Clinical Trial Results:
Placebo-Controlled Proof of Concept Study to Investigate ANB020 Activity upon House Dust Mite Skin Challenge in Patients Suffering from Moderate to Severe Atopic Dermatitis
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Summary
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EudraCT number |
2016-002539-14 |
Trial protocol |
GB |
Global end of trial date |
04 Dec 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
13 Oct 2021
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First version publication date |
13 Oct 2021
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
ANB020-002
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
AnaptysBio Inc.
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Sponsor organisation address |
10421 Pacific Center Court, Suite 200, San Diego, CA, United States, 92121
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Public contact |
AnaptysBio Clinical Trials Info, AnaptysBio Inc, +1 8583626387, clinicaltrialinfo@anaptysbio.com
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Scientific contact |
AnaptysBio Clinical Trials Info, AnaptysBio Inc, +1 8583626387, clinicaltrialinfo@anaptysbio.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
04 Dec 2017
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
04 Dec 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
• To measure the decrease of cytokines within interstitial fluid, where saline and house dust mite (HDM) have been administered, in patients receiving ANB020 compared to placebo.
• To assess the effect of ANB020 on differential white blood cell (WBC) counts.
• To assess the safety and tolerability of single dose administration of ANB020 in patients with atopic dermatitis (AD).
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Protection of trial subjects |
The study was conducted in accordance with the protocol, the ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines, applicable International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines, and applicable laws and regulations.
The study protocol, all study protocol amendments, written study patient information, informed consent form (ICF), Investigator’s Brochure and any other relevant documents were reviewed and approved by an independent ethics committee (IEC) at the study center.
An informed consent document approved by the study center’s IEC was signed by the patient or their legally authorized representative and the authorized person obtaining the informed consent before the participant was entered in the study.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
06 Mar 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 14
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Worldwide total number of subjects |
14
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
14
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||
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Pre-assignment
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Screening details |
A total of 14 (100%) patients were screened in the study. Of these, 12 (85.7%) patients received placebo and ANB020. Two (14.3%) patients discontinued the study prior to ANB020 or placebo administration with the reported reason as patient withdrew consent. | ||||||
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Pre-assignment period milestones
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Number of subjects started |
14 | ||||||
Number of subjects completed |
12 | ||||||
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Pre-assignment subject non-completion reasons
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Reason: Number of subjects |
Consent withdrawn by subject: 2 | ||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
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Arms
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Arm title
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ANB020 | ||||||
Arm description |
Participants received an intravenous (IV) dose of placebo saline on Day 1. On Day 4, participants returned to the study center for a skin challenge test with saline control and house dust mite (HDM) allergen. Approximately 1 hour after the HDM skin challenge, suction blister cups were applied to the site of injection to generate a blister. On Day 8, participants with a positive response to the HDM skin challenge test received 300 mg ANB020 IV. On Day 11 participants returned to the study center for the skin challenge with saline and HDM. Approximately 1 hour after the HDM skin challenge, suction blister cups were applied to the site of injection to generate a blister. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Sterile normal saline (0.9% NaCl) for injection.
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Investigational medicinal product name |
ANB020
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Investigational medicinal product code |
ANB020
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
ANB020 was administered as a single IV dose of 300 mg/100 mL.
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| Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: Two patients discontinued the study prior to ANB020 or placebo administration. |
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Baseline characteristics reporting groups
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Reporting group title |
ANB020
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Reporting group description |
Participants received an intravenous (IV) dose of placebo saline on Day 1. On Day 4, participants returned to the study center for a skin challenge test with saline control and house dust mite (HDM) allergen. Approximately 1 hour after the HDM skin challenge, suction blister cups were applied to the site of injection to generate a blister. On Day 8, participants with a positive response to the HDM skin challenge test received 300 mg ANB020 IV. On Day 11 participants returned to the study center for the skin challenge with saline and HDM. Approximately 1 hour after the HDM skin challenge, suction blister cups were applied to the site of injection to generate a blister. | |||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
ANB020
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Reporting group description |
Participants received an intravenous (IV) dose of placebo saline on Day 1. On Day 4, participants returned to the study center for a skin challenge test with saline control and house dust mite (HDM) allergen. Approximately 1 hour after the HDM skin challenge, suction blister cups were applied to the site of injection to generate a blister. On Day 8, participants with a positive response to the HDM skin challenge test received 300 mg ANB020 IV. On Day 11 participants returned to the study center for the skin challenge with saline and HDM. Approximately 1 hour after the HDM skin challenge, suction blister cups were applied to the site of injection to generate a blister. | ||
Subject analysis set title |
Placebo
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Participants received a placebo IV infusion on Day 1.
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Subject analysis set title |
ANB020
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Participants received 300 mg ANB020 by IV infusion on Day 8.
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End point title |
Interleukin-4 (IL-4) Concentration in Blister Fluid [1] | ||||||||||||||||||
End point description |
Within 24 hours of the saline and HDM skin challenge (Days 5 and 12), blister fluid was aspirated with a 30-gauge needle. Cytokine concentrations were measured using validated assay methods. The lower limit of quantitation (LLOQ) for IL-4 is 6.46 pg/mL.
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End point type |
Primary
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End point timeframe |
Day 5 (4 days after placebo infusion) and Day 12 (4 days after infusion with ANB020)
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Inferential statistical analysis of cytokine concentrations in blister fluid was not performed due to < 5 paired data points. |
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| Notes [2] - All participants had concentrations below lower limit of quantification [3] - All participants had concentrations below lower limit of quantification |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Interleukin-5 (IL-5) Concentration in Blister Fluid [4] | ||||||||||||||||||
End point description |
Within 24 hours of the saline and HDM skin challenge (Days 5 and 12), blister fluid was aspirated with a 30-gauge needle. Cytokine concentrations were measured using validated assay methods. The LLOQ for IL-5 is 1.16 pg/mL.
"99999" indicates values that were below the LLOQ or could not be calculated.
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End point type |
Primary
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End point timeframe |
Day 5 and Day 12
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Inferential statistical analysis of cytokine concentrations in blister fluid was not performed due to < 5 paired data points. |
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| Notes [5] - 4 and 5 subjects had concentrations ≥ LLOQ after saline and HDM challenge, respectively. [6] - 1 and 5 subjects had concentrations ≥ LLOQ after saline and HDM challenge, respectively. |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Interleukin-13 (IL-13) Concentration in Blister Fluid [7] | ||||||||||||||||||
End point description |
Within 24 hours of the saline and HDM skin challenge (Days 5 and 12), blister fluid was aspirated with a 30-gauge needle. Cytokine concentrations were measured using validated assay methods. The LLOQ for IL-13 is 90.96 pg/mL.
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End point type |
Primary
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End point timeframe |
Day 5 and Day 12
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| Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Inferential statistical analysis of cytokine concentrations in blister fluid was not performed due to < 5 paired data points. |
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| Notes [8] - 5 and 6 subjects had concentrations ≥ LLOQ after saline and HDM challenge, respectively. [9] - 6 and 4 subjects had concentrations ≥ LLOQ after saline and HDM challenge, respectively. |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Interleukin-33 (IL-33) Concentration in Blister Fluid [10] | ||||||||||||||||||
End point description |
Within 24 hours of the saline and HDM skin challenge (Days 5 and 12), blister fluid was aspirated with a 30-gauge needle. Cytokine concentrations were measured using validated assay methods. The LLOQ for IL-33 is 4.44 pg/mL.
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End point type |
Primary
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End point timeframe |
Day 5 and Day 12
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| Notes [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Inferential statistical analysis of cytokine concentrations in blister fluid was not performed due to < 5 paired data points. |
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| Notes [11] - All participants had concentrations < LLOQ [12] - All participants had concentrations < LLOQ |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Number of Participants with Treatment-emergent Adverse Events [13] | ||||||||||||||||||||||||||||||||||||
End point description |
Treatment emergent adverse events (TEAEs) are AEs that started or worsened in severity on or after the date and time of the study drug infusion or if the event represents an exacerbation of a condition observed pre-treatment.
A serious AE is any untoward medical occurrence that at any dose:
- Resulted in death;
- Was life-threatening;
- Required inpatient hospitalization or prolongation of existing hospitalization;
- Resulted in persistent or significant disability/incapacity;
- Was a congenital abnormality/birth defect.
- Other: Medically significant events, which did not meet any of the criteria above, but may have jeopardized the patient and may have required medical or surgical intervention to prevent one of the other serious outcomes listed above.
A severe AE is defined as an event that interrupted the patient’s usual daily activity.
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End point type |
Primary
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End point timeframe |
For Placebo, Day 1 to Day 8; For ANB020 from Day 8 to Day 148.
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| Notes [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Inferential statistical analysis of safety data were not planned. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
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End point title |
Longest Wheal Diameter | ||||||||||||||||||
End point description |
Urticarial response (longest wheal diameter) was measured 30 minutes after the HDM skin challenge test.
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End point type |
Secondary
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End point timeframe |
Day 4 (placebo) and Day 11 (ANB020), 30 minutes after the saline and HDM challenge.
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Maximum Observed Concentration (Cmax) of ANB020 | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Day 8 at predose, 0.5 hours after the start of infusion, end of infusion, and 3 hours and 6 hours after the end of infusion.
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| No statistical analyses for this end point | |||||||||
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End point title |
Time to Maximum Observed Concentration (Tmax) of ANB020 | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Day 8 at predose, 0.5 hours after the start of infusion, end of infusion, and 3 hours and 6 hours after the end of infusion.
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| No statistical analyses for this end point | |||||||||
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End point title |
Area Under the Concentration-time Curve in Serum from Time Zero (Predose) Extrapolated to Infinite Time (AUC0-inf) of ANB020 | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Day 8 at predose, 0.5 hours after the start of infusion, end of infusion, and 3 hours and 6 hours after the end of infusion.
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| Notes [14] - Three subjects excluded due to percentage of AUC(0-inf) obtained by extrapolation > 20.0% |
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| No statistical analyses for this end point | |||||||||
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End point title |
Area Under the Serum Concentration-time Curve from Time Zero to the Time of the Last Quantifiable Concentration (AUClast) for ANB020 | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Day 8 at predose, 0.5 hours after the start of infusion, end of infusion, and 3 hours and 6 hours after the end of infusion.
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| No statistical analyses for this end point | |||||||||
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End point title |
Apparent Terminal Half-life (t1/2) of ANB020 | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Day 8 at predose, 0.5 hours after the start of infusion, end of infusion, and 3 hours and 6 hours after the end of infusion.
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| Notes [15] - Two subjects excluded due to a goodness-of-fit statistic for calculation of λZ (Rsq) < 0.800 |
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| No statistical analyses for this end point | |||||||||
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End point title |
Systemic Clearance (CL) of ANB020 | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Day 8 at predose, 0.5 hours after the start of infusion, end of infusion, and 3 hours and 6 hours after the end of infusion.
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| Notes [16] - Three subjects excluded due to percentage of AUC(0-inf) obtained by extrapolation > 20.0% |
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| No statistical analyses for this end point | |||||||||
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End point title |
Volume of Distribution at Steady State Following IV Dosing of ANB020 (Vss) | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Day 8 at predose, 0.5 hours after the start of infusion, end of infusion, and 3 hours and 6 hours after the end of infusion.
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| Notes [17] - Three subjects excluded due to percentage of AUC(0-inf) obtained by extrapolation > 20.0% |
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| No statistical analyses for this end point | |||||||||
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End point title |
Serum IL-4 Concentration | ||||||||||||||||||
End point description |
Cytokine concentrations were measured using validated assay methods. The lower limit of quantitation (LLOQ) for IL-4 is 6.46 pg/mL.
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End point type |
Secondary
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End point timeframe |
Baseline (Day 1 for Placebo and Day 8 for ANB020) and 5 days after study drug administration (Day 5 for placebo and Day 12 for ANB020)
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| Notes [18] - All participants had concentrations below lower limit of quantification [19] - All participants had concentrations below lower limit of quantification |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Serum IL-5 Concentration | ||||||||||||||||||
End point description |
Cytokine concentrations were measured using validated assay methods. The LLOQ for IL-5 is 1.16 pg/mL.
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End point type |
Secondary
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End point timeframe |
Baseline and 5 days after study drug administration
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| Notes [20] - All participants had concentrations less than the LLOQ [21] - All participants had concentrations less than the LLOQ |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Serum IL-13 Concentration | ||||||||||||||||||
End point description |
Cytokine concentrations were measured using validated assay methods. The LLOQ for IL-13 is 90.96 pg/mL.
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End point type |
Secondary
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End point timeframe |
Baseline and 5 days after study drug administration
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| Notes [22] - All participants had concentrations < LLOQ [23] - All participants had concentrations < LLOQ |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Serum IL-33 Concentration | ||||||||||||||||||
End point description |
Cytokine concentrations were measured using validated assay methods. The LLOQ for IL-33 is 4.44 pg/mL.
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End point type |
Secondary
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End point timeframe |
Baseline and 5 days after study drug administration
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| Notes [24] - All participants had concentrations < LLOQ [25] - All participants had concentrations < LLOQ |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Serum Soluble Specific Cell-surface Receptor (sST2) Concentration | ||||||||||||||||||
End point description |
The concentration of sST2 in serum was measured using a quantitative sandwich monoclonal enzyme-linked immunosorbant assay (ELISA). The LLOQ for sST2 was determined to be 3.13 ng/mL.
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End point type |
Secondary
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End point timeframe |
Baseline and 5 days after study drug administration
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Ex-Vivo Induced Interferon-gamma (IFN-y) Levels | ||||||||||||||||||
End point description |
Whole blood samples were stimulated with interleukin-12 and interleukin-33 to determine the affect of ANB020 on inhibition of cytokine-induced interferon gamma. IFN-y concentrations were measured using validated assay methods. The LLOQ of IFN-y was 146.56 ng/L. "99999" indicates values below the LLOQ.
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End point type |
Secondary
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End point timeframe |
Days 1, 11, 64, 120 and 148
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| Notes [26] - The number of subjects with levels ≥ LLOQ was 12, 0, 8, 11, and 11 at each time point respectively |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Number of Participants with Anti-drug Antibodies | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Samples for ADA detection were collected on Days 1, 11, 64, 120, and 148
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| No statistical analyses for this end point | |||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Placebo: Day 1 to Day 8
ANB020: Day 8 to Day 148
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
19.1
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Reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Participants received a placebo IV infusion on Day 1. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
ANB020
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Reporting group description |
Participants received 300 mg ANB020 by IV infusion on Day 8. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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08 Nov 2016 |
Amendment 1 implemented the following changes:
• Secondary objectives updated to include:
o Assess ex vivo PD activity of ANB020 on IFN-γ levels.
o Test for immunogenicity to ANB020.
• Summary of study design updated regarding additional PK draws, PD/ADA, and clinical assessments.
• Schematic of study design updated to reflect the changes in protocol design.
• Schedule of Events was updated to reflect changes in study conduct which includes:
o Update of additional study center visits at Day 85, 120, and 148.
o Additional telephone contact visit at Day 99.
o Additional PK draws on Day 120 and Day 148.
o Whole blood sampling for ex vivo IFN-γ (Day 1, 11, 64, 120 and 148).
o Serum sampling for ADA (Day 1, 11, 64, 120, and 148).
o EASI, IGA, SCORAD, DLQI, 5Ditch, corticosteroid use obtained on Day 85, 120, 148.
o Urinalysis and safety laboratory assessments to Day 85, 120, and 148.
o Moved physical examination and pregnancy test to Day 148 from Day 64.
o Diary checked at Day 85, 99, 120, and 148.
o Concomitant medications/AEs at each new time point.
• Inclusion criteria and Patient restrictions modified to describe methods and duration of contraception for women of childbearing potential and male patients to ensure all patients are using highly effective methods of contraception throughout the study.
• Section 4.3.5 modified to account for EOS to be Day 148 for AEs/SAE follow-up to reflect the changes in study conduct.
• Blinding modified to accurately reflect the study is not blinded and changes in the study conduct.
• Excluded medications modified to include: Any live attenuated vaccine within 4 weeks of screening and for the duration of the study (Day 148) or for 140 days post last dose of study drug.
• Table of blood volume updated.
• Pharmacodynamics, safety analyses, vital signs measurements, physical findings and clinical laboratory evaluation were updated to reflect the changes in study conduct. |
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01 Dec 2016 |
Amendment 2 implemented the following changes:
• HIV criteria were added in the Exclusion criteria and the list of abbreviations was updated.
• Exclusion Criteria was updated with text regarding enrollment of patients with positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV 1 and 2 antibodies at screening to ensure the safety of potential patients that were to be enrolled. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
