Amyotrophic Lateral SclerosisPhase 2/3NCT03068754
Study of Acthar® Gel (Acthar) for Amyotrophic Lateral Sclerosis (ALS)
A Phase 2/3 study testing Acthar in people with Amyotrophic Lateral Sclerosis, run by Mallinckrodt at 69 sites in 7 countries.
Trial summary
About 213 people with ALS will participate in this study. There will be locations in North and South America. During the first part, participants will be randomly assigned to a group (like by flipping a coin). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Acthar
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 143 participants
- Where
- 69 sitesin 7 countries
- Study dates
- 22 Jun 2017to 25 Nov 2019
- Phase
- Phase 2/3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is 18-75 years of age at Screening
- Has ALS symptom onset within 2 years prior to Screening
- Has forced vital capacity (FVC) no higher than 60% at screening
- If taking riluzole, is on a stable dose for 4 weeks before Screening
Who cannot join
- Has tracheostomy, diaphragm pacing, or an ongoing need for assisted ventilation of any type
- Has used any medication within a time period not allowed per protocol
- Has history of Type 1 or Type 2 diabetes mellitus, or any clinically significant infection
- Used edaravone less than 1 week before Screening
- Received any stem cell replacement therapy
- Used steroids within a time period not allowed per protocol
Trial locations and contacts
69 sites in 7 countries.
69 sites in 7 countries
United States39 sites
Emory University
Atlanta, Georgia, 30322
Augusta University
Augusta, Georgia, 30912
Austin Neuromuscular Center
Austin, Texas, 78756
John Hopkins Outpatient Center
Baltimore, Maryland, 21287
University of Vermont Medical Center
Colchester, Vermont, 05401
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907
Wesley Neurology Clinic
Cordova, Tennessee, 38018
Texas Neurology, P.A.
Dallas, Texas, 75214
University of Florida - McKnight Brain Institute
Gainesville, Florida, 32611
Mercy Health- Saint Mary's
Grand Rapids, Michigan, 49503
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
The Methodist Hospital
Houston, Texas, 77030
Indiana University-Neuroscience Center of Excellence/Goodman Hall
Indianapolis, Indiana, 46202
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of California San Diego
La Jolla, California, 92037
Las Vegas Clinic
Las Vegas, Nevada, 89145
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536
Neurology Associates
Lincoln, Nebraska, 68510
Loma Linda University Health System, Department of Neurology
Loma Linda, California, 92354
Keck School of Medicine, University of Southern California
Los Angeles, California, 90033
University of California Los Angeles
Los Angeles, California, 90095
Medical College of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin, 53226
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
Columbia Presbyterian Hospital
New York, New York, 10032
University of Nebraska Medical Center - Physicians Clinical Neurosciences Center
Omaha, Nebraska, 68198
University of California Irvine Medical Center
Orange, California, 92868
Temple University School of Medicine
Philadelphia, Pennsylvania, 19140
Neuromuscular Research Center
Phoenix, Arizona, 85028
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Providence ALS Center
Portland, Oregon, 97213
VCU Medical Center
Richmond, Virginia, 23298
California Pacific Medical Center
San Francisco, California, 94115
University of California San Francisco
San Francisco, California, 94143
Mayo Clinic - Arizona
Scottsdale, Arizona, 85259
Swedish Neuroscience Institute
Seattle, Washington, 98122
University of South Florida
Tampa, Florida, 33612
Georgetown University
Washington D.C., District of Columbia, 20007
George Washington University
Washington D.C., District of Columbia, 20037
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
Argentina10 sites
IADIN
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1015ABR
STAT Research
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1023AAB
DIABAID
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1061ABD
INEBA
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1192AAW
Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1199ABB
Hospital Español
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1209AAB
Hospital Británico de Buenos Aires
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1280AEB
ILAIM
Córdoba, Córdoba Province, X5000BNB
Fundación Scherbovsky
Mendoza, Mendoza Province, CP 5500
Instituto de Neurología y Neurorrehabilitación del Litoral (INNeL )
Santa Fe, Santa Fe Province, S3000ASL
Mexico7 sites
Centro Especializado en Investigación Clínica S.C.
Boca del Río, Veracruz, 94290
Phylasis Clinicas Research
Mexico City, 54769
Hospital Universitario "Dr. José Eleuterio González"
Monterrey, Nuevo León, 64460
SMIQ BRCR Global México
Querétaro City, Querétaro, 76090
Clinical Research Institute Saltillo S.A. de C.V.
Saltillo, Coahuila, 25020
Clinical Research Institute S.C.
San Lucas Tepetlacalco, Tlalnepantla De Baz, 54055
FAICIC Clinical Researc
Veracruz, 91900
Peru5 sites
Hospital Nivel IV Carlos Alberto Seguin Escobedo
Arequipa, 04001
Hospital Nacional IV Alberto Sabogal Sologuren
Callao, 07016
Hospital Almenara
Lima, 15033
Instituto Neuro Cardiovascular de las Américas
Lima, 15074
Hospital Nacional Cayetano Heredia
Lima, 15102
Canada4 sites
Edmonton Kaye Clinic
Edmonton, Alberta, T6G 1Z1
Recherche Sepmus inc
Greenfield Park, Quebec, J4V 2J2
Centre de recherché du Centre Hospitalier de l'Universite de Montreal (CRCHUM)
Montreal, Quebec, H2XOA9
Montreal Neurological Institute & Hospital
Montreal, Quebec, H3A 2B4
Chile3 sites
Centro de Trastornos del Movimiento (CETRAM)
Santiago, Santiago Metropolitan, 8380815
Clinica Dávila
Santiago, Santiago Metropolitan, 8431657
Biomedica Research Group AV Salvador 149, oficina 1101
Santiago, 7500710
About this study
Official title: A Multicenter, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in the Treatment of Subjects With Amyotrophic Lateral Sclerosis
About 213 people with ALS will participate in this study. There will be locations in North and South America.
During the first part, participants will be randomly assigned to a group (like by flipping a coin). Out of every 3:
- 2 will get the study drug
- 1 will get a look-alike with no drug in it (placebo)
During the second part, everyone will get the study drug.
Participation will help doctors find out if Acthar can help or slow down the symptoms of ALS better than placebo.
Read the detailed description
This is a multicenter, multiple dose study to examine the effect of Acthar on functional decline in adult participants with ALS. Approximately 213 participants will be enrolled.
Following a screening period of up to 28 days, participants with ALS and symptom onset (defined as first muscle weakness or dysarthria) ≤ 2 years prior to the Screening Visit will be randomized on a 2:1 basis to receive subcutaneous (SC) Acthar 0.2 mL (16 Units [U]) daily (QD) or SC matching placebo 0.2 mL QD for 36 weeks, followed by a 3-week taper.
Participants who complete the 36 week double-blind treatment period are eligible to enter an Open Label Extension phase in which all participants will receive Acthar 0.2 mL (16 U) daily.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Acthar, Placebo
- Keywords
- ALS
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActharDrug
Also called Trade name: Acthar® Gel, Generic name: repository corticotropin injection
Repository corticotropin for subcutaneous injection
PlaceboDrug
Also called Matching Placebo, Reference Product
Matching placebo for subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Treatment Period Acthar | Experimental | Participants receive one 0.2 mL subcutaneous (SC) injection (shot under the skin) of the study drug (Acthar), daily for up to 36 weeks.
Those who do not continue into the extension period will have 3 weeks of tapering off the drug, ending their participation by Week 39. Receives: Drug: Acthar |
| Arm B: Treatment Period Placebo | Placebo comparator | Participants receive one 0.2 mL SC injection that looks like Acthar, but has no drug in it (Matching Placebo), daily for up to 36 weeks.
Those who do not continue into the extension period will have 3 weeks of simulated tapering, ending their participation by Week 39. Receives: Drug: Placebo |
| Arm C: Extension Period Acthar-Acthar | Experimental | Participants who receive Acthar during the treatment period and continue into the extension period do not go through the treatment-period tapering, but receive one 0.2 mL SC injection of Acthar, daily for up to 48 weeks, followed by 3 weeks of tapering off the drug, ending their participation within about 21 months. Receives: Drug: Acthar |
| Arm D: Extension Period Placebo-Acthar | Experimental | Participants who receive Placebo during the treatment period and continue into the extension period do not go through the treatment-period simulated tapering, but receive one 0.2 mL SC injection of Acthar, daily for up to 48 weeks, followed by 3 weeks of tapering off the drug, ending their participation within about 21 months. Receives: Drug: Acthar; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Period: Scores on a Scale for Telephone-administered Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)
The ALSFRS-R is a validated questionnaire-based scale used extensively as a primary outcome measure in ALS clinical trials and is considered a predictor of survival.
ALSFRS-R is a 12-item scale that measures 4 domains relevant for ALS (gross motor, fine motor, bulbar and respiratory)
A trained, independent rater calls each participant (or the caregiver) to administer the questionnaire. The 12 functions are rated on a scale from 0 to 4, with a highest possible (summed) score of 48. Higher scores represent better function.
Measured: Baseline, Week 36
Number of Participants Experiencing an Adverse Event During the Treatment Period
Serious adverse events, non-serious treatment-emergent adverse events, and all-cause mortality are collected until the participant no longer participates in the study Clinically significant changes in safety measures are recorded as adverse events.
Measured: by the end of the treatment period (within 36 Weeks)
Number of Participants Experiencing an Adverse Event by the End of the Trial in the OLE Period
Serious adverse events, non-serious treatment-emergent adverse events, and all-cause mortality are collected until the participant no longer participates in the study (estimated about 1 year for participants leaving after the treatment period, and two years for participants who participate also in the open label extension). Clinically significant changes in safety measures are recorded as adverse events.
Measured: by the time of database lock (within 84 weeks)
Secondary outcomes (3)
Treatment Period: Spirometry (%)
Spirometry (meaning the measuring of breath) is the most common of the lung function tests. It measures how much air can be inhaled [Forced Vital Capacity (FVC)] and exhaled [(Forced Expiratory Volume in one second (FEV1)].
Measured: Baseline, Week 36
Treatment Period: Scores on a Scale for Investigator-administered ALSFRS-R
The ALSFRS-R is a 12-item scale evaluating 4 domains relevant to ALS (gross motor, fine motor, bulbar and respiratory).
The trained investigator (or designee) administers the ALSFRS-R questionnaire in person with the participant (or caregiver). The 12 functions are rated on a scale from 0 to 4, with a highest possible (summed) score of 48. Higher scores represent better function.
Measured: Baseline, Week 36
Extension Period: Scores on a Scale for Investigator-administered ALSFRS-R
The ALSFRS-R is a 12-item scale evaluating 4 domains relevant to ALS (gross motor, fine motor, bulbar and respiratory).
The trained investigator (or designee) administers the ALSFRS-R questionnaire in person with the participant (or caregiver). The 12 functions are rated on a scale from 0 to 4, with a highest possible score of 48. Higher scores represent better function.
Measured: Baseline, Week 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start22 Jun 2017
- Primary completion25 Nov 2019
- Study completion25 Nov 2019
Why it stopped: As recommended by the study's independent Data and Safety Monitoring Board (DSMB)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to treatment group randomly (like flipping a coin). They will have a 2 out of 3 chance of receiving the study drug, and a 1 out of 3 chance of receiving placebo during the treatment period. All participants who continue into the extension period receive Acthar.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Team Leader, Study director, Mallinckrodt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068754
- Sponsor's protocol ID
- MNK14042068
- Status last verified
- Sep 2020
- First submitted
- 23 Feb 2017
- Last updated
- 14 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in the Treatment of Subjects With Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT03068754
- Acronym / sponsor ID
- MNK14042068
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- ALS
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: As recommended by the study's independent Data and Safety Monitoring Board (DSMB)
- Enrolment
- 143 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2017 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 3 Mar 2017 (actual)
- Results
- Posted 3 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
About 213 people with ALS will participate in this study. There will be locations in North and South America.
During the first part, participants will be randomly assigned to a group (like by flipping a coin). Out of every 3:
- 2 will get the study drug
- 1 will get a look-alike with no drug in it (placebo)
During the second part, everyone will get the study drug.
Participation will help doctors find out if Acthar can help or slow down the symptoms of ALS better than placebo.
Detailed description
This is a multicenter, multiple dose study to examine the effect of Acthar on functional decline in adult participants with ALS. Approximately 213 participants will be enrolled.
Following a screening period of up to 28 days, participants with ALS and symptom onset (defined as first muscle weakness or dysarthria) ≤ 2 years prior to the Screening Visit will be randomized on a 2:1 basis to receive subcutaneous (SC) Acthar 0.2 mL (16 Units [U]) daily (QD) or SC matching placebo 0.2 mL QD for 36 weeks, followed by a 3-week taper.
Participants who complete the 36 week double-blind treatment period are eligible to enter an Open Label Extension phase in which all participants will receive Acthar 0.2 mL (16 U) daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Participants will be assigned to treatment group randomly (like flipping a coin). They will have a 2 out of 3 chance of receiving the study drug, and a 1 out of 3 chance of receiving placebo during the treatment period. All participants who continue into the extension period receive Acthar.
| Arm | Type | Receives |
|---|---|---|
| Arm A: Treatment Period Acthar | Experimental | Drug: ActharParticipants receive one 0.2 mL subcutaneous (SC) injection (shot under the skin) of the study drug (Acthar), daily for up to 36 weeks. Those who do not continue into the extension period will have 3 weeks of tapering off the drug, ending their participation by Week 39. |
| Arm B: Treatment Period Placebo | Placebo comparator | Drug: PlaceboParticipants receive one 0.2 mL SC injection that looks like Acthar, but has no drug in it (Matching Placebo), daily for up to 36 weeks. Those who do not continue into the extension period will have 3 weeks of simulated tapering, ending their participation by Week 39. |
| Arm C: Extension Period Acthar-Acthar | Experimental | Drug: ActharParticipants who receive Acthar during the treatment period and continue into the extension period do not go through the treatment-period tapering, but receive one 0.2 mL SC injection of Acthar, daily for up to 48 weeks, followed by 3 weeks of tapering off the drug, ending their participation within about 21 months. |
| Arm D: Extension Period Placebo-Acthar | Experimental | Drug: Acthar, Drug: PlaceboParticipants who receive Placebo during the treatment period and continue into the extension period do not go through the treatment-period simulated tapering, but receive one 0.2 mL SC injection of Acthar, daily for up to 48 weeks, followed by 3 weeks of tapering off the drug, ending their participation within about 21 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Is 18-75 years of age at Screening
- Has ALS symptom onset within 2 years prior to Screening
- Has forced vital capacity (FVC) no higher than 60% at screening
- If taking riluzole, is on a stable dose for 4 weeks before Screening
Key exclusion criteria (6 listed)
- Has tracheostomy, diaphragm pacing, or an ongoing need for assisted ventilation of any type
- Has used any medication within a time period not allowed per protocol
- Has history of Type 1 or Type 2 diabetes mellitus, or any clinically significant infection
- Used edaravone less than 1 week before Screening
- Received any stem cell replacement therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActharAlso: Trade name: Acthar® Gel, Generic name: repository corticotropin injectionRepository corticotropin for subcutaneous injection | Drug | Arm A: Treatment Period Acthar, Arm C: Extension Period Acthar-Acthar, Arm D: Extension Period Placebo-Acthar |
| PlaceboAlso: Matching Placebo, Reference ProductMatching placebo for subcutaneous injection | Drug | Arm B: Treatment Period Placebo, Arm D: Extension Period Placebo-Acthar |
Primary outcome
Treatment Period: Scores on a Scale for Telephone-administered Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)
Time frame: Baseline, Week 36
The ALSFRS-R is a validated questionnaire-based scale used extensively as a primary outcome measure in ALS clinical trials and is considered a predictor of survival. ALSFRS-R is a 12-item scale that measures 4 domains relevant for ALS (gross motor, fine motor, bulbar and respiratory) A trained, independent rater calls each participant (or the caregiver) to administer the questionnaire. The 12 functions are rated on a scale from 0 to 4, with a highest possible (summed) score of 48. Higher scores represent better function.
Number of Participants Experiencing an Adverse Event During the Treatment Period
Time frame: by the end of the treatment period (within 36 Weeks)
Serious adverse events, non-serious treatment-emergent adverse events, and all-cause mortality are collected until the participant no longer participates in the study Clinically significant changes in safety measures are recorded as adverse events.
Number of Participants Experiencing an Adverse Event by the End of the Trial in the OLE Period
Time frame: by the time of database lock (within 84 weeks)
Serious adverse events, non-serious treatment-emergent adverse events, and all-cause mortality are collected until the participant no longer participates in the study (estimated about 1 year for participants leaving after the treatment period, and two years for participants who participate also in the open label extension). Clinically significant changes in safety measures are recorded as adverse events.
3 secondary outcomes
Treatment Period: Spirometry (%)
Time frame: Baseline, Week 36
Treatment Period: Scores on a Scale for Investigator-administered ALSFRS-R
Time frame: Baseline, Week 36
Extension Period: Scores on a Scale for Investigator-administered ALSFRS-R
Time frame: Baseline, Week 84
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Team Leader study director
Mallinckrodt
69 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Acthar in people with Amyotrophic Lateral Sclerosis, run by Mallinckrodt at 69 sites in 7 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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in United States, Argentina, Mexico, Peru, Canada and 2 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 3 Sep 2020). 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?
Treatment Period: Scores on a Scale for Telephone-administered Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) (time frame: Baseline, Week 36). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2020.