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Psoriatic ArthritisPhase 4SPIRIT-H2HNCT03151551

A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis

A Phase 4 study testing Ixekizumab and Adalimumab in people with Psoriatic Arthritis, run by Eli Lilly and Company at 131 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The main purpose of this study is to evaluate the effectiveness and safety of ixekizumab versus adalimumab in participants with psoriatic arthritis (PsA) who are biologic disease-modifying anti-rheumatic drugs (DMARD) naive. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriatic Arthritis
What is being tested?
Ixekizumab and Adalimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
566 participants
Where
131 sitesin 22 countries
Study dates
24 Aug 2017to 4 Sep 2019
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Presence of established diagnosis of active psoriatic arthritis for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria
  • Active PsA defined as the presence of at least 3 (out of 68) tender and at least 3 (out of 66) swollen joints
  • Presence of active plaque psoriasis with a BSA ≥3%
  • Men must agree to use a reliable method of birth control or remain abstinent during the study
  • Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
  • Have had an inadequate response when treated with 1 or more conventional synthetic disease-modifying antirheumatic drugs (csDMARDs)

Who cannot join

  • Current or prior use of biologic agents for treatment of Ps or PsA
  • Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
  • Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab
  • Serious disorder or illness other than psoriatic arthritis
  • Serious infection within the last 3 months
  • Active Crohn's disease or active ulcerative colitis
Show all 9Show fewer
  • Active vasculitis or uveitis
  • Diagnosis of or history of malignant disease <5 years prior to randomization
  • Women who are breastfeeding

Trial locations and contacts

131 sites in 22 countries.

131 sites in 22 countries

India13 sites

  • Panchshil Hospital

    Ahmedabad, Gujarat, 380005

  • Byramjee Jeejeebhoy Medical College & Civil Hospital

    Ahmedabad, Gujarat, 380016

  • Shalby Hospital

    Ahmedabad, Gujarat, 532004

  • Narayana Hrudayalaya Hospital

    Bangalore, Karnataka, 560099

  • Artemis Hospital

    Gurgaon, Haryana, 122001

  • Care Hospital

    Hyderabad, Andhra Pradesh, 500035

  • Apollo Gleneagles Hospitals

    Kolkata, West Bengal, 700054

  • Kokilaben Dhirubhai Ambani Hospital &Medical Research Inst.

    Mumbai, Maharashtra, 400053

  • Sir Ganga Ram Hospital

    New Delhi, National Capital Territory of Delhi, 110060

  • Ruby Hall Clinic and Grant Medical Foundation

    Pune, Maharashtra, 411001

  • Krishna Institute of Medical Sciences Ltd.

    Secunderabad, Telangana, 500003

  • Government Medical College & Sir Sayajirao General Hospital

    Vadodara, Gujarat, 390001

  • King George Hospital

    Visakhapatnam, Andhra Pradesh, 530002

Other trials in India

Argentina12 sites

  • Atencion Integral en Reumatología

    Ciudad Autonoma de Buenos Aire, Buenos Aires, C1426AAL

  • Organizacion Medica de Investigacion - OMI

    Ciudad Autonoma de Buenos Aire, C1015ABO

  • Instituto Centenario

    Ciudad Autonoma de Buenos Aire, C1204AAD

  • Hospital Ramos Mejia

    Ciudad Autonoma de Buenos Aire, C1221ADC

  • Centro de Medicina Familiar Mindout Research

    Ciudad Autonoma de Buenos Aire, C1417EYG

  • CENUDIAB

    Ciudad Autonoma de Buenos Aire, C1440AAD

  • Clinica Adventista de Belgrano

    Ciudad de Buenos Aires, Buenos Aires, C1430EGF

  • Consultora Integral de Salud S.R.L.

    Córdoba, 5004

  • CER Instituto Medico

    Quilmes, Buenos Aires, B1878DVC

  • Instituto de Asist Reumatologica Integral

    San Fernando, Buenos Aires, B1646DBM

  • Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan

    San Juan, J5402DIL

  • Centro Medico Privado de Reumatologia

    San Miguel de Tucumán, Tucumán Province, T4000AXL

Other trials in Argentina

United Kingdom12 sites

  • St Lukes Hospital

    Bradford, West Yorkshire, BD5 0NA

  • Addenbrookes Hospital

    Cambridge, Cambridgeshire, CB2 0QQ

  • The Dudley Group NHS Foundation Trust

    Dudley, West Midlands, DY1 2HQ

  • Western General Hospital

    Edinburgh, Scotland, EH4 2XU

  • Whipps Cross University Hospital

    London, Surrey, E11 1NR

  • North Tyneside General Hospital

    North Shields, Tyneside, NE29 8NH

  • Southampton General Hospital

    Southampton, Hants, SO16 6YD

  • The Great Western Hospital

    Swindon, Wiltshire, SN3 6BB

  • Royal Cornwall Hospital

    Truro, Cornwall, TR1 3LJ

  • Wishaw General Hospital

    Wishaw, North Lanarkshire, ML2 0DP

  • New Cross Hospital

    Wolverhampton, West Midlands, WV10 0QP

  • Wythenshawe Hospital

    Wythenshawe, Manchester, M23 9LT

Other trials in United Kingdom

South Africa9 sites

  • Suite 509 Umhlanga Netcare Medical Centre

    Durban, KwaZulu-Natal, 4319

  • St Augustines Hospital

    Durban, 4001

  • Clinresco Centres (Pt) Ltd

    Johannesburg, Gauteng, 1619

  • Emmed Research

    Muckleneuk, 0135

  • Arthritis Clinical Research Trial Unit

    Pinelands, Western Cape, 7405

  • Greenacres Hospital

    Port Elizabeth, Eastern Cape, 6045

  • Prof Ally

    Pretoria, 0002

  • Suite 209A Jakaranda Hospital

    Pretoria, 0002

  • Winelands Medical Research Centre

    Stellenbosch, Western Cape, 7600

Other trials in South Africa

Israel8 sites

  • Barzilai Medical Center

    Ashkelon, 78278

  • Rambam Medical Center

    Haifa, 3109601

  • Carmel Medical Center

    Haifa, 3436212

  • Meir Medical Center

    Kfar Saba, 4428164

  • Rabin Medical Center

    Petah Tikva, 4941492

  • Sheba Medical Center

    Ramat Gan, 5266202

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

  • Assaf Harofeh Medical Center

    Tsrifin, 6093000

Other trials in Israel

Mexico8 sites

  • Centro Investigacion de Tratam Innovadores de Sinaloa SC

    Culiacán, Sinaloa, 80000

  • RM Pharma Specialists S.A. de C.V.

    Distrito Federal, 3100

  • Cemdeicy S.C.P.

    Mérida, Yucatán, 97130

  • Centro Medico del Angel S.C.

    Mexicali, Estado de Baja California, 21100

  • Ctro Inv en Artritis y Osteoporosis SC

    Mexicali, Estado de Baja California, 21200

  • Grupo Médico CAMINO S.C.

    Mexico City, Mexico City, 03310

  • Clínica Enfermedades Crónicas y Procedimientos Especiales SC

    Morelia, Michoacán, 58249

  • CIMAB S.A. de C.V.

    Torreón, Coahuila, 27000

Other trials in Mexico

Italy7 sites

  • Istituto Ortopedico Rizzoli

    Bologna, 40136

  • Presidio Ospedaliero Vittorio Emanuele

    Catania, 95124

  • Fondazione Universitaria degli Studi G D'Annunzio

    Chieti, 66100

  • Policlinico di Tor Vergata

    Roma, 00133

  • Complesso Integrato Columbus

    Roma, 00168

  • Istituto Clinico Humanitas

    Rozzano, Milano, 20089

  • Ospedale Policlinico Giambattista Rossi, Borgo Roma

    Verona, 37134

Other trials in Italy

Ukraine7 sites

  • Regional Clinical Hospital Center for Emergency medical care

    Kharkiv

  • National Scientific Center "Strazhesko institute of cardio"

    Kyiv, 03680

  • Kyiv City Clinical Hospital #3

    Kyiv

  • Multifield Medical Center of Odesa NMU (University Clinic#1)

    Odesa, 65026

  • Municipal Institution of Ternopil Regional Council

    Ternopil, 46002

  • Vinnytsya Regional Clinical Hospital

    Vinnytsia, 21018

  • Regional Clinical Hospital of Zaporizhzhia

    Zaporizhzhya, 69600

Other trials in Ukraine

France6 sites

  • Hôpital Trousseau, CHRU de Tours

    Chambray-lès-Tours, 37170

  • Centre Hospitalier de Vendee Les Oudairies

    La Roche-sur-Yon, 85025

  • Hopital Edouard Herriot

    Lyon, 69003

  • Centre hospitalier universitaire Lapeyronie

    Montpellier, 34295

  • Nouvel Hôpital Orléans La Source

    Orléans, 45067

  • Hôpital Pierre-Paul Riquet

    Toulouse, 31059

Other trials in France

Australia5 sites

  • Emeritus Research

    Camberwell, Victoria, 3124

  • St Vincents Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Southern Clinical Research Pty Ltd

    Hobart, Tasmania, 7000

  • Combined Rheumatology Practice (CRP)

    Kogarah, New South Wales, 2217

  • Rheumatology, The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011

Other trials in Australia

Belgium5 sites

  • Reumaclinic

    Genk, 3600

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Saint Joseph Hospital

    Gilly, 6060

  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

    Leuven, 3000

  • Hopital Ambroise Pare

    Mons, 7000

Other trials in Belgium

Canada5 sites

  • The Waterside Clinic

    Barrie, Ontario, L4M 6L2

  • SKiN Center for Dermatology

    Peterborough, Ontario, K9J 5K2

  • Group de recherche en maladies osseuses

    Québec, G1V 3M7

  • Polmed Research Inc.

    Saskatoon, Saskatchewan, S7K 0H6

  • Centre de Recherche Musculo-Squelettique

    Trois-Rivières, Quebec, G8Z 1Y2

Other trials in Canada

Poland5 sites

  • NZOZ Centrum Reumatologiczne Ind. Prak.

    Elblag, 82-300

  • "Dermed" Centrum Medyczne Sp. z o.o.

    Lodz, 90-265

  • Twoja Przychodnia-Centrum Medyczne Nowa Sol

    Nowa Sól, 67100

  • Rheuma Medicus Zakład Opieki Zdrowotnej

    Warsaw, 02-118

  • DermMEDICA Sp. z o.o.

    Wroclaw, 51-318

Other trials in Poland

Spain5 sites

  • Complexo Hospitalario Universitario A Coruña, CHUAC

    A Coruña, 15006

  • Hospital Del Sagrado Coraz

    Barcelona, 08029

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, La Coruna, 15706

  • Hospital Infanta Luisa

    Seville, 41010

  • Hospital Marina Baixa

    Villajoyosa, Alicante, 03570

Other trials in Spain

Finland4 sites

  • Helsinki University Hospital, HYKS

    Helsinki, 00029

  • Kiljava Medical Research

    Hyvinkää, 05800

  • Terveystalo Kouvola

    Kouvola, 45100

  • Turun Yliopistollinen Keskussairaala

    Turku, 20521

Other trials in Finland

Germany4 sites

  • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

    Frankfurt am Main, Hesse, 60590

  • HRF Hamburger Rheuma Forschungszentrum

    Hamburg, 20095

  • Klinikum der Universität München

    München, Bavaria, 80336

  • Rheumazentrum Ratingen

    Ratingen, North Rhine-Westphalia, 40878

Other trials in Germany

Hungary4 sites

  • Obudai Egeszsegugyi Centrum Kft

    Budapest, 1036

  • UNO Medical Trials Kft.

    Budapest, 1135

  • Allergo-Derm Bakos Kft

    Szolnok, Jász-Nagykun-Szolnok, 5000

  • Vital Medical Center

    Veszprém, 8200

Other trials in Hungary

Sweden4 sites

  • Reumatologiska Kliniken Skånes universitetssjukhus Malmö

    Malmö, 205 02

  • Centrum för reumatologi

    Stockholm, 102 35

  • Reumatologiska Kliniken Karolinska Universitetssjukhuset Solna

    Stockholm, 171 76

  • Reumatologikliniken Västmanlands Sjukhus

    Västerås, Västmanland County, 72189

Other trials in Sweden

Austria3 sites

  • Zentrum für klinische Studien Dr. Ursula Hanusch GmbH

    Vienna, 1060

  • AKH

    Vienna, 1090

  • Rheuma-Zentrum Wien Oberlaa

    Vienna, 1100

Other trials in Austria

Denmark2 sites

  • Aalborg Universitetshospital - Psykiatrien

    Aalborg, 9000

  • Frederiksberg Hospital

    Frederiksberg, Capital Region, 2000

Other trials in Denmark

Switzerland2 sites

  • HUG-Hôpitaux Universitaires de Genève

    Geneva, 1206

  • Kantonsspital St. Gallen

    Sankt Gallen, Canton of St. Gallen, 9007

Other trials in Switzerland

Netherlands1 site

  • Antonius Ziekenhuis

    Sneek, 8601 ZK

Other trials in Netherlands

About this study

Official title: A 52-Week Multicenter, Randomized, Open-Label, Parallel- Group Study Evaluating the Efficacy and Safety of Ixekizumab Versus Adalimumab in Patients With Psoriatic Arthritis Who Are Biologic Disease-Modifying Anti-Rheumatic Drug Naive

The main purpose of this study is to evaluate the effectiveness and safety of ixekizumab versus adalimumab in participants with psoriatic arthritis (PsA) who are biologic disease-modifying anti-rheumatic drugs (DMARD) naive.

Being tested
Ixekizumab, Adalimumab
Medical subject headings
Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IxekizumabDrug

    Also called LY2439821

    Administered SC

  • AdalimumabDrug

    Administered SC

Study groups in NCT03151551
Study groupRoleWhat they receive
IxekizumabExperimental160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.
Receives: Drug: Ixekizumab
AdalimumabActive comparator80 mg adalimumab given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.
Receives: Drug: Adalimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Simultaneously Achieving American College of Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI100)

    ACR50 response is a ≥50% improvement from baseline for tender joint count(TJC)\& swollen joint count (SJC)\& in at least 3 of the following 5 criteria: Participant's(pts) assessment of joint pain Visual Analog Scale (VAS),Pts Global Assessment of Disease Activity (PatGA)VAS, Physician's Global Assessment of Disease Activity (PGA)VAS, Pts assessment of physical function using the Health Assessment Questionnaire-Disability Index(HAQ-DI), or High Sensitivity(assay)C-Reactive Protein (hs-CRP). PASI is an index combining assessments of the extent of body-surface involvement in head, trunk, arms, legs, and severity of desquamation, erythema and plaque thickness in each region, yielding overall score of 0-no involvement, to 72-most severe involvement. Pts achieving PASI100 were defined as having 100% improvement in the PASI score compared to baseline. Pts with active plaque PsO with a BSA≥3% \& PASI=0 at baseline were considered PASI100 responders if they had achieved PASI=0 \& BSA=0 at week 24.

    Measured: Week 24

Secondary outcomes (2)

  1. Percentage of Participants Achieving ACR50

    ACR50 response is defined as a ≥50% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of joint pain Visual Analog Scale (VAS), Participant's Global Assessment of Disease Activity (PatGA) VAS, Physician's Global Assessment of Disease Activity (PGA) VAS, participant's assessment of physical function using the Health Assessment Questionnaire-Disability Index (HAQ-DI), or High Sensitivity (assay) C-Reactive Protein (hs-CRP).

    Measured: Week 24

  2. Percentage of Participants Achieving PASI100

    PASI is an index combining assessments of the extent of body-surface involvement in head, trunk, arms, legs, and severity of desquamation, erythema and plaque thickness in each region, yielding overall score of 0-no involvement, to 72-most severe involvement. Participants achieving PASI100 were defined as having 100% improvement in the PASI score compared to baseline. Any participants with active plaque psoriasis (PsO) with a BSA ≥3% and PASI = 0 at baseline were considered PASI100 responders if \& only if they had achieved PASI=0 \& BSA=0 at week 24.

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2017
  2. Study start24 Aug 2017
  3. Primary completion15 Nov 2018
  4. Study completion4 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
566 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03151551
Sponsor's protocol ID
16687
Other IDs
I1F-MC-RHCF, 2016-004585-25, 2016
Acronym
SPIRIT-H2H
Status last verified
Sep 2019
First submitted
4 May 2017
Last updated
3 Nov 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

  • Kristensen LE, McGonagle D, Rudwaleit M, Kameda H, Wurtzen PA, Ngantcha M, Holzkamper T, Smolen J. Synergistic Improvements in Synovitis, Enthesitis, and Patient-Reported Outcomes for Patients with Psoriatic Arthritis Treated with Ixekizumab in SPIRIT Trials. Rheumatol Ther. 2025 Apr;12(2):381-395. doi: 10.1007/s40744-025-00748-8. Epub 2025 Feb 27.

    PubMed 40014255

  • Kirkham BW, Egeberg A, Behrens F, Pinter A, Merola JF, Holzkamper T, Gallo G, Ng KJ, Bolce R, Schuster C, Nash P, Puig L. A Comprehensive Review of Ixekizumab Efficacy in Nail Psoriasis from Clinical Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis. Rheumatol Ther. 2023 Oct;10(5):1127-1146. doi: 10.1007/s40744-023-00553-1. Epub 2023 Jul 3.

    PubMed 37400681

  • Deodhar AA, Combe B, Accioly AP, Bolce R, Zhu D, Gellett AM, Sprabery AT, Burmester GR. Safety of ixekizumab in patients with psoriatic arthritis: data from four clinical trials with over 2000 patient-years of exposure. Ann Rheum Dis. 2022 Jul;81(7):944-950. doi: 10.1136/annrheumdis-2021-222027. Epub 2022 Apr 7.

    PubMed 35393269

  • Elewski BE, Blauvelt A, Gallo G, Wolf E, McKean-Matthews M, Burge R, Merola JF, Gottlieb AB, Guenther LC. Simultaneous Nail and Skin Clearance in Ixekizumab Head-to-Head Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis. Dermatol Ther (Heidelb). 2022 Apr;12(4):911-920. doi: 10.1007/s13555-022-00704-2. Epub 2022 Mar 13.

    PubMed 35279805

  • Smolen JS, Sebba A, Ruderman EM, Schulze-Koops H, Sapin C, Gellett AM, Sprabery AT, Li L, de la Torre I, Gallo G, Liu-Leage S, Pillai S, Reis P, Nash P. Efficacy and Safety of Ixekizumab with or Without Methotrexate in Biologic-Naive Patients with Psoriatic Arthritis: 52-Week Results from SPIRIT-H2H Study. Rheumatol Ther. 2020 Dec;7(4):1021-1035. doi: 10.1007/s40744-020-00250-3. Epub 2020 Nov 16.

    PubMed 33200394

  • Smolen JS, Mease P, Tahir H, Schulze-Koops H, de la Torre I, Li L, Hojnik M, Sapin C, Okada M, Caporali R, Gratacos J, Goupille P, Liu Leage S, Pillai S, Nash P. Multicentre, randomised, open-label, parallel-group study evaluating the efficacy and safety of ixekizumab versus adalimumab in patients with psoriatic arthritis naive to biological disease-modifying antirheumatic drug: final results by week 52. Ann Rheum Dis. 2020 Oct;79(10):1310-1319. doi: 10.1136/annrheumdis-2020-217372. Epub 2020 Jul 13.

    PubMed 32660977

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ixekizumab and Adalimumab in people with Psoriatic Arthritis, run by Eli Lilly and Company at 131 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 131 sites in India, Argentina, United Kingdom, South Africa, Israel and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Simultaneously Achieving American College of Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI100) (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03151551, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.

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