Trial Outcomes & Findings for Phase IIa Trial of ALXN1007 for the Treatment of Non-criteria Manifestations of Antiphospholipid Syndrome (NCT NCT02128269)
NCT ID: NCT02128269
Last Updated: 2017-07-13
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Treatment Period (24 weeks)
Results posted on
2017-07-13
Participant Flow
Participant milestones
| Measure |
ALXN1007
ALXN1007 10 mg/kg IV q 2 weeks x 12 doses
|
|---|---|
|
Treatment Period
STARTED
|
9
|
|
Treatment Period
COMPLETED
|
7
|
|
Treatment Period
NOT COMPLETED
|
2
|
|
Follow-up
STARTED
|
9
|
|
Follow-up
COMPLETED
|
9
|
|
Follow-up
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
ALXN1007
ALXN1007 10 mg/kg IV q 2 weeks x 12 doses
|
|---|---|
|
Treatment Period
Adverse Event
|
1
|
|
Treatment Period
Physician Decision
|
1
|
Baseline Characteristics
Phase IIa Trial of ALXN1007 for the Treatment of Non-criteria Manifestations of Antiphospholipid Syndrome
Baseline characteristics by cohort
| Measure |
ALXN1007- Open Label Study
n=9 Participants
ALXN1007
ALXN1007: 10 mg/kg IV q 2 weeks x 12 doses
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
1 participants
n=5 Participants
|
|
Region of Enrollment
France
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Treatment Period (24 weeks)Outcome measures
| Measure |
ALXN1007
n=9 Participants
ALXN1007 10 mg/kg IV q 2 weeks x 12 doses
|
|---|---|
|
Safety and Tolerability of Intravenous (IV) ALXN1007 as Measured by Percentage of Patients Reporting Adverse Events
|
8 Participants
|
Adverse Events
ALXN1007- Open Label Study
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ALXN1007- Open Label Study
n=9 participants at risk
ALXN1007
ALXN1007: 10 mg/kg IV q 2 weeks x 12 doses
|
|---|---|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Hepatobiliary disorders
Cholestasis
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Hepatobiliary disorders
Liver Cytolysis
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
Other adverse events
| Measure |
ALXN1007- Open Label Study
n=9 participants at risk
ALXN1007
ALXN1007: 10 mg/kg IV q 2 weeks x 12 doses
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Blood and lymphatic system disorders
Antiphospholipid syndrome
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Ear and labyrinth disorders
Tinnitus
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Gastrointestinal disorders
Colitis
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Gastrointestinal disorders
Enterocolitis
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Gastrointestinal disorders
Haemorrhoids
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Gastrointestinal disorders
Nausea
|
22.2%
2/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
General disorders
Oedema peripheral
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
General disorders
Pain
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Infections and infestations
Bronchitis
|
22.2%
2/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Infections and infestations
Cystitis
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Infections and infestations
Gastroenteritis
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Infections and infestations
Labyrinthitis
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Infections and infestations
Oral Herpes
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Infections and infestations
Paronychia
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Infections and infestations
Pharyngitis
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Infections and infestations
Sinusitis
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Infections and infestations
Staphylococcal Infection
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Infections and infestations
Tracheitis
|
22.2%
2/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Infections and infestations
Upper respiratory tract infection
|
44.4%
4/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Infections and infestations
Urethritis
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Nervous system disorders
Carpal tunnel syndrome
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Nervous system disorders
Hypoaesthesia
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Nervous system disorders
Restless legs syndrome
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
|
Vascular disorders
Varicose vein
|
11.1%
1/9 • Treatment Period (24 weeks) and Follow-up Period (12 weeks).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication rights are tied to the completion of the multi-center publication
- Publication restrictions are in place
Restriction type: OTHER