Trial Outcomes & Findings for Immunogenicity of Metreleptin in Patients With Generalized Lipodystrophy (NCT NCT04026178)
NCT ID: NCT04026178
Last Updated: 2025-11-26
Results Overview
Anti-metreleptin, anti-human leptin (HuL) binding antidrug antibody (ADA) titers over time. Category of in vitro cell-based neutralizing antibody (NAb) activity to metreleptin, and titer in the receptor blocking (RB) NAb assay in ADA positive samples over time.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
11 participants
Primary outcome timeframe
36 months
Results posted on
2025-11-26
Participant Flow
Patients were recruited from 4 centers in the US. Prescribing Investigators for this study were those who were certified under REMS for MYALEPT prescription and able to ensure prescription of metreleptin was as per the USPI.
At Screening, consenting patients were assessed to ensure that they met eligibility criteria. The informed consent and health insurance portability and accountability act Authorization forms were signed prior to performing any Protocol-required procedures. The assessments conducted at the Screening Visit. When all Screening results were available, individuals were notified of their eligibility status.
Participant milestones
| Measure |
Metreleptin
Subjects will receive prescribed dosage of metreleptin as indicated in the USPI:
Patients (males and females) ≤ 40 kg: 0.06mg/kg Male patients \> 40 kg: 2.5mg Female patients \> 40 kg: 5mg
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
11 GL: 6 Congenital Generalized Lipodystrophy, and 5 Acquired Generalized Lipodystrophy
Baseline characteristics by cohort
| Measure |
Metreleptin
n=11 Participants
Subjects will receive prescribed dosage of metreleptin as indicated in the USPI Patients (males and females) ≤ 40 kg: 0.06mg/kg Male patients \> 40 kg: 2.5mg Female patients \> 40 kg: 5mg
|
|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=492 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=492 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=492 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=492 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=492 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=492 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=492 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=492 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=492 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=492 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=492 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=492 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=492 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=492 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=492 Participants
|
|
Lipodystrophy diagnosis
Congenital Generalised Lipodystrophy
|
6 Participants
n=492 Participants • 11 GL: 6 Congenital Generalized Lipodystrophy, and 5 Acquired Generalized Lipodystrophy
|
|
Lipodystrophy diagnosis
Acquired Generalised Lipodystrophy
|
5 Participants
n=492 Participants • 11 GL: 6 Congenital Generalized Lipodystrophy, and 5 Acquired Generalized Lipodystrophy
|
|
Medical History
Hypertriglyceridemia
|
8 Participants
n=492 Participants
|
|
Medical History
Diabetes
|
7 Participants
n=492 Participants
|
|
Medical History
Pancreatitis
|
5 Participants
n=492 Participants
|
|
Medical History
Hypertension
|
4 Participants
n=492 Participants
|
|
Medical History
Hepatic steatosis
|
3 Participants
n=492 Participants
|
|
Medical History
Polycystic ovary syndrome
|
2 Participants
n=492 Participants
|
|
Medical History
Proteinuric
|
2 Participants
n=492 Participants
|
|
Medical History
Hepatic cirrhosis
|
1 Participants
n=492 Participants
|
PRIMARY outcome
Timeframe: 36 monthsPopulation: Only ADA positive participants were analysed for neutralizing activity.
Anti-metreleptin, anti-human leptin (HuL) binding antidrug antibody (ADA) titers over time. Category of in vitro cell-based neutralizing antibody (NAb) activity to metreleptin, and titer in the receptor blocking (RB) NAb assay in ADA positive samples over time.
Outcome measures
| Measure |
Metreleptin
n=11 Participants
Subjects will receive prescribed dosage of metreleptin as indicated in the USPI:
Patients (males and females) ≤ 40 kg: 0.06mg/kg Male patients \> 40 kg: 2.5mg Female patients \> 40 kg: 5mg
|
|---|---|
|
Evaluate the Immunogenicity Associated With Daily Subcutaneous (SC) Metreleptin Treatment in Patients With Congenital Generalized Lipodystrophy (CGL) or Acquired Generalized Lipodystrophy (AGL).
ADA positive · ADA+
|
10 Participants
|
|
Evaluate the Immunogenicity Associated With Daily Subcutaneous (SC) Metreleptin Treatment in Patients With Congenital Generalized Lipodystrophy (CGL) or Acquired Generalized Lipodystrophy (AGL).
NAb cell based + · ADA+
|
1 Participants
|
|
Evaluate the Immunogenicity Associated With Daily Subcutaneous (SC) Metreleptin Treatment in Patients With Congenital Generalized Lipodystrophy (CGL) or Acquired Generalized Lipodystrophy (AGL).
NAb receptor blocking+ · ADA+
|
10 Participants
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: Only ADA+ participants were analysed for neutralizing activity.
The percent (standard error) of patients with a positive result was compared for the RB NAb assay and the cell-based NAb assay over time.
Outcome measures
| Measure |
Metreleptin
n=10 Participants
Subjects will receive prescribed dosage of metreleptin as indicated in the USPI:
Patients (males and females) ≤ 40 kg: 0.06mg/kg Male patients \> 40 kg: 2.5mg Female patients \> 40 kg: 5mg
|
|---|---|
|
Assess 2 Methods of Measuring in Vitro NAb Activity to Metreleptin.
NAb cell based+
|
1 Participants
|
|
Assess 2 Methods of Measuring in Vitro NAb Activity to Metreleptin.
NAb receptor blocking+
|
10 Participants
|
SECONDARY outcome
Timeframe: 36 monthsSerious adverse events (SAEs), AEs leading to discontinuation, loss of response (as assessed by glycated hemoglobin (HbA1c) and serum triglycerides), severe infections and/or sepsis, standard laboratory tests, and vital signs over time.
Outcome measures
| Measure |
Metreleptin
n=11 Participants
Subjects will receive prescribed dosage of metreleptin as indicated in the USPI:
Patients (males and females) ≤ 40 kg: 0.06mg/kg Male patients \> 40 kg: 2.5mg Female patients \> 40 kg: 5mg
|
|---|---|
|
Evaluate the Safety and Tolerability in Relation to the Development of or Absence of Anti-metreleptin and Anti-HuL Binding ADAs, and/or in Vitro NAb Activity to Metreleptin in Patients With CGL or AGL
All AE · AEs leading to discomntinuation
|
11 Participants
|
|
Evaluate the Safety and Tolerability in Relation to the Development of or Absence of Anti-metreleptin and Anti-HuL Binding ADAs, and/or in Vitro NAb Activity to Metreleptin in Patients With CGL or AGL
SAE · AEs leading to discomntinuation
|
7 Participants
|
|
Evaluate the Safety and Tolerability in Relation to the Development of or Absence of Anti-metreleptin and Anti-HuL Binding ADAs, and/or in Vitro NAb Activity to Metreleptin in Patients With CGL or AGL
AEs leading to discontinuation · AEs leading to discomntinuation
|
1 Participants
|
|
Evaluate the Safety and Tolerability in Relation to the Development of or Absence of Anti-metreleptin and Anti-HuL Binding ADAs, and/or in Vitro NAb Activity to Metreleptin in Patients With CGL or AGL
Severe infections and/or sepsis · AEs leading to discomntinuation
|
2 Participants
|
|
Evaluate the Safety and Tolerability in Relation to the Development of or Absence of Anti-metreleptin and Anti-HuL Binding ADAs, and/or in Vitro NAb Activity to Metreleptin in Patients With CGL or AGL
Blood Triglycerides increased · AEs leading to discomntinuation
|
3 Participants
|
|
Evaluate the Safety and Tolerability in Relation to the Development of or Absence of Anti-metreleptin and Anti-HuL Binding ADAs, and/or in Vitro NAb Activity to Metreleptin in Patients With CGL or AGL
Glycosylated haemoglobin increased · AEs leading to discomntinuation
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 36 monthsPopulation: Only subjects who reached the visits (Month 12, 24 ,36) were included in the analysis
Change from Baseline in HbA1c over time.
Outcome measures
| Measure |
Metreleptin
n=11 Participants
Subjects will receive prescribed dosage of metreleptin as indicated in the USPI:
Patients (males and females) ≤ 40 kg: 0.06mg/kg Male patients \> 40 kg: 2.5mg Female patients \> 40 kg: 5mg
|
|---|---|
|
Evaluate the Efficacy With Daily Metreleptin in Patients With GL
Absolute change in HbA1c from baseline to Month 12
|
-0.3 Percentage
Interval -6.5 to 2.3
|
|
Evaluate the Efficacy With Daily Metreleptin in Patients With GL
Absolute change in HbA1c from baseline to Month 24
|
-0.5 Percentage
Interval -7.2 to 1.8
|
|
Evaluate the Efficacy With Daily Metreleptin in Patients With GL
Absolute change in HbA1c from baseline to Month 36
|
-0.7 Percentage
Interval -7.3 to 1.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 36 monthsPopulation: Only subjects who reached the visits (Month 12, 24 ,36) were included in the analysis
Percent change from Baseline in fasting triglycerides over time.
Outcome measures
| Measure |
Metreleptin
n=11 Participants
Subjects will receive prescribed dosage of metreleptin as indicated in the USPI:
Patients (males and females) ≤ 40 kg: 0.06mg/kg Male patients \> 40 kg: 2.5mg Female patients \> 40 kg: 5mg
|
|---|---|
|
Evaluate the Efficacy With Daily Metreleptin in Patients With GL
Precent change in triglycerides from baseline to Month 12
|
-49.68 Percent Change
Interval -91.26 to 174.77
|
|
Evaluate the Efficacy With Daily Metreleptin in Patients With GL
Precent change in triglycerides from baseline to Month 24
|
-46.72 Percent Change
Interval -92.25 to 593.01
|
|
Evaluate the Efficacy With Daily Metreleptin in Patients With GL
Precent change in triglycerides from baseline to Month 36
|
-58.12 Percent Change
Interval -98.55 to -22.16
|
Adverse Events
Metreleptin
Serious events: 7 serious events
Other events: 11 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Metreleptin
n=11 participants at risk
Subjects will receive prescribed dosage of metreleptin as indicated in the USPI:
Patients (males and females) ≤ 40 kg: 0.06mg/kg Male patients \> 40 kg: 2.5mg Female patients \> 40 kg: 5mg
|
|---|---|
|
Infections and infestations
COVID-19
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Gastrointestinal disorders
Pancreatitis relapsing
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Infections and infestations
Osteomyelitis
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Infections and infestations
Sepsis
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Gastrointestinal disorders
Constipation
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
Other adverse events
| Measure |
Metreleptin
n=11 participants at risk
Subjects will receive prescribed dosage of metreleptin as indicated in the USPI:
Patients (males and females) ≤ 40 kg: 0.06mg/kg Male patients \> 40 kg: 2.5mg Female patients \> 40 kg: 5mg
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Cardiac disorders
Cardiac failure
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Ear and labyrinth disorders
Cerumen impaction
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Eye disorders
Cataract
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Gastrointestinal disorders
Abdominal pain
|
27.3%
3/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
General disorders
Diarrhea
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
General disorders
Injection site haemorrhage
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
General disorders
Peripheral swelling
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Hepatobiliary disorders
Ocular icterus
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Infections and infestations
Bacterial vaginosis
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Infections and infestations
Chlamydial infection
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Infections and infestations
COVID-19
|
36.4%
4/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Infections and infestations
Croup infectious
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Infections and infestations
Infectious mononucleosis
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Infections and infestations
Influenza
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Infections and infestations
Respiratory syncytial virus infection
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Infections and infestations
Sinusitis
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Infections and infestations
Tonsilitis
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Infections and infestations
Urinary tract infection
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Infections and infestations
Viral infection
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Injury, poisoning and procedural complications
Fall
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Injury, poisoning and procedural complications
Foot fracture
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Injury, poisoning and procedural complications
Hand fracture
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Injury, poisoning and procedural complications
Maternal exposure during pregnancy
|
18.2%
2/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Injury, poisoning and procedural complications
Skin laceration
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Investigations
Blood bilirubin increased
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Investigations
Blood cholesterol increased
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Investigations
Blood pressure increased
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Investigations
Blood triglycerides increased
|
18.2%
2/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Investigations
Glycosylated haemoglobin increased
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Investigations
Liver function test increased
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Nervous system disorders
Hypoesthesia
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Nervous system disorders
Motor dysfunction
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Nervous system disorders
Neuropathy peripheral
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Psychiatric disorders
Anxiety
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Psychiatric disorders
Insomnia
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Psychiatric disorders
Mental status changes
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Psychiatric disorders
Stress
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Renal and urinary disorders
Acute kidney injury
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Renal and urinary disorders
Focal segmental glomerulosclerosis
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Renal and urinary disorders
Bladder spasm
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Renal and urinary disorders
Renal impairment
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Skin and subcutaneous tissue disorders
Eczema
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Skin and subcutaneous tissue disorders
Xanthoma
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Surgical and medical procedures
Abortion induced
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
|
|
Vascular disorders
Arteriovenous fistula
|
9.1%
1/11 • From signing the ICF up until either the last scheduled Follow-up Visit (36 months) or at least 4 weeks after the last dose of study medication in the case of an early termination
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place