A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP)

A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Progressive Supranuclear Palsy

The purpose of this study was to assess efficacy, safety, tolerability, and pharmacokinetics of ABBV-8E12 in participants with progressive supranuclear palsy (PSP).

Study Overview

• Status: Terminated
• Conditions: Progressive Supranuclear Palsy
• Intervention / Treatment: Drug: Placebo; Drug: ABBV-8E12

Detailed Description

This was a Phase 2, randomized, double-blind, placebo-controlled, multiple dose, multicenter study consisting of a screening period of up to 8 weeks (56 days), a 52-week double-blind treatment period, and a post-treatment follow-up period of approximately 20 weeks following last study drug administration (for those participants who prematurely discontinued from treatment, declined to participate in or did not qualify for participation in a long term extension [LTE] study). At the end of the treatment period, extended treatment was available for eligible participants who completed the 52-week treatment period and entered the separate long-term extension study (NCT03391765; Study M15-563). There were 3 cohorts in the study (Cohort 1, Cohort J1, and Cohort 2). Cohort 1 had augmented safety and pharmacokinetic (PK) assessments in the first 30 participants enrolled into the global study from countries other than Japan. Cohort J1 had augmented safety and PK assessments in the first 9 participants enrolled into the study from Japan. Cohort 2 consisted of all other participants enrolled in the global study not participating in Cohort 1 or Cohort J1.

This study was prematurely discontinued because the program for progressive supranuclear palsy was discontinued due to lack of efficacy of study drug.

• Study Type: Interventional
• Enrollment (Actual): 378
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital /ID# 154403
  • Queensland
    • Herston, Queensland, Australia, 4006
      • Q-Pharm Pty Limited /ID# 154410
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital /ID# 153157
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Alfred Hospital /ID# 153158
  • Western Australia
    • West Perth, Western Australia, Australia, 6005
      • Neurodegenerative Disorders Re /ID# 153770
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • University of Calgary /ID# 154393
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 1Z9
      • OCT Research ULC /ID# 169688
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital /ID# 152818
  • Quebec
    • Montreal, Quebec, Canada, H2X 0A9
      • Crchum /Id# 152819
    • Montreal, Quebec, Canada, H3A 2B4
      • Montreal Neurological Institut /ID# 156413
• France
  • Bordeaux, France, 33076
    • Chu de Bordeaux Hopital /Id# 153151
  • Lille, France, 59037
    • Hopital B Roger Salengro /ID# 153943
  • Paris, France, 75651
    • Hopital Pitie Salpetriere /ID# 153942
  • Strasbourg, France, 67200
    • CHU Strasbourg Hautepierre Hos /ID# 206942
  • Haute-Garonne
    • Toulouse, Haute-Garonne, France, 31059
      • Hopital Universitaire Purpan /ID# 153152
  • Provence-Alpes-Cote-d Azur
    • Marseille CEDEX 05, Provence-Alpes-Cote-d Azur, France, 13385
      • Hopital de la Timone /ID# 153113
• Germany
  • Hausham, Germany, 83734
    • KH Agatharied /ID# 154166
  • Munich, Germany, 80802
    • TU Uniklinik Munchen /ID# 153154
  • Nordrhein-Westfalen
    • Bochum, Nordrhein-Westfalen, Germany, 44791
      • St. Josef-Hospital /ID# 201984
  • Sachsen
    • Leipzig, Sachsen, Germany, 04103
      • Universitaetsklinikum Leipzig /ID# 201761
  • Thueringen
    • Ulm, Thueringen, Germany, 89081
      • Universitaetsklinikum Ulm /ID# 153155
• Italy
  • Milan, Italy, 20133
    • Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 201982
  • Pozzilli, Italy, 86077
    • Istituto Neuro Mediterraneo IR /ID# 153106
  • Terni, Italy, 05100
    • A.O. Santa Maria /ID# 153102
  • Venezia LIDO, Italy, 30126
    • IRCCS Ospedale San Camillo /ID# 153101
  • Calabria
    • Catanzaro, Calabria, Italy, 88100
      • Universita di Catanzaro Magna Graecia /ID# 166322
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Policlinico Agostino Gemelli /ID# 153104
  • Milano
    • Rozzano, Milano, Italy, 20089
      • IBD Center - IRCCS Istituto Clinico Humanitas /ID# 155092
• Japan
  • Aichi
    • Nagoya-shi, Aichi, Japan, 4658620
      • National Hospital Organization Higashinagoya National Hospital /ID# 201514
  • Hokkaido
    • Asahikawa, Hokkaido, Japan, 070-8644
      • National Hospital Organization Asahikawa Medical Center /ID# 201585
  • Kyoto
    • Kyoto City, Kyoto, Japan, 616-8255
      • National Hospital Organization Utano National Hospital /ID# 201979
  • Miyagi
    • Sendai, Miyagi, Japan, 982-8555
      • NHO Sendai Nishitaga National Hospital /ID# 202132
    • Sendai-shi, Miyagi, Japan, 980-8574
      • Tohoku University Hospital /ID# 202307
  • Niigata
    • Niigata-shi, Niigata, Japan, 951-8520
      • Niigata University Medical & Dental Hospital /ID# 201680
  • Osaka
    • Suita-shi, Osaka, Japan, 565-0871
      • Osaka University Hospital /ID# 201980
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8431
      • Juntendo University Hospital /ID# 200870
    • Kodaira, Tokyo, Japan, 187-8551
      • National Center of Neurology and Psychiatry /ID# 202037
• Spain
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon /ID# 200876
  • Sevilla, Spain, 41001
    • Hosp Univ Virgen del Rocio /ID# 201039
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham - Main /ID# 144892
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic - Scottsdale /ID# 144893
  • California
    • Beverly Hills, California, United States, 90211
      • Cedars-Sinai Medical Center /ID# 149775
    • La Jolla, California, United States, 92093
      • Ucsd /Id# 144905
    • Los Angeles, California, United States, 90033
      • Usc /Id# 149773
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles /ID# 144896
    • San Francisco, California, United States, 94143-2204
      • Univ California, San Francisco /ID# 144897
  • Colorado
    • Englewood, Colorado, United States, 80113-2736
      • Rocky Mountain Movement Disorders Center /ID# 153397
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida - Archer /ID# 144906
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic /ID# 144911
    • Tampa, Florida, United States, 33612
      • University of South Florida /ID# 144912
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Georgia Regents University /ID# 144908
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center /ID# 144894
    • Chicago, Illinois, United States, 60637-1443
      • University of Chicago /ID# 148672
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University /ID# 149036
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Chandler Medical Center /ID# 144891
  • Minnesota
    • Rochester, Minnesota, United States, 55905-0001
      • Mayo Clinic - Rochester /ID# 144895
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Hosp. of Kansas Cit /ID# 168629
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Cleveland Clinic Lou Ruvo Cent /ID# 148919
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Robert Wood Johnson /ID# 144901
  • New York
    • New York, New York, United States, 10032-3725
      • COLUMBIA University Medical Center /ID# 149037
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Main Campus /ID# 144885
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University /ID# 149774
  • Tennessee
    • Nashville, Tennessee, United States, 37232-0011
      • Vanderbilt Univ Med Ctr /ID# 144898
  • Texas
    • Dallas, Texas, United States, 75231-4316
      • Kerwin Research Center /ID# 144904
    • Houston, Texas, United States, 77054
      • McGovern Medical School /ID# 149236
    • Round Rock, Texas, United States, 78681
      • Central Texas Neurology Consul /ID# 167417

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• Male or female participant with age 40 years or greater at the time of signed consent
• Meets the criteria for possible or probable progressive supranuclear palsy (PSP; Steele-Richardson-Olszewski Syndrome)
• Presence of PSP symptoms for less than 5 years
• Participant is able to walk 5 steps with minimal assistance (stabilization of one arm or use of cane/walker)
• Participant has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend)

Key Exclusion Criteria:

• Participants who weigh less than 44 kg (97 lbs) at screening
• Mini-Mental State Examination (MMSE) score less than 15 at screening
• Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI)
• Participant resides at a skilled nursing or dementia care facility, or admission to such a facility is planned during the study period
• Evidence of any clinically significant neurological disorder other than PSP
• The participant has a history of or currently has schizophrenia, schizoaffective disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) or International Classification of Diseases (ICD-10) criteria
• Participant has had a significant illness or infection requiring medical intervention in the past 30 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 0.9% Sodium Chloride Injection/Solution for Infusion; intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks	Drug: Placebo; Participants with 44-49 kg body weight (BW) had an intravenous infusion rate of 3.5 mL/min or 210 mL/hr; those with 50-58 kg BW, 4.0 mL/min or 240 mL/hr; and those with a BW >59 kg, 4.7 mL/min or 282 mL/hr.
Experimental: ABBV-8E12 2000 mg; Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)	Drug: ABBV-8E12; Participants with 44-49 kg body weight (BW) had an intravenous infusion rate of 3.5 mL/min or 210 mL/hr; those with 50-58 kg BW, 4.0 mL/min or 240 mL/hr; and those with a BW >59 kg, 4.7 mL/min or 282 mL/hr. For participants in Cohort 2, ABBV-8E12 doses may have been decreased after the evaluation by the Data Monitoring Committee of available safety, tolerability and pharmacokinetic data.; Other Names: Tilavonemab
Experimental: ABBV-8E12 4000 mg; Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)	Drug: ABBV-8E12; Participants with 44-49 kg body weight (BW) had an intravenous infusion rate of 3.5 mL/min or 210 mL/hr; those with 50-58 kg BW, 4.0 mL/min or 240 mL/hr; and those with a BW >59 kg, 4.7 mL/min or 282 mL/hr. For participants in Cohort 2, ABBV-8E12 doses may have been decreased after the evaluation by the Data Monitoring Committee of available safety, tolerability and pharmacokinetic data.; Other Names: Tilavonemab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Week 52 in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score	The PSPRS consists of 28 items grouped in six domains: daily activities (by history); behavior; bulbar; ocular motor; limb motor; and gait/midline. Items are scored on a 0 to 4 scale, except for six items that are scored on a 0 to 2 scale, with the total score ranging from 0 to 100. Higher scores indicate more severe disability or movement abnormality. Positive changes in score indicate worsening from baseline.	Baseline, Week 52
Number of Participants With Adverse Events	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity from first dose of study drug until 20 weeks after the last dose. For more details on AEs please see the Adverse Event section.	From the first dose of study drug until 20 weeks following discontinuation of study drug administration have elapsed (approximately 5 half-lives), up to 80 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline to Week 52 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)	The Unified Parkinson's Disease Rating Scale (UPDRS) is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions related to Activities of Daily Living, and ranges from 0-52. Higher scores are associated with more disability. Positive changes in score indicate worsening from baseline.	Baseline, Week 52
Clinical Global Impression of Change (CGI-C) Score at Week 52	The Clinical Global Impression of Change (CGI-C) score is a clinician's rating scale for assessing Global Improvement of Change. The CGI-C rates improvement by 7 categories: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), very much worse (7). The CGI-C score ranges from 1 to 7, with lower scores indicating improvement.	Week 52
Mean Change From Baseline to Week 52 in Midbrain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)	Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify midbrain atrophy. Negative changes in values indicate a reduction in volume.	Baseline, Week 52
Mean Change From Baseline to Week 52 in Schwab and England Activities of Daily Living Scale (SEADL)	The Schwab and England Activities of Daily Living (SEADL) consists of ten items intended to evaluate the daily life activities of a participant. The SEADL is composed of two sections: the first is a self-reported questionnaire in which participants grade their own daily life activities, such as dressing, using the toilet, resting, eating, and social activities (subjective assessment), and the second is an assessment of motor functions, such as postural balance, speaking, rigidity, and tremors, conducted by a clinician (objective assessment). It is a percentage scale divided into deciles, and the results are reported between 0% (bedridden) and 100% (healthy). Negative changes in values indicate a decline in health.	Baseline, Week 52
Maximum Observed Serum Concentration (Cmax) for ABBV-8E12	The maximum observed serum concentration after the first and the fifth doses in Cohort 1 and Cohort J1 was determined.	First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113
Time to Maximum Observed Serum Concentration (Tmax) for ABBV-8E12	The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax, the maximum plasma concentration. Tmax was measured after the first and the fifth doses in Cohort 1 and Cohort J1.	First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113
Area Under the Concentration Time Curve (AUC) for ABBV-8E12	The area under the plasma concentration-time curve (AUC; measured in µg•day/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ABBV-8E12 was estimated using non-compartmental methods after the first and the fifth doses in Cohort 1 and Cohort J1.	First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113
Serum Concentration of ABBV-8E12 Prior to Infusion of a Day of Dosing (Ctrough)	The concentration of ABBV-8E12 immediately prior to infusion of the fifth dose (Ctrough; measured in µg/mL) was estimated using non-compartmental methods in Cohort 1 and Cohort J1.	First day of the Fifth Dosing Interval, Day 85
Mean Change From Baseline to Week 52 in Clinical Global Impression of Severity (CGI-S) Score	The CGI-S is a clinician's rating of disease severity. The CGI-S rates severity of illness on a 7-point scale, using a range of responses from 1 (normal) through 7 (the most severely ill). This rating is based upon observed and reported symptoms, behavior, and function in the past 7 days. Positive changes in score indicate worsening from baseline.	Baseline, Week 52
Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Health Related Quality of Life Scale (PSP-QoL) Total Score	The PSP-QoL is a validated patient-reported outcome measure, specifically designed to assess the quality of life of participants with PSP. There are 45 items and two subscales: physical and mental impact. Items are scored from 0 (no problem) to 4 (extreme problems). The total subscale sum scores are linearly converted into a 0 to 100 scale, and higher scores indicate a lower quality of life. Positive changes in score indicate a decline in quality of life.	Baseline, Week 52
Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Staging System Score (PSP-SS) Score	The Progressive Supranuclear Palsy Rating Scale (PSPRS) consists of 28 items grouped in six domains: daily activities (by history); behavior; bulbar; ocular motor; limb motor; and gait/midline. Items are scored on a 0 to 4 scale, except for four items that are scored on a 0 to 2 scale, with the total score ranging from 0 to 100. Higher scores indicate more severe disability or movement abnormality. The PSP-SS score is a composite of the dysphagia and gait items from the PSPRS. Positive changes in score indicate worsening from baseline.	Baseline, Week 52
Mean Change From Baseline to Week 52 in Third Ventricle Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)	Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify third ventricle atrophy. Positive changes in values indicate an increase in volume.	Baseline, Week 52
Mean Change From Baseline to Week 52 in Superior Cerebellar Peduncle Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)	Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify Superior cerebellar peduncle atrophy. Negative changes in values indicate a reduction in volume.	Baseline, Week 52
Mean Change From Baseline to Week 52 in Brainstem Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)	Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify brainstem atrophy. Negative changes in values indicate a reduction in volume.	Baseline, Week 52
Mean Change From Baseline to Week 52 in Whole Brain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)	Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify whole brain atrophy. Negative changes in values indicate a reduction in volume.	Baseline, Week 52
Mean Change From Baseline to Week 52 in Frontal Lobe Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)	Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify frontal lobe atrophy. Positive changes in values indicate an increase in volume.	Baseline, Week 52
Time to Loss of Ability to Walk Independently as Measured by Progressive Supranuclear Palsy Rating Scale (PSPRS) Item 26	The PSPRS consists of 28 items grouped in six domains: daily activities (by history); behavior; bulbar; ocular motor; limb motor; and gait/midline. Items are scored on a 0 to 4 scale, except for six items that are scored on a 0 to 2 scale, with the total score ranging from 0 to 100. Higher scores indicate more severe disability or movement abnormality. Item 26 pertains to gait, scored as either 0 (normal); 1 (slightly wide-based or irregular or slight pulsion on turns); 2 (must walk slowly or occasionally use walls or helper to avoid falling, especially on turns); 3 (must use assistance all or almost all the time); or 4 (unable to walk, even with walker; may be able to transfer).	From Baseline to Week 52

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

General Publications

• Höglinger GU, Litvan I, Mendonca N, Wang D, Zheng H, Rendenbach-Mueller B, Lon HK, Jin Z, Fisseha N, Budur K, Gold M, Ryman D, Florian H; Arise Investigators. Safety and efficacy of tilavonemab in progressive supranuclear palsy: a phase 2, randomised, placebo-controlled trial. Lancet Neurol. 2021 Mar;20(3):182-192. doi: 10.1016/S1474-4422(20)30489-0.

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2016
• Primary Completion (Actual): November 20, 2019
• Study Completion (Actual): November 20, 2019

Study Registration Dates

• First Submitted: December 1, 2016
• First Submitted That Met QC Criteria: December 5, 2016
• First Posted (Estimate): December 7, 2016

Study Record Updates

• Last Update Posted (Actual): February 3, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: PSP; Tauopathy; Steele-Richardson-Olszewski syndrome
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Tauopathies; Cranial Nerve Diseases; Ocular Motility Disorders; Paralysis; Ophthalmoplegia; Supranuclear Palsy, Progressive; Nootropic Agents; Tilavonemab
• Other Study ID Numbers: M15-562; 2016-001635-12 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No