Extension Study to Assess Effects of Non-interrupted Versus Interrupted and Long Term Treatment of Two Dose Regimes of Secukinumab in Subjects With Hidradenitis Suppurativa

A Multicenter, Double-blind, Randomized Withdrawal Extension Study of Subcutaneous Secukinumab to Demonstrate Long-term Efficacy, Safety and Tolerability in Subjects With Moderate to Severe Hidradenitis Suppurativa

The purpose of this extension study is to evaluate maintenance of HiSCR response in either continuous or interrupted therapy (using a randomized withdrawal period) of two dose regimens and to assess long-term efficacy, safety and tolerability of secukinumab in subjects with moderate to severe hidradenitis suppurativa completing either of the 2 Phase III studies. This is an expanded access trial for the core trials AIN457M2301 (NCT03713619) and AIN457M2302 (NCT03713619).

Study Overview

• Status: Active, not recruiting
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Drug: secukinumab; Drug: secukinumab

Detailed Description

This is a multicenter extension study to both core Phase III studies CAIN457M2301 and CAIN457M2302 (Core studies). This study contains a randomized withdrawal design, double blinded and placebo controlled up to Week 104 or loss of response. The subjects with HiSCR response after 52 weeks of treatment in the "Core studies" will be randomized at 2:1 ratio to either continue on one of the two secukinumab dosing regimens assigned in "Core studies" for another 52 weeks or will be placed on placebo. The primary endpoint is loss of response (LOR) assessed during the 52-week treatment duration (up to Week 104). Subjects who attained LOR will be transferred to open-label treatment to continue until the end of the study. Subjects on placebo who did not reach LOR up to Week 104 will be offered to continue in the open-label treatment or discontinue the study. Thus for subjects who were HiSCR responders at Week 52 of "Core studies", the open label treatment duration will vary and start either from the time of LOR or from Week 104 dose and last until Week 260 followed by 8 weeks of a post treatment follow-up period to week 268.

Subjects who were HiSCR non-responders at the end of "Core studies" will be offered to continue in open-label treatment until Week 260.

Subjects who prematurely discontinue the study, or who complete the study will enter a post-treatment follow up period (8 weeks) The primary objective is to evaluate maintenance of HiSCR reponse at Week 104 in either continuous or interrupted therapy compared to placebo. Secondary objectives are to assess the long-term safety and tolerability evaluated by adverse events, abnormal laboratory values and vital signs.

• Study Type: Interventional
• Enrollment (Actual): 703
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1425DKG
    • Novartis Investigative Site
  • Capital Federal, Argentina, C1023AAB
    • Novartis Investigative Site
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1056ABJ
      • Novartis Investigative Site
    • Ciudad Autonoma de Bs As, Buenos Aires, Argentina, C1425BEA
      • Novartis Investigative Site
    • La Plata, Buenos Aires, Argentina, B1902COS
      • Novartis Investigative Site
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000DBS
      • Novartis Investigative Site
• Australia
  • Australian Capital Territory
    • Phillip, Australian Capital Territory, Australia, 2606
      • Novartis Investigative Site
  • Queensland
    • Benowa, Queensland, Australia, 4217
      • Novartis Investigative Site
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Novartis Investigative Site
• Austria
  • Linz, Austria, 4020
    • Novartis Investigative Site
  • Wien, Austria, A 1090
    • Novartis Investigative Site
• Belgium
  • Bruxelles, Belgium, 1070
    • Novartis Investigative Site
  • Gent, Belgium, 9000
    • Novartis Investigative Site
  • Liege, Belgium, 4000
    • Novartis Investigative Site
• Bulgaria
  • Pleven, Bulgaria, 5800
    • Novartis Investigative Site
  • Sofia, Bulgaria, 1407
    • Novartis Investigative Site
  • Sofia, Bulgaria, 1606
    • Novartis Investigative Site
  • Stara Zagora, Bulgaria, 6000
    • Novartis Investigative Site
• Canada
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • Novartis Investigative Site
    • London, Ontario, Canada, N6H 5L5
      • Novartis Investigative Site
    • Peterborough, Ontario, Canada, K9J 5K2
      • Novartis Investigative Site
    • Waterloo, Ontario, Canada, N2J 1C4
      • Novartis Investigative Site
• Colombia
  • Atlantico
    • Barranquilla, Atlantico, Colombia, 080002
      • Novartis Investigative Site
• Croatia
  • HRV
    • Zagreb, HRV, Croatia, 10000
      • Novartis Investigative Site
• Czechia
  • JIhlava, Czechia, 586 01
    • Novartis Investigative Site
  • Plzen, Czechia, 30460
    • Novartis Investigative Site
  • Czech Republic
    • Usti nad Labem, Czech Republic, Czechia, 400 11
      • Novartis Investigative Site
  • Prague 1
    • Prague, Prague 1, Czechia, 11000
      • Novartis Investigative Site
• France
  • Antony, France, 92160
    • Novartis Investigative Site
  • Bordeaux Cedex, France, 33075
    • Novartis Investigative Site
  • Brest, France, 29609
    • Novartis Investigative Site
  • Creteil, France, 94010
    • Novartis Investigative Site
  • Lyon, France, 69437
    • Novartis Investigative Site
  • Martigues, France, 13500
    • Novartis Investigative Site
  • Montpellier cedex 5, France, 34295
    • Novartis Investigative Site
  • Nantes Cedex 1, France, 44093
    • Novartis Investigative Site
  • Nice, France, 06202
    • Novartis Investigative Site
  • Paris 10, France, 75475
    • Novartis Investigative Site
  • Reims, France, 51100
    • Novartis Investigative Site
  • Rouen Cedex, France, 76031
    • Novartis Investigative Site
  • Saint Mande, France, 94160
    • Novartis Investigative Site
  • Saint-Etienne, France, 42055
    • Novartis Investigative Site
  • Toulouse, France, 31400
    • Novartis Investigative Site
  • Haute Vienne
    • Limoges, Haute Vienne, France, 87000
      • Novartis Investigative Site
  • Val De Marne
    • Toulon Cedex 9, Val De Marne, France, 83800
      • Novartis Investigative Site
• Germany
  • Berlin, Germany, 13353
    • Novartis Investigative Site
  • Berlin, Germany, 10789
    • Novartis Investigative Site
  • Bielefeld, Germany, 33647
    • Novartis Investigative Site
  • Bochum, Germany, 44791
    • Novartis Investigative Site
  • Erlangen, Germany, 91054
    • Novartis Investigative Site
  • Frankfurt, Germany, 60590
    • Novartis Investigative Site
  • Halle (Saale), Germany, 06108
    • Novartis Investigative Site
  • Hamburg, Germany, 20246
    • Novartis Investigative Site
  • Heidelberg, Germany, 69120
    • Novartis Investigative Site
  • Langenau, Germany, 89129
    • Novartis Investigative Site
  • Memmingen, Germany, 87700
    • Novartis Investigative Site
  • Muenchen, Germany, 81377
    • Novartis Investigative Site
  • Muenchen, Germany, 80377
    • Novartis Investigative Site
  • Muenster, Germany, 48149
    • Novartis Investigative Site
  • Potsdam, Germany, 14467
    • Novartis Investigative Site
  • Schwerin, Germany, 19055
    • Novartis Investigative Site
  • Wuerzburg, Germany, 97080
    • Novartis Investigative Site
• Greece
  • Athens, Greece, 12462
    • Novartis Investigative Site
  • Athens, Greece, 161 21
    • Novartis Investigative Site
  • Thessaloniki, Greece, 546 43
    • Novartis Investigative Site
  • GR
    • Thessaloniki, GR, Greece, 564 03
      • Novartis Investigative Site
• Guatemala
  • Guatemala City, Guatemala, 01010
    • Novartis Investigative Site
  • Guatemala City, Guatemala, 1015
    • Novartis Investigative Site
• Hungary
  • Debrecen, Hungary, 4032
    • Novartis Investigative Site
  • Kaposvar, Hungary, 7400
    • Novartis Investigative Site
  • Pecs, Hungary, 7632
    • Novartis Investigative Site
• India
  • Delhi
    • New Delhi, Delhi, India, 110 060
      • Novartis Investigative Site
  • Karnataka
    • Mysore, Karnataka, India, 570001
      • Novartis Investigative Site
  • Maharashtra
    • Nagpur, Maharashtra, India, 440009
      • Novartis Investigative Site
    • Nashik, Maharashtra, India, 422101
      • Novartis Investigative Site
• Israel
  • Jerusalem, Israel, 9112001
    • Novartis Investigative Site
  • Petach Tikva, Israel, 4941492
    • Novartis Investigative Site
  • Ramat Gan, Israel, 52621
    • Novartis Investigative Site
  • Tel Aviv, Israel, 6423906
    • Novartis Investigative Site
• Italy
  • Napoli, Italy, 80131
    • Novartis Investigative Site
  • AN
    • Ancona, AN, Italy, 60126
      • Novartis Investigative Site
  • FE
    • Cona, FE, Italy, 44124
      • Novartis Investigative Site
  • FI
    • Firenze, FI, Italy, 50122
      • Novartis Investigative Site
  • MI
    • Milano, MI, Italy, 20122
      • Novartis Investigative Site
  • PI
    • Pisa, PI, Italy, 56124
      • Novartis Investigative Site
  • RM
    • Roma, RM, Italy, 00133
      • Novartis Investigative Site
• Japan
  • Osaka, Japan, 545-8586
    • Novartis Investigative Site
  • Aichi
    • Nagoya-city, Aichi, Japan, 467-8602
      • Novartis Investigative Site
  • Chiba
    • Kisarazu, Chiba, Japan, 292-8535
      • Novartis Investigative Site
  • Okinawa
    • Nakagami, Okinawa, Japan, 903 0215
      • Novartis Investigative Site
  • Saitama
    • Koshigaya, Saitama, Japan, 343-8555
      • Novartis Investigative Site
  • Tokyo
    • Itabashi-ku, Tokyo, Japan, 173-8610
      • Novartis Investigative Site
• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 02841
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 07441
    • Novartis Investigative Site
• Lebanon
  • Saida, Lebanon, 652
    • Novartis Investigative Site
• Lithuania
  • Vilnius, Lithuania, LT 08661
    • Novartis Investigative Site
  • LTU
    • Kaunas, LTU, Lithuania, LT 50161
      • Novartis Investigative Site
• Malaysia
  • Johor Bahru, Malaysia, 80100
    • Novartis Investigative Site
  • Penang, Malaysia, 10990
    • Novartis Investigative Site
  • Wilayah Persekutuan
    • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50586
      • Novartis Investigative Site
• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44657
      • Novartis Investigative Site
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64460
      • Novartis Investigative Site
• Netherlands
  • Bergen op Zoom, Netherlands, 4624 VT
    • Novartis Investigative Site
• Philippines
  • Las Pinas, Philippines, 1740
    • Novartis Investigative Site
  • Makati City, Philippines, 1220
    • Novartis Investigative Site
• Poland
  • Lodz, Poland, 90-436
    • Novartis Investigative Site
  • Ossy, Poland, 42 624
    • Novartis Investigative Site
  • Rzeszow, Poland, 35 055
    • Novartis Investigative Site
  • Warszawa, Poland, 04141
    • Novartis Investigative Site
  • Wroclaw, Poland, 50 566
    • Novartis Investigative Site
  • Mazowian
    • Warszawa, Mazowian, Poland, 02 495
      • Novartis Investigative Site
• Portugal
  • Lisboa, Portugal, 1998-018
    • Novartis Investigative Site
  • Lisboa, Portugal, 1169 050
    • Novartis Investigative Site
  • Porto, Portugal, 4099-001
    • Novartis Investigative Site
• Russian Federation
  • Chelyabinsk, Russian Federation, 454048
    • Novartis Investigative Site
  • Kazan, Russian Federation, 420012
    • Novartis Investigative Site
  • Krasnodar, Russian Federation, 350020
    • Novartis Investigative Site
  • Saint Petersburg, Russian Federation, 197022
    • Novartis Investigative Site
  • Saint Petersburg, Russian Federation, 191123
    • Novartis Investigative Site
  • Smolensk, Russian Federation, 214031
    • Novartis Investigative Site
  • Yaroslavl, Russian Federation, 150003
    • Novartis Investigative Site
• Singapore
  • Singapore, Singapore, 119074
    • Novartis Investigative Site
  • Singapore, Singapore, 308205
    • Novartis Investigative Site
• Slovakia
  • Kosice, Slovakia, 04001
    • Novartis Investigative Site
  • Presov, Slovakia, 081 81
    • Novartis Investigative Site
  • Slovak Republic
    • Banska Bystrica, Slovak Republic, Slovakia, 97401
      • Novartis Investigative Site
• South Africa
  • Gauteng
    • Raslouw Centurion, Gauteng, South Africa, 0157
      • Novartis Investigative Site
    • Soweto, Gauteng, South Africa, 2013
      • Novartis Investigative Site
• Spain
  • Barcelona, Spain, 08041
    • Novartis Investigative Site
  • Granada, Spain, 18012
    • Novartis Investigative Site
  • Las Palmas de Gran Canaria, Spain, 35010
    • Novartis Investigative Site
  • Madrid, Spain, 28006
    • Novartis Investigative Site
  • Madrid, Spain, 28009
    • Novartis Investigative Site
  • Pontevedra, Spain, 36003
    • Novartis Investigative Site
  • Andalucia
    • Cadiz, Andalucia, Spain, 11009
      • Novartis Investigative Site
  • Catalunya
    • Barcelona, Catalunya, Spain, 08003
      • Novartis Investigative Site
  • Comunidad Valenciana
    • Alicante, Comunidad Valenciana, Spain, 03010
      • Novartis Investigative Site
  • Madrid
    • Fuenlabrada, Madrid, Spain, 28942
      • Novartis Investigative Site
  • Valencia
    • Manises, Valencia, Spain, 46940
      • Novartis Investigative Site
• Switzerland
  • Bern, Switzerland, 3010
    • Novartis Investigative Site
  • Geneve, Switzerland, 1205
    • Novartis Investigative Site
  • Lausanne, Switzerland, 1011
    • Novartis Investigative Site
• Taiwan
  • Taipei, Taiwan, 10002
    • Novartis Investigative Site
  • Taoyuan, Taiwan, 33305
    • Novartis Investigative Site
• Turkey
  • Altunizade, Turkey, 34662
    • Novartis Investigative Site
  • Antalya, Turkey, 07070
    • Novartis Investigative Site
  • Aydin, Turkey, 09100
    • Novartis Investigative Site
  • Gaziantep, Turkey, 27310
    • Novartis Investigative Site
  • Talas / Kayseri, Turkey, 38039
    • Novartis Investigative Site
  • TUR
    • Istanbul, TUR, Turkey, 34098
      • Novartis Investigative Site
• United Kingdom
  • Barnsley, United Kingdom, S75 2EP
    • Novartis Investigative Site
  • Bristol, United Kingdom, BS1 3NU
    • Novartis Investigative Site
  • Exeter, United Kingdom, EX2 5DW
    • Novartis Investigative Site
  • London, United Kingdom, SE1 9RT
    • Novartis Investigative Site
  • London
    • Leytonstone, London, United Kingdom, E11 1NR
      • Novartis Investigative Site
  • Manchester
    • Salford, Manchester, United Kingdom, M6 8HD
      • Novartis Investigative Site
  • West Midlands
    • Dudley, West Midlands, United Kingdom, DY1 2HQ
      • Novartis Investigative Site
  • West Yorkshire
    • Bradford, West Yorkshire, United Kingdom, BD5 0NA
      • Novartis Investigative Site
    • Leeds, West Yorkshire, United Kingdom, LS7 4SA
      • Novartis Investigative Site
• United States
  • Arkansas
    • Rogers, Arkansas, United States, 72758
      • Northwest Arkansas Center .
  • California
    • San Diego, California, United States, 92123
      • University Clinical Trials
    • San Diego, California, United States, 92103
      • Novartis Investigative Site
    • Whittier, California, United States, 92677
      • Southern California Skin and Laser .
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Florida Academic Centers Research and Education Llc
    • Miami, Florida, United States, 33125
      • University of MiamiHealth System .
    • Tampa, Florida, United States, 33612
      • University of South Florida .
    • Tampa, Florida, United States, 33609
      • Olympian Clinical Research Olympian Memorial HWY Pharmacy
  • Georgia
    • Sandy Springs, Georgia, United States, 30328
      • Advanced Medical Research
  • Illinois
    • Glenview, Illinois, United States, 60077
      • Northshore University Health System
    • West Dundee, Illinois, United States, 60118
      • Dundee Dermatology
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Dawes Fretzin Clinical Rea Group .
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Cente
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center .
  • Minnesota
    • New Brighton, Minnesota, United States, 55112
      • Minnesota Clinical Study Center
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Medisearch Clinical Trials
    • Saint Louis, Missouri, United States, 63110
      • Washington Uni School of Med .
    • Saint Louis, Missouri, United States, 63104
      • Saint Louis Univ Clinical Rea Unit 3rd Floor Dermatology
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists PC .
  • New York
    • New York, New York, United States, 10029
      • Icahn School Of Med At Mount Sinai .
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27516
      • University of North Carolina
  • Ohio
    • Fairborn, Ohio, United States, 45324
      • Wright State University
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213-3403
      • University of Pittsburgh Medical Center Health System
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Clinical Research Ctr of Carolinas
  • Texas
    • Bellaire, Texas, United States, 77401
      • Bellaire Dermatology Associates
    • Dallas, Texas, United States, 75246-1613
      • MDRI Baylor University
    • Pflugerville, Texas, United States, 78660
      • Austin Inst for Clinical Research
    • San Antonio, Texas, United States, 78229
      • Dr. Stephen Miller, MDPA .
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Virginia Clinical Research .
• Vietnam
  • Hanoi, Vietnam, 100000
    • Novartis Investigative Site
  • Ho Chi Minh, Vietnam, 7000
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• written informed consent must be obtained before any assessment is performed
• subject must have completed the study treatment period (52 weeks) in the core studies (AIN457M2301 or AIN457M2302) and had received secukinumab treatment during Treatment Period 2

Exclusion Criteria:

• protocol deviation in the core study which will prevent the meaningful analysis of the extension study
• ongoing or planned use of prohibited HS or non-HS treatment
• participation in the extension could expose the subject to an undue safety risk
• current sever progressive or uncontrolled disease which renders the subject unsuitable for the study

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: secukinumab 1 HiSCR Responder; HiSCR responder at Week 52 in core trial, secukinumab 300mg every 2 weeks	Drug: secukinumab; secukinumab 300mg every 2 weeks; Other Names: AIN457; Drug: secukinumab; secukinumab 300mg every 4 weeks; Other Names: AIN457
Active Comparator: secukinumab 2 HiSCR Responder; HiSCR responder at Week 52 in core trial, secukinumab 300mg every 4 weeks	Drug: secukinumab; secukinumab 300mg every 2 weeks; Other Names: AIN457; Drug: secukinumab; secukinumab 300mg every 4 weeks; Other Names: AIN457
Placebo Comparator: placebo 1 HiSCR Responder; HiSCR responder at Week 52 in core trial, placebo to secukinumab 300mg every 2 weeks	Drug: secukinumab; secukinumab 300mg every 2 weeks; Other Names: AIN457; Drug: secukinumab; secukinumab 300mg every 4 weeks; Other Names: AIN457
Placebo Comparator: placebo 2 HiSCR Responder; HiSCR responder at Week 52 in core trial, placebo to secukinumab 300 mg every 4 weeks	Drug: secukinumab; secukinumab 300mg every 2 weeks; Other Names: AIN457; Drug: secukinumab; secukinumab 300mg every 4 weeks; Other Names: AIN457
Other: HiSCR non-responders; non-responder at Week 52 in core trial treatment; secukinumab 300mg every 2 weeks	Drug: secukinumab; secukinumab 300mg every 2 weeks; Other Names: AIN457; Drug: secukinumab; secukinumab 300mg every 4 weeks; Other Names: AIN457

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to loss of response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) reponders	Loss of response was defined as: at least a 50% increase in abscess and/or nodules count (AN) compared to the average AN count from the 3 previous visits or at Week 52, whichever is lower and the increase was at least of 3 AN.; at least a 30% increase in AN compared to the average AN count from the 3 previous visits or Week 52, whichever is lower, with an increase of at least 2 AN and a further increase in the AN count of at least 2 AN at a re-assessment visit within 2-4 weeks.	Randomized Withdrawal Period (Randomization (Week 52) - LOR or up to Week 104)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Treatment Emergent Adverse Events	To assess the long-term safety and tolerability of secukinumab in subjects with moderate to severe HS	Weeks 52 - 268

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2020
• Primary Completion (Actual): May 26, 2023
• Study Completion (Estimated): July 15, 2026

Study Registration Dates

• First Submitted: November 25, 2019
• First Submitted That Met QC Criteria: November 25, 2019
• First Posted (Actual): November 27, 2019

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: AIN457; secukinumab; Hidradenitis suppurativa; acne inversa; inflammatory disease; AIN457M; maladie de Vemeuil; Loss of response; HiSCR; IL-17A
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis; Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: CAIN457M2301E1; 2019-003230-17 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No