the treatment period
|
|---|---|---|
|
Ratio of Fold Change From Pre-challenge to the Highest Post-challenge Value of White Cell Count (WCC) Between Treatment and Screening Period
|
0.82 ratio of fold change
Interval 0.56 to 1.21
|
—
|
SECONDARY outcome
Timeframe: Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 34 daysPopulation: The safety analysis set included all participants that received any study drug.
Number of participants with treatment emergent AEs (any AE regardless of seriousness), AEs led to study treatment discontinuation, SAEs and SAEs led to study treatment discontinuation.
Outcome measures
| Measure |
DFV890 100mg
n=4 Participants
DFV890 100mg oral dose, twice daily for 3 days and one last dose in the morning of Day 4 of the treatment period
|
DFV890 100mg - Treatment
DFV890 100mg oral dose, twice daily for 3 days and one last dose in the morning of Day 4 of the treatment period
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
At least one AE
|
4 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
At least one SAE
|
0 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE leading to discontinuation
|
0 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAE leading to discontinuation
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Screening and Treatment (Day 4): 1 hour pre and 2, 3, 5, 9 and 24 hours post. Scheduled time refers to the time post-meal (screening) and to the time post-dose (treatment). The start of the cold challenge is at 1 hour post and the duration is 45 minutes.Population: The Pharmacodynamic (PD) analysis set included all participants with no protocol deviations with relevant impact on PD data.
The Physician global assessment of autoinflammatory disease activity is a questionnaire completed by the Investigator. It uses a 5-point scale. Lower scores represent better outcomes. 0 = Absent 1. = Minimal 2. = Mild 3. = Moderate 4. = Severe
Outcome measures
| Measure |
DFV890 100mg
n=4 Participants
DFV890 100mg oral dose, twice daily for 3 days and one last dose in the morning of Day 4 of the treatment period
|
DFV890 100mg - Treatment
n=4 Participants
DFV890 100mg oral dose, twice daily for 3 days and one last dose in the morning of Day 4 of the treatment period
|
|---|---|---|
|
Physician Global Assessment of Autoinflammatory Disease Activity
1 hour pre · Absent
|
0 Participants
|
2 Participants
|
|
Physician Global Assessment of Autoinflammatory Disease Activity
1 hour pre · Minimal
|
3 Participants
|
2 Participants
|
|
Physician Global Assessment of Autoinflammatory Disease Activity
1 hour pre · Mild
|
1 Participants
|
0 Participants
|
|
Physician Global Assessment of Autoinflammatory Disease Activity
1 hour pre · Moderate
|
0 Participants
|
0 Participants
|
|
Physician Global Assessment of Autoinflammatory Disease Activity
1 hour pre · Severe
|
0 Participants
|
0 Participants
|
|
Physician Global Assessment of Autoinflammatory Disease Activity
2 hours post · Absent
|
0 Participants
|
2 Participants
|
|
Physician Global Assessment of Autoinflammatory Disease Activity
2 hours post · Minimal
|
2 Participants
|
1 Participants
|
|
Physician Global Assessment of Autoinflammatory Disease Activity
2 hours post · Mild
|
2 Participants
|
1 Participants
|
|
Physician Global Assessment of Autoinflammatory Disease Activity
2 hours post · Moderate
|
0 Participants
|
0 Participants
|
|
Physician Global Assessment of Autoinflammatory Disease Activity
2 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Physician Global Assessment of Autoinflammatory Disease Activity
3 hours post · Absent
|
0 Participants
|
2 Participants
|
|
Physician Global Assessment of Autoinflammatory Disease Activity
3 hours post · Minimal
|
1 Participants
|
1 Participants
|
|
Physician Global Assessment of Autoinflammatory Disease Activity
3 hours post · Mild
|
3 Participants
|
1 Participants
|
|
Physician Global Assessment of Autoinflammatory Disease Activity
3 hours post · Moderate
|
0 Participants
|
0 Participants
|
|
Physician Global Assessment of Autoinflammatory Disease Activity
3 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Physician Global Assessment of Autoinflammatory Disease Activity
5 hours post · Absent
|
0 Participants
|
2 Participants
|
|
Physician Global Assessment of Autoinflammatory Disease Activity
5 hours post · Minimal
|
1 Participants
|
1 Participants
|
|
Physician Global Assessment of Autoinflammatory Disease Activity
5 hours post · Mild
|
3 Participants
|
1 Participants
|
|
Physician Global Assessment of Autoinflammatory Disease Activity
5 hours post · Moderate
|
0 Participants
|
0 Participants
|
|
Physician Global Assessment of Autoinflammatory Disease Activity
5 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Physician Global Assessment of Autoinflammatory Disease Activity
9 hours post · Absent
|
0 Participants
|
1 Participants
|
|
Physician Global Assessment of Autoinflammatory Disease Activity
9 hours post · Minimal
|
1 Participants
|
2 Participants
|
|
Physician Global Assessment of Autoinflammatory Disease Activity
9 hours post · Mild
|
0 Participants
|
1 Participants
|
|
Physician Global Assessment of Autoinflammatory Disease Activity
9 hours post · Moderate
|
3 Participants
|
0 Participants
|
|
Physician Global Assessment of Autoinflammatory Disease Activity
9 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Physician Global Assessment of Autoinflammatory Disease Activity
24 hours post · Absent
|
0 Participants
|
2 Participants
|
|
Physician Global Assessment of Autoinflammatory Disease Activity
24 hours post · Minimal
|
3 Participants
|
2 Participants
|
|
Physician Global Assessment of Autoinflammatory Disease Activity
24 hours post · Mild
|
1 Participants
|
0 Participants
|
|
Physician Global Assessment of Autoinflammatory Disease Activity
24 hours post · Moderate
|
0 Participants
|
0 Participants
|
|
Physician Global Assessment of Autoinflammatory Disease Activity
24 hours post · Severe
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening and Treatment (Day 4): 1 hour pre and 2, 3, 5, 9 and 24 hours post. Scheduled time refers to the time post-meal (screening) and to the time post-dose (treatment). The start of the cold challenge is at 1 hour post and the duration is 45 minutes.Population: The Pharmacodynamic (PD) analysis set included all participants with no protocol deviations with relevant impact on PD data.
The Physician's severity assessment of autoinflammatory disease signs and symptoms is a questionnaire completed by the Investigator. It uses a 5-point scale. Lower scores represent better outcomes. 0 = Absent 1. = Minimal 2. = Mild 3. = Moderate 4. = Severe The following items were assessed: * Assessment of skin disease (urticarial skin rash) * Assessment of arthralgia * Assessment of myalgia * Assessment of headache/migraine * Assessment of conjunctivitis * Assessment of fatigue/malaise
Outcome measures
| Measure |
DFV890 100mg
n=4 Participants
DFV890 100mg oral dose, twice daily for 3 days and one last dose in the morning of Day 4 of the treatment period
|
DFV890 100mg - Treatment
n=4 Participants
DFV890 100mg oral dose, twice daily for 3 days and one last dose in the morning of Day 4 of the treatment period
|
|---|---|---|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Arthralgia 1 hour pre · Minimal
|
1 Participants
|
1 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Conjunctivitis 5 hours post · Mild
|
1 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Conjunctivitis 9 hours post · Moderate
|
1 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Fatigue/Malaise 2 hours post · Minimal
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Headache/Migraine 2 hours post · Mild
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Headache/Migraine 3 hours post · Minimal
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Headache/Migraine 3 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Headache/Migraine 9 hours post · Absent
|
3 Participants
|
4 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Headache/Migraine 9 hours post · Mild
|
1 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Headache/Migraine 9 hours post · Moderate
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Headache/Migraine 9 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Headache/Migraine 24 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Myalgia 1 hour pre · Absent
|
3 Participants
|
4 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Myalgia 1 hour pre · Mild
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Myalgia 2 hours post · Moderate
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Myalgia 2 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Myalgia 3 hours post · Absent
|
3 Participants
|
4 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Myalgia 3 hours post · Minimal
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Myalgia 5 hours post · Mild
|
1 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Myalgia 24 hours post · Minimal
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Myalgia 24 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Skin disease 1 hour pre · Absent
|
0 Participants
|
1 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Skin disease 1 hour pre · Moderate
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Skin disease 1 hour pre · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Skin disease 2 hours post · Absent
|
0 Participants
|
1 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Skin disease 3 hours post · Minimal
|
1 Participants
|
2 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Skin disease 3 hours post · Mild
|
3 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Skin disease 3 hours post · Moderate
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Skin disease 5 hours post · Absent
|
0 Participants
|
2 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Skin disease 5 hours post · Moderate
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Skin disease 9 hours post · Absent
|
0 Participants
|
1 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Skin disease 9 hours post · Minimal
|
1 Participants
|
3 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Skin disease 9 hours post · Mild
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Skin disease 24 hours post · Moderate
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Headache/Migraine 24 hours post · Minimal
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Fatigue/Malaise 1 hour pre · Moderate
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Fatigue/Malaise 1 hour pre · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Fatigue/Malaise 2 hours post · Absent
|
3 Participants
|
3 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Fatigue/Malaise 2 hours post · Mild
|
1 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Fatigue/Malaise 2 hours post · Moderate
|
0 Participants
|
1 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Fatigue/Malaise 2 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Fatigue/Malaise 3 hours post · Absent
|
2 Participants
|
3 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Fatigue/Malaise 3 hours post · Minimal
|
1 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Fatigue/Malaise 3 hours post · Mild
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Fatigue/Malaise 3 hours post · Moderate
|
1 Participants
|
1 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Fatigue/Malaise 3 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Fatigue/Malaise 5 hours post · Absent
|
2 Participants
|
3 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Fatigue/Malaise 5 hours post · Minimal
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Fatigue/Malaise 5 hours post · Mild
|
2 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Fatigue/Malaise 5 hours post · Moderate
|
0 Participants
|
1 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Fatigue/Malaise 5 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Fatigue/Malaise 9 hours post · Absent
|
2 Participants
|
3 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Fatigue/Malaise 9 hours post · Minimal
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Fatigue/Malaise 9 hours post · Mild
|
1 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Fatigue/Malaise 9 hours post · Moderate
|
1 Participants
|
1 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Fatigue/Malaise 9 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Fatigue/Malaise 24 hours post · Absent
|
3 Participants
|
3 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Fatigue/Malaise 24 hours post · Minimal
|
1 Participants
|
1 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Fatigue/Malaise 24 hours post · Mild
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Fatigue/Malaise 24 hours post · Moderate
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Fatigue/Malaise 24 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Headache/Migraine 1 hour pre · Absent
|
4 Participants
|
4 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Headache/Migraine 1 hour pre · Minimal
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Headache/Migraine 1 hour pre · Mild
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Headache/Migraine 1 hour pre · Moderate
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Headache/Migraine 1 hour pre · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Headache/Migraine 2 hours post · Absent
|
4 Participants
|
4 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Headache/Migraine 2 hours post · Minimal
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Headache/Migraine 2 hours post · Moderate
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Headache/Migraine 2 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Headache/Migraine 3 hours post · Absent
|
4 Participants
|
4 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Headache/Migraine 3 hours post · Mild
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Headache/Migraine 3 hours post · Moderate
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Headache/Migraine 5 hours post · Absent
|
4 Participants
|
4 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Headache/Migraine 5 hours post · Minimal
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Headache/Migraine 5 hours post · Mild
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Headache/Migraine 5 hours post · Moderate
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Headache/Migraine 5 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Headache/Migraine 24 hours post · Mild
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Headache/Migraine 9 hours post · Minimal
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Headache/Migraine 24 hours post · Absent
|
4 Participants
|
4 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Headache/Migraine 24 hours post · Moderate
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Myalgia 1 hour pre · Minimal
|
1 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Myalgia 1 hour pre · Moderate
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Myalgia 1 hour pre · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Myalgia 2 hours post · Absent
|
4 Participants
|
3 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Myalgia 2 hours post · Minimal
|
0 Participants
|
1 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Myalgia 2 hours post · Mild
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Myalgia 3 hours post · Mild
|
1 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Myalgia 3 hours post · Moderate
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Myalgia 3 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Myalgia 5 hours post · Absent
|
3 Participants
|
4 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Myalgia 5 hours post · Minimal
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Myalgia 5 hours post · Moderate
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Myalgia 5 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Myalgia 9 hours post · Absent
|
3 Participants
|
4 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Myalgia 9 hours post · Minimal
|
1 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Myalgia 9 hours post · Mild
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Myalgia 9 hours post · Moderate
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Myalgia 9 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Myalgia 24 hours post · Absent
|
4 Participants
|
4 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Myalgia 24 hours post · Mild
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Myalgia 24 hours post · Moderate
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Skin disease 1 hour pre · Minimal
|
3 Participants
|
3 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Skin disease 1 hour pre · Mild
|
1 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Skin disease 2 hours post · Minimal
|
2 Participants
|
3 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Skin disease 2 hours post · Mild
|
2 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Skin disease 2 hours post · Moderate
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Skin disease 2 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Skin disease 3 hours post · Absent
|
0 Participants
|
2 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Skin disease 3 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Skin disease 5 hours post · Minimal
|
1 Participants
|
2 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Skin disease 5 hours post · Mild
|
3 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Skin disease 5 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Conjunctivitis 3 hours post · Moderate
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Conjunctivitis 3 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Arthralgia 1 hour pre · Absent
|
3 Participants
|
3 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Arthralgia 1 hour pre · Mild
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Arthralgia 1 hour pre · Moderate
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Arthralgia 1 hour pre · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Conjunctivitis 5 hours post · Absent
|
3 Participants
|
4 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Arthralgia 2 hours post · Absent
|
4 Participants
|
4 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Arthralgia 2 hours post · Minimal
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Arthralgia 2 hours post · Mild
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Arthralgia 2 hours post · Moderate
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Arthralgia 2 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Arthralgia 3 hours post · Absent
|
4 Participants
|
4 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Arthralgia 3 hours post · Minimal
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Arthralgia 3 hours post · Mild
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Arthralgia 3 hours post · Moderate
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Arthralgia 3 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Arthralgia 5 hours post · Absent
|
3 Participants
|
4 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Arthralgia 5 hours post · Minimal
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Arthralgia 5 hours post · Mild
|
1 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Arthralgia 5 hours post · Moderate
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Arthralgia 5 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Arthralgia 9 hours post · Absent
|
1 Participants
|
3 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Arthralgia 9 hours post · Minimal
|
3 Participants
|
1 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Arthralgia 9 hours post · Mild
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Arthralgia 9 hours post · Moderate
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Arthralgia 9 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Arthralgia 24 hours post · Absent
|
4 Participants
|
3 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Arthralgia 24 hours post · Minimal
|
0 Participants
|
1 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Arthralgia 24 hours post · Mild
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Arthralgia 24 hours post · Moderate
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Arthralgia 24 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Conjunctivitis 1 hour pre · Absent
|
3 Participants
|
3 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Conjunctivitis 1 hour pre · Minimal
|
0 Participants
|
1 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Conjunctivitis 1 hour pre · Mild
|
1 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Conjunctivitis 5 hours post · Minimal
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Conjunctivitis 1 hour pre · Moderate
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Conjunctivitis 1 hour pre · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Conjunctivitis 2 hours post · Absent
|
3 Participants
|
4 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Conjunctivitis 2 hours post · Minimal
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Conjunctivitis 2 hours post · Mild
|
1 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Conjunctivitis 2 hours post · Moderate
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Conjunctivitis 2 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Conjunctivitis 3 hours post · Absent
|
3 Participants
|
4 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Conjunctivitis 3 hours post · Minimal
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Conjunctivitis 3 hours post · Mild
|
1 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Conjunctivitis 5 hours post · Moderate
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Conjunctivitis 5 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Conjunctivitis 9 hours post · Absent
|
2 Participants
|
4 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Conjunctivitis 9 hours post · Minimal
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Conjunctivitis 9 hours post · Mild
|
1 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Conjunctivitis 9 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Conjunctivitis 24 hours post · Absent
|
3 Participants
|
2 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Conjunctivitis 24 hours post · Minimal
|
0 Participants
|
2 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Conjunctivitis 24 hours post · Mild
|
1 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Conjunctivitis 24 hours post · Moderate
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Conjunctivitis 24 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Fatigue/Malaise 1 hour pre · Absent
|
3 Participants
|
3 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Fatigue/Malaise 1 hour pre · Minimal
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Fatigue/Malaise 1 hour pre · Mild
|
1 Participants
|
1 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Skin disease 9 hours post · Moderate
|
3 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Skin disease 9 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Skin disease 24 hours post · Absent
|
0 Participants
|
2 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Skin disease 24 hours post · Minimal
|
3 Participants
|
2 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Skin disease 24 hours post · Mild
|
1 Participants
|
0 Participants
|
|
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
Skin disease 24 hours post · Severe
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening and Treatment (Day 4): 1 hour pre and 2, 3, 5, 9 and 24 hours post. Scheduled time refers to the time post-meal (screening) and to the time post-dose (treatment). The start of the cold challenge is at 1 hour post and the duration is 45 minutes.Population: The Pharmacodynamic (PD) analysis set included all participants with no protocol deviations with relevant impact on PD data.
Patient's global assessment of disease activity is a questionnaire completed by the patient. It uses a 5-point scale. The patient selected a rating based on the patient's current disease activity at the time of the assessment. Lower scores represent better outcomes. 0 = Absent 1. = Minimal 2. = Mild 3. = Moderate 4. = Severe
Outcome measures
| Measure |
DFV890 100mg
n=4 Participants
DFV890 100mg oral dose, twice daily for 3 days and one last dose in the morning of Day 4 of the treatment period
|
DFV890 100mg - Treatment
n=4 Participants
DFV890 100mg oral dose, twice daily for 3 days and one last dose in the morning of Day 4 of the treatment period
|
|---|---|---|
|
Patient's Global Assessment of Disease Activity
1 hour pre · Absent
|
2 Participants
|
3 Participants
|
|
Patient's Global Assessment of Disease Activity
1 hour pre · Mild
|
0 Participants
|
0 Participants
|
|
Patient's Global Assessment of Disease Activity
2 hours post · Mild
|
0 Participants
|
1 Participants
|
|
Patient's Global Assessment of Disease Activity
2 hours post · Moderate
|
0 Participants
|
0 Participants
|
|
Patient's Global Assessment of Disease Activity
2 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Patient's Global Assessment of Disease Activity
1 hour pre · Minimal
|
2 Participants
|
1 Participants
|
|
Patient's Global Assessment of Disease Activity
1 hour pre · Moderate
|
0 Participants
|
0 Participants
|
|
Patient's Global Assessment of Disease Activity
1 hour pre · Severe
|
0 Participants
|
0 Participants
|
|
Patient's Global Assessment of Disease Activity
2 hours post · Absent
|
0 Participants
|
3 Participants
|
|
Patient's Global Assessment of Disease Activity
2 hours post · Minimal
|
4 Participants
|
0 Participants
|
|
Patient's Global Assessment of Disease Activity
3 hours post · Absent
|
0 Participants
|
3 Participants
|
|
Patient's Global Assessment of Disease Activity
3 hours post · Minimal
|
2 Participants
|
0 Participants
|
|
Patient's Global Assessment of Disease Activity
3 hours post · Mild
|
2 Participants
|
1 Participants
|
|
Patient's Global Assessment of Disease Activity
3 hours post · Moderate
|
0 Participants
|
0 Participants
|
|
Patient's Global Assessment of Disease Activity
3 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Patient's Global Assessment of Disease Activity
5 hours post · Absent
|
0 Participants
|
2 Participants
|
|
Patient's Global Assessment of Disease Activity
5 hours post · Minimal
|
2 Participants
|
2 Participants
|
|
Patient's Global Assessment of Disease Activity
5 hours post · Mild
|
2 Participants
|
0 Participants
|
|
Patient's Global Assessment of Disease Activity
5 hours post · Moderate
|
0 Participants
|
0 Participants
|
|
Patient's Global Assessment of Disease Activity
5 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Patient's Global Assessment of Disease Activity
9 hours post · Absent
|
0 Participants
|
2 Participants
|
|
Patient's Global Assessment of Disease Activity
9 hours post · Minimal
|
1 Participants
|
2 Participants
|
|
Patient's Global Assessment of Disease Activity
9 hours post · Mild
|
2 Participants
|
0 Participants
|
|
Patient's Global Assessment of Disease Activity
9 hours post · Moderate
|
1 Participants
|
0 Participants
|
|
Patient's Global Assessment of Disease Activity
9 hours post · Severe
|
0 Participants
|
0 Participants
|
|
Patient's Global Assessment of Disease Activity
24 hours post · Absent
|
1 Participants
|
2 Participants
|
|
Patient's Global Assessment of Disease Activity
24 hours post · Minimal
|
3 Participants
|
2 Participants
|
|
Patient's Global Assessment of Disease Activity
24 hours post · Mild
|
0 Participants
|
0 Participants
|
|
Patient's Global Assessment of Disease Activity
24 hours post · Moderate
|
0 Participants
|
0 Participants
|
|
Patient's Global Assessment of Disease Activity
24 hours post · Severe
|
0 Participants
|
0 Participants
|
Adverse Events
DFV890 100 mg - Treatment
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DFV890 100 mg - Treatment
n=4 participants at risk
DFV890 100mg oral dose, twice daily for 3 days and one last dose in the morning of Day 4 of the treatment period
|
|---|---|
|
General disorders
Asthenia
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 34 days
|
|
General disorders
Chills
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 34 days
|
|
General disorders
Fatigue
|
50.0%
2/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 34 days
|
|
Infections and infestations
Conjunctivitis
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 34 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
75.0%
3/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 34 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 34 days
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 34 days
|
|
Skin and subcutaneous tissue disorders
Cold urticaria
|
50.0%
2/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 34 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 34 days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 34 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 34 days
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
50.0%
2/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 34 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER