FAsenra Safety Trial in India - FAST

Study identifier:D3250C00093

ClinicalTrials.gov identifier:NCT05384938

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Postmarketing, Phase 4, Multicentre, Prospective, Single-arm Study to Assess the Safety of Fasenra® (Benralizumab) in Adult Patients of Severe Asthma with Eosinophilic Phenotype in India.

Medical condition

In Adult Patients of Severe Asthma with Eosinophilic Phenotype in India

Phase

Phase 4

Healthy volunteers

Study drug

Sex

All

Actual Enrollment

139

Study type

Interventional

Age

18 Years - 75 Years

Date

Study Start Date: 19 Nov 2021

Primary Completion Date: 01 Jul 2023

Study Completion Date: 01 Jul 2023

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2024 by AstraZeneca

Collaborators

Not Applicable

Inclusion and exclusion criteria

Inclusion Criteria

1. Male or female patients 18 to 75 years of age inclusive, at the time of signing the informed consent
2. Patients with physician’s confirmed diagnosis of severe asthma with an eosinophilic phenotype, ie, a diagnosis of severe asthma in preceding at least 12 months, with an eosinophil count of ≥300 cells/μL at screening, requiring treatment with high-dose ICS (>500 μg fluticasone propionate dry powder formulation, or >800 μg budesonide dry powder formulation, or equivalent total daily dose) and a LABA as maintenance treatment for at least 3 months prior to enrolment
3. A decreased lung function with prebronchodilator (Pre-BD) forced expiratory volume in 1 second (FEV1) of <80% predicted, demonstrated by spirometry at screening
4. At least 2 documented asthma exacerbations in the preceeding12 months, except in 30 days before the date of informed consent, that required the use of a systemic corticosteroid or temporary increase from the patient’s usual maintenance dose of oral corticosteroid (OCS)
5. Documented postbronchodilator (post-BD) reversibility in FEV1 of ≥12% and ≥200 mL in FEV1 within 12 months before first dose. If historical documentation is not available, reversibility must be demonstrated and documented at screening or Day 1 before first dose
6. Benralizumab naïve patients who have not previously received benralizumab prior to the start of this study
7. Patients who are willing and capable of giving signed informed consent as described in Appendix A, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria

1. Clinically important pulmonary disease other than asthma (eg, active lung infection, chronic obstructive pulmonary disease, bronchiectasis, pulmonary fibrosis, cystic fibrosis etc.) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome), which can confound the outcome assessment.
2. Patients currently enrolled in an interventional clinical study in parallel including those with any biologic treatment
3. Patients who have received any biologic within 30 days prior to the date of informed consent.
4. Known history of allergy or reaction to the benralizumab formulation or excipients (L-histidine, L-histidine hydrochloride monohydrate, α-trehalose dihydrate, polysorbate 20, water for injection)
5. History of anaphylaxis to any biologic therapy
6. A helminth parasitic infection diagnosed within 24 weeks before the date informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy
7. Acute asthma exacerbation 30 days before the date informed consent
8. Acute asthma exacerbation between screening and first dose of study dose administration.
9. Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days before the date informed consent
10. Patients with malignancy within 5 years prior to enrolment, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, basal, or squamous cell carcinoma or non-melanomatous skin cancer with active or recent malignancy
11. Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis, which, in the opinion of the investigator, may put the participant at risk because of his/her participation in the study
12. History of current alcohol, drug, or chemical abuse or past abuse that would impair or risk the participant’s full participation in the study, in the opinion of the investigator
13. Female patients who are pregnant or lactating or planning a family during the study period.

Location

Research Site

Vishakhapatnam, India, 530002

Location

Research Site

New Delhi, India, 110060

Location

Research Site

Jodhpur, India, 342005

Location

Research Site

Luknow, India, 226003

Location

Research Site

Chennai, India, 600035

Location

Research Site

Bengaluru, India, 560099

Location

Research Site

Mumbai, India, 400008

Location

Research Site

Delhi, India, 110029

Arms	Assigned Interventions
Other: Benralizumab Single arm, Phase-IV	Biological/Vaccine: Benralizumab Prospective, Single-arm Study to Assess the Safety of Fasenra® (Benralizumab) in Adult Patients of Severe Asthma with Eosinophilic Phenotype in India

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Benralizumab	30 mg/mL subcutaneous benralizumab once every 4 weeks for the first 3 doses, followed by a maintenance dosage of 30 mg/mL once every 8 weeks thereafter

Participant Flow: Overall Study

	Benralizumab
STARTED	139
COMPLETED	124
NOT COMPLETED	15
Withdrawal by Subject	8
Lost to Follow-up	6
One participant included in study but not included in analysis as did not meet eligibility criteria	1

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Reporting Groups

	Description
Benralizumab	30 mg/mL subcutaneous benralizumab once every 4 weeks for the first 3 doses, followed by a maintenance dosage of 30 mg/mL once every 8 weeks thereafter

Baseline Measures

	Benralizumab
Number of Participants [units: Participants]	138
Sex: Female, Male [units: Participants]
Female	71
Male	67
Race (NIH/OMB) [units: Participants]
ASIAN	138
OTHER	0
Age Continuous [units: Years] Mean ± Standard Deviation	47.7 ± 14.3
Female, Indicate childbearing potential [units: participants]
Premenarchal	0
Premenopausal female	6
Postmenopausal female	30
Potentially able to bear children	35

Outcome Measures

1. Primary Outcome Measure: Participants with adverse events (AEs), serious AEs, and treatment-emergent AEs [ Time Frame: From study treatment to follow-up (up to 24 weeks) ]

Measure Type	Primary
Measure Name	Participants with adverse events (AEs), serious AEs, and treatment-emergent AEs
Measure Description	The number and percentage of participants who experienced at least one adverse event (AE), serious AE, or treatment-emergent AE experienced are presented
Time Frame	From study treatment to follow-up (up to 24 weeks)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analysis set

Reporting Groups

	Description
Benralizumab	30 mg/mL subcutaneous benralizumab once every 4 weeks for the first 3 doses, followed by a maintenance dosage of 30 mg/mL once every 8 weeks thereafter

Measured Values

	Benralizumab
Number of Participants Analyzed [units:participants]	138
Participants with adverse events (AEs), serious AEs, and treatment-emergent AEs [units: participants]
Participants with at least one AE (including SAEs)	44
Participants with at least one serious AE	5
Participants with at least one treatment-emergent AE (including SAEs)	43
Participants with at least one non-treatment-emergent and non-serious AE	1

No statistical analysis provided for Participants with adverse events (AEs), serious AEs, and treatment-emergent AEs

2. Primary Outcome Measure: Severity of AEs [ Time Frame: From study treatment to follow-up (up to 24 weeks) ]

Measure Type	Primary
Measure Name	Severity of AEs
Measure Description	Severity of adverse events (AEs) by intensity grade
Time Frame	From study treatment to follow-up (up to 24 weeks)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analysis set

Reporting Groups

	Description
Benralizumab	30 mg/mL subcutaneous benralizumab once every 4 weeks for the first 3 doses, followed by a maintenance dosage of 30 mg/mL once every 8 weeks thereafter

Measured Values

	Benralizumab
Number of Participants Analyzed [units:participants]	138
Severity of AEs [units: participants]
Participants with at least one mild AE	33
Participants with at least one moderate AE	16
Participants with at least one severe AE	1

No statistical analysis provided for Severity of AEs

3. Primary Outcome Measure: Participants with AEs that led to study treatment discontinuations or modifications [ Time Frame: From study treatment to follow-up (up to 24 weeks) ]

Measure Type	Primary
Measure Name	Participants with AEs that led to study treatment discontinuations or modifications
Measure Description	Participants with adverse events (AEs) that led to study treatment discontinuations or modifications
Time Frame	From study treatment to follow-up (up to 24 weeks)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analysis set

Reporting Groups

	Description
Benralizumab	30 mg/mL subcutaneous benralizumab once every 4 weeks for the first 3 doses, followed by a maintenance dosage of 30 mg/mL once every 8 weeks thereafter

Measured Values

	Benralizumab
Number of Participants Analyzed [units:participants]	138
Participants with AEs that led to study treatment discontinuations or modifications [units: participants]	0

No statistical analysis provided for Participants with AEs that led to study treatment discontinuations or modifications

4. Secondary Outcome Measure: Time to first asthma exacerbation [ Time Frame: From study treatment to follow-up (up to 24 weeks) ]

Measure Type	Secondary
Measure Name	Time to first asthma exacerbation
Measure Description	Time to first asthma exacerbation in days in participants with asthma exacerbation
Time Frame	From study treatment to follow-up (up to 24 weeks)
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Evaluable Analysis Set

Reporting Groups

	Description
Benralizumab	30 mg/mL subcutaneous benralizumab once every 4 weeks for the first 3 doses, followed by a maintenance dosage of 30 mg/mL once every 8 weeks thereafter

Measured Values

	Benralizumab
Number of Participants Analyzed [units:participants]	19
Time to first asthma exacerbation [units: days] Mean (Standard Deviation)	112.6 (50.45)

Statistical Analysis 1 for Time to first asthma exacerbation

Groups^[1]	All groups
Other^[5]	100.0
95% Confidence Interval	( 65.00 to 160.0 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Estimate for Time to Response (Days)
[5]	Other relevant estimation information:
	Estimate for Time to Response using Kaplan-Meier method

5. Secondary Outcome Measure: Exacerbation Rate: Before and After Treatment [ Time Frame: From study treatment to follow-up (up to 24 weeks) ]

Measure Type	Secondary
Measure Name	Exacerbation Rate: Before and After Treatment
Measure Description	The annual exacerbation rate for each participant was calculated by dividing the total number of exacerbations by the number of days participated in the study and multiplying by 365.
Time Frame	From study treatment to follow-up (up to 24 weeks)
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Evaluable Analysis Set

Reporting Groups

	Description
Benralizumab	30 mg/mL subcutaneous benralizumab once every 4 weeks for the first 3 doses, followed by a maintenance dosage of 30 mg/mL once every 8 weeks thereafter

Measured Values

	Benralizumab
Number of Participants Analyzed [units:participants]	138
Exacerbation Rate: Before and After Treatment [units: exacerbations events/year] Mean (Standard Deviation)
Exacerbation before study	2.0 (0.00)
Exacerbation at end of study	0.2 (0.47)

No statistical analysis provided for Exacerbation Rate: Before and After Treatment

6. Secondary Outcome Measure: Annualized exacerbation rate: Overall [ Time Frame: From study treatment to follow-up (up to 24 weeks) ]

Measure Type	Secondary
Measure Name	Annualized exacerbation rate: Overall
Measure Description	Overall annualized exacerbation rate. The annual exacerbation rate for each participant was calculated by dividing the total number of exacerbations by the number of days participated in the study and multiplying by 365.
Time Frame	From study treatment to follow-up (up to 24 weeks)
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Evaluable Analysis Set

Reporting Groups

	Description
Benralizumab	30 mg/mL subcutaneous benralizumab once every 4 weeks for the first 3 doses, followed by a maintenance dosage of 30 mg/mL once every 8 weeks thereafter

Measured Values

	Benralizumab
Number of Participants Analyzed [units:participants]	138
Annualized exacerbation rate: Overall [units: exacerbation events/year]	0.36

No statistical analysis provided for Annualized exacerbation rate: Overall

7. Secondary Outcome Measure: Overall Investigators Assessment [ Time Frame: From study treatment to follow-up (up to 24 weeks) ]

Measure Type	Secondary
Measure Name	Overall Investigators Assessment
Measure Description	Overall investigator’s assessment on the outcome of the treatment: “well controlled”, “partly controlled”, and “uncontrolled.”
Time Frame	From study treatment to follow-up (up to 24 weeks)
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Evaluable Analysis Set

Reporting Groups

	Description
Benralizumab	30 mg/mL subcutaneous benralizumab once every 4 weeks for the first 3 doses, followed by a maintenance dosage of 30 mg/mL once every 8 weeks thereafter

Measured Values

	Benralizumab
Number of Participants Analyzed [units:participants]	135
Overall Investigators Assessment [units: participants]
Well controlled	83
Partly controlled	45
Uncontrolled	7

No statistical analysis provided for Overall Investigators Assessment

8. Secondary Outcome Measure: Change in blood eosinophil levels from baseline at Weeks 4, 16, and 24 [ Time Frame: Baseline and Weeks 4, 16, and 24 ]

Measure Type	Secondary
Measure Name	Change in blood eosinophil levels from baseline at Weeks 4, 16, and 24
Measure Description	Mean change in blood eosinophil levels from baseline at Weeks 4, 16, and 24
Time Frame	Baseline and Weeks 4, 16, and 24
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Evaluable Analysis Set

Reporting Groups

	Description
Benralizumab	30 mg/mL subcutaneous benralizumab once every 4 weeks for the first 3 doses, followed by a maintenance dosage of 30 mg/mL once every 8 weeks thereafter

Measured Values

	Benralizumab
Number of Participants Analyzed [units:participants]	138
Change in blood eosinophil levels from baseline at Weeks 4, 16, and 24 [units: cells/mm^3] Mean (Standard Deviation)
Week 4 (Visit 2)	-511 (779.13)
Week 16 (Visit 4)	-546 (867.79)
Week 24 (Visit 5)	-541 (893.62)

Statistical Analysis 1 for Change in blood eosinophil levels from baseline at Weeks 4, 16, and 24

Groups^[1]	All groups
Method^[3]	Other [paired t-test]
P-Value^[4]	<0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 4 (Visit 2)
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Change in blood eosinophil levels from baseline at Weeks 4, 16, and 24

Groups^[1]	All groups
Method^[3]	Other [paired t-test]
P-Value^[4]	<0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 16 (Visit 4)
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 3 for Change in blood eosinophil levels from baseline at Weeks 4, 16, and 24

Groups^[1]	All groups
Method^[3]	Other [paired t-test]
P-Value^[4]	<0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 24 (Visit 5)
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Serious Adverse Events

Time Frame	From screening to follow-up (up to 27 weeks)
Additional Description	Adverse events were reported by the participant (or when appropriate by a caregiver, surrogate, or the participant's legally authorised representative). Participants were provided a patient diary to record any undesirable health-related experience or adverse events occurring during the study. Adverse events and serious adverse events mentioned both in the patient diary and verbally communicated by the participant were recorded.

Time Frame

From screening to follow-up (up to 27 weeks)

Additional Description

Adverse events were reported by the participant (or when appropriate by a caregiver, surrogate, or the participant's legally authorised representative). Participants were provided a patient diary to record any undesirable health-related experience or adverse events occurring during the study. Adverse events and serious adverse events mentioned both in the patient diary and verbally communicated by the participant were recorded.

Reporting Groups

	Description
Benralizumab	30 mg/mL subcutaneous benralizumab once every 4 weeks for the first 3 doses, followed by a maintenance dosage of 30 mg/mL once every 8 weeks thereafter

Serious Adverse Events

Benralizumab

Total, serious adverse events

# participants affected / at risk

5/138 (3.62%)

Infections and infestations

H1n1 influenza¹,^†

# participants affected / at risk

1/138 (0.72%)

# events

Musculoskeletal and connective tissue disorders

Back pain¹,^†

# participants affected / at risk

1/138 (0.72%)

# events

Gastrointestinal disorders

Constipation¹,^†

# participants affected / at risk

1/138 (0.72%)

# events

Respiratory, thoracic and mediastinal disorders

Dyspnoea¹,^†

# participants affected / at risk

4/138 (2.90%)

# events

Respiratory, thoracic and mediastinal disorders

Productive cough¹,^†

# participants affected / at risk

4/138 (2.90%)

# events

General disorders and administration site conditions

Pyrexia¹,^†

# participants affected / at risk

3/138 (2.17%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 24.1

Other Adverse Events

Time Frame

From screening to follow-up (up to 27 weeks)

Additional Description

Frequency Threshold

Threshold above which other adverse events are reported	0%

Reporting Groups

	Description
Benralizumab	30 mg/mL subcutaneous benralizumab once every 4 weeks for the first 3 doses, followed by a maintenance dosage of 30 mg/mL once every 8 weeks thereafter

Other Adverse Events

Benralizumab

Total, other (not including serious) adverse events

# participants affected / at risk

39/138 (28.26%)

General disorders and administration site conditions

Ulcer¹,^†

# participants affected / at risk

1/138 (0.72%)

# events

Infections and infestations

Covid-19¹,^†

# participants affected / at risk

1/138 (0.72%)

# events

Infections and infestations

Nasopharyngitis¹,^†

# participants affected / at risk

3/138 (2.17%)

# events

Infections and infestations

Urinary tract infection¹,^†

# participants affected / at risk

1/138 (0.72%)

# events

Investigations

Sars-cov-2 test positive¹,^†

# participants affected / at risk

1/138 (0.72%)

# events

Musculoskeletal and connective tissue disorders

Arthralgia¹,^†

# participants affected / at risk

1/138 (0.72%)

# events

Musculoskeletal and connective tissue disorders

Pain in extremity¹,^†

# participants affected / at risk

1/138 (0.72%)

# events

Nervous system disorders

Burning sensation¹,^†

# participants affected / at risk

1/138 (0.72%)

# events

Gastrointestinal disorders

Constipation¹,^†

# participants affected / at risk

1/138 (0.72%)

# events

Nervous system disorders

Headache¹,^†

# participants affected / at risk

2/138 (1.45%)

# events

Nervous system disorders

Paraesthesia¹,^†

# participants affected / at risk

2/138 (1.45%)

# events

Nervous system disorders

Restless legs syndrome¹,^†

# participants affected / at risk

1/138 (0.72%)

# events

Renal and urinary disorders

Dysuria¹,^†

# participants affected / at risk

1/138 (0.72%)

# events

Respiratory, thoracic and mediastinal disorders

Cough¹,^†

# participants affected / at risk

4/138 (2.90%)

# events

Respiratory, thoracic and mediastinal disorders

Dyspnoea¹,^†

# participants affected / at risk

3/138 (2.17%)

# events

Respiratory, thoracic and mediastinal disorders

Haemoptysis¹,^†

# participants affected / at risk

2/138 (1.45%)

# events

Respiratory, thoracic and mediastinal disorders

Productive cough¹,^†

# participants affected / at risk

2/138 (1.45%)

# events

Respiratory, thoracic and mediastinal disorders

Throat irritation¹,^†

# participants affected / at risk

1/138 (0.72%)

# events

Skin and subcutaneous tissue disorders

Pruritus¹,^†

# participants affected / at risk

1/138 (0.72%)

# events

Gastrointestinal disorders

Gastrooesophageal reflux disease¹,^†

# participants affected / at risk

2/138 (1.45%)

# events

Gastrointestinal disorders

Nausea¹,^†

# participants affected / at risk

1/138 (0.72%)

# events

General disorders and administration site conditions

Asthenia¹,^†

# participants affected / at risk

2/138 (1.45%)

# events

General disorders and administration site conditions

Chest pain¹,^†

# participants affected / at risk

1/138 (0.72%)

# events

General disorders and administration site conditions

Non-cardiac chest pain¹,^†

# participants affected / at risk

1/138 (0.72%)

# events

General disorders and administration site conditions

Pain¹,^†

# participants affected / at risk

1/138 (0.72%)

# events

General disorders and administration site conditions

Pyrexia¹,^†

# participants affected / at risk

20/138 (14.49%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 24.1

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The Investigator shall be entitled to publish the results of, or make presentations related to, the Study, provided that any publications or presentations to be made within 2 years after completion of the Study shall require the Sponsor’s prior written consent.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact

Name/Title:	Global Clinical Lead
Organization:	AstraZeneca
Phone	1-877-240-9479
E-mail:	[email protected]

Documents available

Download
CSR Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

CSR Synopsis

Trial Results Summaries