Trial Outcomes & Findings for IdeS in Asymptomatic Antibody-Mediated Thrombotic Thrombocytopenic Purpura (TTP) Patients (NCT NCT02854059)

NCT ID: NCT02854059

Last Updated: 2019-09-13

Results Overview

Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent AE (TEAE) is defined as any AE occurring after administration of the IMP and within the time of the residual drug effect period (i.e. 30 days after IMP administration). AEs reported in ClinicalTrials.gov include TEAEs and post-treatment AEs, i.e. all AEs occurring after administration of IdeS until end of study. Please refer to Adverse Event section for details on reported AEs

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: From dosing until end of follow up on day 64
• Results posted on: 2019-09-13

Participant Flow

Participant milestones

Measure	Treatment IdeS (0.25 mg/kg) A single 30 minutes i.v. infusion of IdeS (0.25 mg/kg). Following an evaluation of safety and efficacy in 3 patients receiving 0.25 mg/kg there will be a potential to increase the IdeS dose to 0.5 mg/kg for the remaining 3 patients.	IdeS (0.50 mg/kg) A single 30 minutes i.v. infusion of IdeS (0.50 mg/kg).
Overall Study STARTED	2	0
Overall Study COMPLETED	2	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

IdeS in Asymptomatic Antibody-Mediated Thrombotic Thrombocytopenic Purpura (TTP) Patients

Baseline characteristics by cohort

Measure	Treatment IdeS (0.25 mg/kg) n=2 Participants A single 30 minutes i.v. infusion of IdeS (0.25 mg/kg). Following an evaluation of safety and efficacy in 3 patients receiving 0.25 mg/kg there will be a potential to increase the IdeS dose to 0.5 mg/kg for the remaining 3 patients.	Treatment IdeS (0.50 mg/kg) A single 30 minutes i.v. infusion of IdeS (0.50 mg/kg).	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	—	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Region of Enrollment United Kingdom	2 participants n=5 Participants	—	2 participants n=5 Participants

PRIMARY outcome

Timeframe: From dosing until end of follow up on day 64

Population: Because of the premature termination of the study due to the non-favourable risk-benefit profile in the first 2 patients and since the sponsor will no longer pursue the indication, the analyses as described in the protocol were not performed. Instead, data collected for the 2 enrolled subjects were listed and/or presented graphically.

Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation.

A treatment emergent AE (TEAE) is defined as any AE occurring after administration of the IMP and within the time of the residual drug effect period (i.e. 30 days after IMP administration).

AEs reported in ClinicalTrials.gov include TEAEs and post-treatment AEs, i.e. all AEs occurring after administration of IdeS until end of study.

Please refer to Adverse Event section for details on reported AEs

Outcome measures

Measure	Treatment IdeS (0.25 mg/kg) n=2 Participants A single 30 minutes i.v. infusion of IdeS (0.25 mg/kg). Following an evaluation of safety and efficacy in 3 patients receiving 0.25 mg/kg there will be a potential to increase the IdeS dose to 0.5 mg/kg for the remaining 3 patients.	Treatment IdeS (0.50 mg/kg) A single 30 minutes i.v. infusion of IdeS (0.50 mg/kg).
Safety and Tolerability as Measured by Type, Frequency and Intensity of Adverse Events TEAEs	10 Adverse Events	—
Safety and Tolerability as Measured by Type, Frequency and Intensity of Adverse Events Mild TEAEs (Grade=1)	7 Adverse Events	—
Safety and Tolerability as Measured by Type, Frequency and Intensity of Adverse Events Moderate TEAEs (Grade=2)	1 Adverse Events	—
Safety and Tolerability as Measured by Type, Frequency and Intensity of Adverse Events Severe TEAEs (Grade=3)	1 Adverse Events	—
Safety and Tolerability as Measured by Type, Frequency and Intensity of Adverse Events Life threatening TEAEs (Grade=4)	1 Adverse Events	—
Safety and Tolerability as Measured by Type, Frequency and Intensity of Adverse Events Related TEAEs	4 Adverse Events	—
Safety and Tolerability as Measured by Type, Frequency and Intensity of Adverse Events Serious TEAEs	2 Adverse Events	—
Safety and Tolerability as Measured by Type, Frequency and Intensity of Adverse Events Post-TEAEs	2 Adverse Events	—
Safety and Tolerability as Measured by Type, Frequency and Intensity of Adverse Events Mild Post-TEAEs (Grade=1)	1 Adverse Events	—
Safety and Tolerability as Measured by Type, Frequency and Intensity of Adverse Events Moderate Post-TEAEs (Grade=2)	1 Adverse Events	—
Safety and Tolerability as Measured by Type, Frequency and Intensity of Adverse Events Related Post-TEAEs	0 Adverse Events	—
Safety and Tolerability as Measured by Type, Frequency and Intensity of Adverse Events Serious Post-TEAEs	2 Adverse Events	—

SECONDARY outcome

Timeframe: From day of dosing until end of follow up on day 64

Population: Because of the premature termination of the study due to the non-favourable risk-benefit profile in the first 2 patients and since the sponsor will no longer pursue the indication, the analyses as described in the protocol were not performed. Instead, data collected for the 2 enrolled subjects were listed and/or presented graphically.

ADAMTS13 is an enzyme which is inhibited in patients with TTP. The efficacy of IdeS on ADAMTS13 activity was measured througout the study as change from baseline.

Outcome measures

Measure	Treatment IdeS (0.25 mg/kg) n=2 Participants A single 30 minutes i.v. infusion of IdeS (0.25 mg/kg). Following an evaluation of safety and efficacy in 3 patients receiving 0.25 mg/kg there will be a potential to increase the IdeS dose to 0.5 mg/kg for the remaining 3 patients.	Treatment IdeS (0.50 mg/kg) A single 30 minutes i.v. infusion of IdeS (0.50 mg/kg).
Number of Patients With Change From Baseline in ADAMTS13 Activity Change in ADAMTS13 at any timepoint after IdeS	0 Participants	—
Number of Patients With Change From Baseline in ADAMTS13 Activity No change in ADAMTS13 at any time after IdeS	2 Participants	—

SECONDARY outcome

Timeframe: From day of dosing until end of follow up on day 64

Population: Because of the premature termination of the study due to the non-favourable risk-benefit profile in the first 2 patients and since the sponsor will no longer pursue the indication, the analyses as described in the protocol were not performed. Instead, data collected for the 2 enrolled subjects were listed and/or presented graphically.

The efficacy of IdeS on ADAMTS13 antibody cleaving was measured througout the study as change from baseline in ADAMTS13 antibody concentration.

Outcome measures

Measure	Treatment IdeS (0.25 mg/kg) n=2 Participants A single 30 minutes i.v. infusion of IdeS (0.25 mg/kg). Following an evaluation of safety and efficacy in 3 patients receiving 0.25 mg/kg there will be a potential to increase the IdeS dose to 0.5 mg/kg for the remaining 3 patients.	Treatment IdeS (0.50 mg/kg) A single 30 minutes i.v. infusion of IdeS (0.50 mg/kg).
Number of Patients With Change From Baseline in ADAMTS13 Antibody Levels ≥90% decrease in antibodies 2-24h after IdeS	2 Participants	—
Number of Patients With Change From Baseline in ADAMTS13 Antibody Levels <90% decrease in antibodies 2-24h after IdeS	0 Participants	—

SECONDARY outcome

Timeframe: From day of dosing until end of follow up on day 64

Population: Because of the premature termination of the study due to the non-favourable risk-benefit profile in the first 2 patients and since the sponsor will no longer pursue the indication, the analyses as described in the protocol were not performed. Instead, data collected for the 2 enrolled subjects were listed and/or presented graphically.

The ADAMTS13 activity in TTP patients is decreased. The efficacy of IdeS on ADAMTS13 activity was assessed throughout the study to identify the time-point of return to normal levels.

Outcome measures

Measure	Treatment IdeS (0.25 mg/kg) n=2 Participants A single 30 minutes i.v. infusion of IdeS (0.25 mg/kg). Following an evaluation of safety and efficacy in 3 patients receiving 0.25 mg/kg there will be a potential to increase the IdeS dose to 0.5 mg/kg for the remaining 3 patients.	Treatment IdeS (0.50 mg/kg) A single 30 minutes i.v. infusion of IdeS (0.50 mg/kg).
Number of Patients for Whom a Decreased ADAMTS13 Activity Returned to Normal Levels at Different Time-points in the Study Normal ADAMTS13 activity any time after IdeS	0 Participants	—
Number of Patients for Whom a Decreased ADAMTS13 Activity Returned to Normal Levels at Different Time-points in the Study Decreased ADAMTS13 activity all time after IdeS	2 Participants	—

SECONDARY outcome

Timeframe: From day of dosing until end of follow up on day 64

Population: Because of the premature termination of the study due to the non-favourable risk-benefit profile in the first 2 patients and since the sponsor will no longer pursue the indication, the analyses as described in the protocol were not performed. Instead, data collected for the 2 enrolled subjects were listed and/or presented graphically.

IdeS cleaves IgG molecules. The concentration of uncleaved IgG in the patient's serum was measured throughout the study to determine change from baseline following IdeS administration.

Outcome measures

Measure	Treatment IdeS (0.25 mg/kg) n=2 Participants A single 30 minutes i.v. infusion of IdeS (0.25 mg/kg). Following an evaluation of safety and efficacy in 3 patients receiving 0.25 mg/kg there will be a potential to increase the IdeS dose to 0.5 mg/kg for the remaining 3 patients.	Treatment IdeS (0.50 mg/kg) A single 30 minutes i.v. infusion of IdeS (0.50 mg/kg).
Number of Patients With Change From Baseline in Pharmacodynamics as Measured by Level of IgG ≥90% decrease in IgG 2-24h after IdeS	2 Participants	—
Number of Patients With Change From Baseline in Pharmacodynamics as Measured by Level of IgG ≥90% decrease in IgG 3 days after IdeS	1 Participants	—
Number of Patients With Change From Baseline in Pharmacodynamics as Measured by Level of IgG ≥90% decrease in IgG 7-64 days after IdeS	0 Participants	—

SECONDARY outcome

Timeframe: From day of dosing until end of follow up on day 64

Population: Because of the premature termination of the study due to the non-favourable risk-benefit profile in the first 2 patients and since the sponsor will no longer pursue the indication, the analyses as described in the protocol were not performed. Instead, data collected for the 2 enrolled subjects were listed and/or presented graphically.

Most humans have been infected with S. pyogenes which is the origin of IdeS. It was therefore expected that patients in this study might have antibodies against IdeS before being exposed to IdeS in the study. The concentration of ant-IdeS antibodies was measured before dosing and throughout the study.

Outcome measures

Measure	Treatment IdeS (0.25 mg/kg) n=2 Participants A single 30 minutes i.v. infusion of IdeS (0.25 mg/kg). Following an evaluation of safety and efficacy in 3 patients receiving 0.25 mg/kg there will be a potential to increase the IdeS dose to 0.5 mg/kg for the remaining 3 patients.	Treatment IdeS (0.50 mg/kg) A single 30 minutes i.v. infusion of IdeS (0.50 mg/kg).
Number of Patients Showing IdeS Immunogenicity as Measured by Anti-drug Antibodies Presence of anti-IdeS antibodies before IdeS	2 Participants	—
Number of Patients Showing IdeS Immunogenicity as Measured by Anti-drug Antibodies Elevated anti-IdeS antibodies Day 64	2 Participants	—

SECONDARY outcome

Timeframe: From day of dosing until day 14

Population: Because of the premature termination of the study due to the non-favourable risk-benefit profile in the first 2 patients and since the sponsor will no longer pursue the indication, the analyses as described in the protocol were not performed. Instead, data collected for the 2 enrolled subjects were listed and presented graphically.

The concentration of IdeS in serum was measured to identify the pharmacokinetic parameter Cmax of IdeS in TTP patients.

Outcome measures

Measure	Treatment IdeS (0.25 mg/kg) n=2 Participants A single 30 minutes i.v. infusion of IdeS (0.25 mg/kg). Following an evaluation of safety and efficacy in 3 patients receiving 0.25 mg/kg there will be a potential to increase the IdeS dose to 0.5 mg/kg for the remaining 3 patients.	Treatment IdeS (0.50 mg/kg) A single 30 minutes i.v. infusion of IdeS (0.50 mg/kg).
Maximum Serum Concentration (Cmax) of IdeS	6.64 µg/mL Interval 4.6 to 8.67	—

SECONDARY outcome

Timeframe: From day of dosing until day 14

Population: Because of the premature termination of the study due to the non-favourable risk-benefit profile in the first 2 patients and since the sponsor will no longer pursue the indication, the analyses as described in the protocol were not performed. Instead, data collected for the 2 enrolled subjects were listed and presented graphically.

The concentration of IdeS in serum was measured to identify the pharmacokinetic parameter Tmax of IdeS in TTP patients. Tmax refers to the time-point when the serum concentration of IdeS reaches maximum.

Outcome measures

Measure	Treatment IdeS (0.25 mg/kg) n=2 Participants A single 30 minutes i.v. infusion of IdeS (0.25 mg/kg). Following an evaluation of safety and efficacy in 3 patients receiving 0.25 mg/kg there will be a potential to increase the IdeS dose to 0.5 mg/kg for the remaining 3 patients.	Treatment IdeS (0.50 mg/kg) A single 30 minutes i.v. infusion of IdeS (0.50 mg/kg).
Time-point for Maximum Serum Concentration of IdeS	1.38 hours Interval 0.75 to 2.0	—

SECONDARY outcome

Timeframe: From day of dosing until end of follow up on day 64

Population: The concentration of F(ab')2 fragments in the patients' serum samples was not analysed because of the premature termination of the study due to the non-favourable risk-benefit profile in the first 2 patients and since the sponsor will no longer pursue the indication.

The efficacy of IdeS can be measured as change from baseline in F(ab')2 fragments (i.e. the antigen binding fragment of IgG).

Outcome measures

Outcome data not reported

Adverse Events

Treatment IdeS (0.25 mg/kg)

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Treatment IdeS (0.50 mg/kg)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment IdeS (0.25 mg/kg) n=2 participants at risk A single 30 minutes i.v. infusion of IdeS (0.25 mg/kg). Following an evaluation of safety and efficacy in 3 patients receiving 0.25 mg/kg there will be a potential to increase the IdeS dose to 0.5 mg/kg for the remaining 3 patients.	Treatment IdeS (0.50 mg/kg) A single 30 minutes i.v. infusion of IdeS (0.50 mg/kg).
Immune system disorders Serum sickness	100.0% 2/2 • Number of events 2 • Adverse events (AEs) were collected for a time-period of 3 months for the individual subject (i.e. from the subject signed the informed consent form (ICF) throughout the study including the follow-up period until the end of study visit). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent AE (TEAE) was defined as any AE occurring after administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IdeS administration). AEs reported in ClinicalTrials.gov include TEAEs and post-TEAEs, i.e. all AEs occurring after administration of IdeS until end of study	— 0/0 • Adverse events (AEs) were collected for a time-period of 3 months for the individual subject (i.e. from the subject signed the informed consent form (ICF) throughout the study including the follow-up period until the end of study visit). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent AE (TEAE) was defined as any AE occurring after administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IdeS administration). AEs reported in ClinicalTrials.gov include TEAEs and post-TEAEs, i.e. all AEs occurring after administration of IdeS until end of study
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	50.0% 1/2 • Number of events 1 • Adverse events (AEs) were collected for a time-period of 3 months for the individual subject (i.e. from the subject signed the informed consent form (ICF) throughout the study including the follow-up period until the end of study visit). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent AE (TEAE) was defined as any AE occurring after administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IdeS administration). AEs reported in ClinicalTrials.gov include TEAEs and post-TEAEs, i.e. all AEs occurring after administration of IdeS until end of study	— 0/0 • Adverse events (AEs) were collected for a time-period of 3 months for the individual subject (i.e. from the subject signed the informed consent form (ICF) throughout the study including the follow-up period until the end of study visit). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent AE (TEAE) was defined as any AE occurring after administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IdeS administration). AEs reported in ClinicalTrials.gov include TEAEs and post-TEAEs, i.e. all AEs occurring after administration of IdeS until end of study

Other adverse events

Measure	Treatment IdeS (0.25 mg/kg) n=2 participants at risk A single 30 minutes i.v. infusion of IdeS (0.25 mg/kg). Following an evaluation of safety and efficacy in 3 patients receiving 0.25 mg/kg there will be a potential to increase the IdeS dose to 0.5 mg/kg for the remaining 3 patients.	Treatment IdeS (0.50 mg/kg) A single 30 minutes i.v. infusion of IdeS (0.50 mg/kg).
Gastrointestinal disorders Dry mouth	50.0% 1/2 • Number of events 1 • Adverse events (AEs) were collected for a time-period of 3 months for the individual subject (i.e. from the subject signed the informed consent form (ICF) throughout the study including the follow-up period until the end of study visit). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent AE (TEAE) was defined as any AE occurring after administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IdeS administration). AEs reported in ClinicalTrials.gov include TEAEs and post-TEAEs, i.e. all AEs occurring after administration of IdeS until end of study	— 0/0 • Adverse events (AEs) were collected for a time-period of 3 months for the individual subject (i.e. from the subject signed the informed consent form (ICF) throughout the study including the follow-up period until the end of study visit). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent AE (TEAE) was defined as any AE occurring after administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IdeS administration). AEs reported in ClinicalTrials.gov include TEAEs and post-TEAEs, i.e. all AEs occurring after administration of IdeS until end of study
General disorders Pyrexia	50.0% 1/2 • Number of events 2 • Adverse events (AEs) were collected for a time-period of 3 months for the individual subject (i.e. from the subject signed the informed consent form (ICF) throughout the study including the follow-up period until the end of study visit). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent AE (TEAE) was defined as any AE occurring after administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IdeS administration). AEs reported in ClinicalTrials.gov include TEAEs and post-TEAEs, i.e. all AEs occurring after administration of IdeS until end of study	— 0/0 • Adverse events (AEs) were collected for a time-period of 3 months for the individual subject (i.e. from the subject signed the informed consent form (ICF) throughout the study including the follow-up period until the end of study visit). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent AE (TEAE) was defined as any AE occurring after administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IdeS administration). AEs reported in ClinicalTrials.gov include TEAEs and post-TEAEs, i.e. all AEs occurring after administration of IdeS until end of study
Musculoskeletal and connective tissue disorders Arthralgia	100.0% 2/2 • Number of events 2 • Adverse events (AEs) were collected for a time-period of 3 months for the individual subject (i.e. from the subject signed the informed consent form (ICF) throughout the study including the follow-up period until the end of study visit). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent AE (TEAE) was defined as any AE occurring after administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IdeS administration). AEs reported in ClinicalTrials.gov include TEAEs and post-TEAEs, i.e. all AEs occurring after administration of IdeS until end of study	— 0/0 • Adverse events (AEs) were collected for a time-period of 3 months for the individual subject (i.e. from the subject signed the informed consent form (ICF) throughout the study including the follow-up period until the end of study visit). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent AE (TEAE) was defined as any AE occurring after administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IdeS administration). AEs reported in ClinicalTrials.gov include TEAEs and post-TEAEs, i.e. all AEs occurring after administration of IdeS until end of study
Nervous system disorders Headache	50.0% 1/2 • Number of events 1 • Adverse events (AEs) were collected for a time-period of 3 months for the individual subject (i.e. from the subject signed the informed consent form (ICF) throughout the study including the follow-up period until the end of study visit). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent AE (TEAE) was defined as any AE occurring after administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IdeS administration). AEs reported in ClinicalTrials.gov include TEAEs and post-TEAEs, i.e. all AEs occurring after administration of IdeS until end of study	— 0/0 • Adverse events (AEs) were collected for a time-period of 3 months for the individual subject (i.e. from the subject signed the informed consent form (ICF) throughout the study including the follow-up period until the end of study visit). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent AE (TEAE) was defined as any AE occurring after administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IdeS administration). AEs reported in ClinicalTrials.gov include TEAEs and post-TEAEs, i.e. all AEs occurring after administration of IdeS until end of study
Skin and subcutaneous tissue disorders Rash	100.0% 2/2 • Number of events 2 • Adverse events (AEs) were collected for a time-period of 3 months for the individual subject (i.e. from the subject signed the informed consent form (ICF) throughout the study including the follow-up period until the end of study visit). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent AE (TEAE) was defined as any AE occurring after administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IdeS administration). AEs reported in ClinicalTrials.gov include TEAEs and post-TEAEs, i.e. all AEs occurring after administration of IdeS until end of study	— 0/0 • Adverse events (AEs) were collected for a time-period of 3 months for the individual subject (i.e. from the subject signed the informed consent form (ICF) throughout the study including the follow-up period until the end of study visit). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent AE (TEAE) was defined as any AE occurring after administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IdeS administration). AEs reported in ClinicalTrials.gov include TEAEs and post-TEAEs, i.e. all AEs occurring after administration of IdeS until end of study
Cardiac disorders Tachycardia	50.0% 1/2 • Number of events 1 • Adverse events (AEs) were collected for a time-period of 3 months for the individual subject (i.e. from the subject signed the informed consent form (ICF) throughout the study including the follow-up period until the end of study visit). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent AE (TEAE) was defined as any AE occurring after administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IdeS administration). AEs reported in ClinicalTrials.gov include TEAEs and post-TEAEs, i.e. all AEs occurring after administration of IdeS until end of study	— 0/0 • Adverse events (AEs) were collected for a time-period of 3 months for the individual subject (i.e. from the subject signed the informed consent form (ICF) throughout the study including the follow-up period until the end of study visit). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent AE (TEAE) was defined as any AE occurring after administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IdeS administration). AEs reported in ClinicalTrials.gov include TEAEs and post-TEAEs, i.e. all AEs occurring after administration of IdeS until end of study

Additional Information

Elisabeth Sonesson (Director Clinical Operations)

Hansa Biopharma AB

Phone: +46 (0)708 54 86 46

Email: elisabeth.sonesson@hansabiopharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee All MS must be sent to Sponsor for review at least 60d before submission. Sponsor may request changes. All reasonable comments will be incorporated by Investigator. If MS contains info that could impact proprietary or IP interests, the Sponsor is entitled to request a 6 mth publication delay, allowing actions to protect its interests. The Investigator/Trust shall not unreasonably withhold or delay its consent to such request from the Sponsor or for an exceptional additional delay if requested.
• Publication restrictions are in place

Restriction type: OTHER