Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Phase 2ADHERE+NCT04280718
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)
A Phase 2 study testing Efgartigimod PH20 SC in people with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), run by argenx at 147 sites in 24 countries.
Trial summary
This is the open-label extension study of phase II ARGX-113-1802 to evaluate the long-term safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- What is being tested?
- Efgartigimod PH20 SC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 147 sitesin 24 countries
- Study dates
- 18 Sep 2020to 30 Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Ability to understand the requirements of the trial, provide written informed consent (including consent for the use and disclosure of research-related health information), willingness and ability to comply with the trial protocol procedures (including required trial visits) of this trial.
- Male or female patient with one of the following options:
- Have completed the Week-48 visit of Stage B of the ARGX-113-1802 trial and are considered to be eligible for treatment with efgartigimod PH20 SC; or
- Have deteriorated during Stage B of the ARGX-113-1802 trial and are considered to be eligible for treatment with efgartigimod PH20 SC, or
- Have been offered the participation in the OLE trial due to early termination of the ARGX-113-1802 trial (because sufficient events for the primary endpoint analysis of the that trial have been reached and it is stopped) and are considered to be eligible for treatment with efgartigimod PH20 SC treatment; or
- Have completed the Week-48 visit of the previous cycle of the OLE trial and are considered to be eligible to continue with efgartigimod PH20 SC treatment.
- Women of childbearing potential who have a negative urine pregnancy test at baseline before IMP administration.
- Women of childbearing potential must use an acceptable method of contraception from signing the ICF until the date of the last administration of IMP.
Who cannot join
- Week-48/ED visit in the ARGX-113-1802 trial or the Week-48 visit of the previous OLE participation occurred more than 14 days prior to SD1 of the OLE trial or the start of a new treatment cycle in the OLE trial and more than 21 days since the last dose of IMP.
- Pregnant and lactating women and those intending to become pregnant during the trial.
- Patients with clinical evidence of other significant serious disease or patients who underwent a recent or have a planned major surgery, or patients who (intend to) use prohibited medications (see protocol) and therapies during the trial, or any other reason which could confound the results of the trial or put the patient at undue risk.
Trial locations and contacts
147 sites in 24 countries.
147 sites in 24 countries
United States25 sites
Investigator Site 0010066
Austin, Texas, 78756
Investigator site 0010065
Birmingham, Alabama, 35233-2110
Investigator site 0010072
Boca Raton, Florida, 33487
Investigator site 0010032
Carlsbad, California, 92011
Investigator site 0010057
Centennial, Colorado, 80112
Investigator site 0010003
Chapel Hill, North Carolina, 27517
Investigator site 0010064
Columbus, Ohio, 43210
Investigator site 0010144
Coral Springs, Florida, 33067-4640
Investigator site 0010015
Fairway, Kansas, 66205
Investigator site 0010011
Iowa City, Iowa, 52242
Investigator site 0010023
Jacksonville, Florida, 32209
Investigator site 10147
Lexington, Kentucky, 40536
Investigator site 0010068
Maitland, Florida, 32751
Investigator site 0010059
Miami, Florida, 33136
Investigator site 10168
New York, New York, 10016
Investigator site 0010007
Philadelphia, Pennsylvania, 19107
Investigator site 0010047
Philadelphia, Pennsylvania, 19126
Investigator site 0010013
Phoenix, Arizona, 85018
Investigator site 10190
Pomona, California, 91767-2009
Investigator site 0010160
Rancho Mirage, California, 92270-4150
Investigator site 0010061
Richmond, Virginia, 23298
Investigator site 0010009
San Antonio, Texas, 78229
Investigator site 0010071
San Francisco, California, 94109
Investigator site 0010055
Scottsdale, Arizona, 85028
Investigator site 0010006
Tampa, Florida, 33612
China19 sites
Investigator site 0860033
Beijing
Investigator site 860041
Changsha
Investigator site 0860036
Chengdu
Investigator site 860049
Chifeng, 024000
Investigator site 0860038
Fuzhou
Investigator site 0860050
Guangzhou, 510120
Investigator site 0860032
Guanzhou
Investigator site 0860045
Guiyang
Investigator site 0860035
Hangzhou, 310003
Investigator site 0860031
Jinan, 250012
Investigator site 0860040
Nanchang, 33008
Investigator site 0860043
Nanjing
Investigator site 0860028
Shanghai
Investigator site 860047
Shanghai
Investigator site 0860042
Tianjin
Investigator site 0860034
Wuhan, 430040
Investigator site 0860029
Wuhan, 430060
Investigator site 0860048
Xi'an, 710038
Investigator site 0860054
Xianyang, 712000
Japan18 sites
Investigator site 0810035
Bunkyō City
Investigator site 0810002
Chiba
Investigator site 0810030
Fuchū, 183-0042
Investigator site 0810031
Fukuoka, 812-8582
Investigator site 0810065
Ginowan
Investigator site 0810066
Hakodate
Investigator site 0810058
Hiroshima
Investigator site 0810029
Kawagoe
Investigator site 0810026
Kodaira, 187-8551
Investigator site 810061
Kyoto, 616-8255
Investigator site 0810027
Mibu, 321-0293
Investigator site 0810032
Nagoya, 466-8560
Investigator site 0810003
Osaka, 565-0871
Investigator site 0810007
Osaka, 589-8511
Investigator site 0810063
Suita, 565-0871
Investigator site 0810036
tabashi City, 173-8606
Investigator site 0810064
Tokushima
Investigator site 0810060
Yokohama
France9 sites
Investigator site 00330034
Angers
Investigator site 0330013
Bordeaux, 33076
Investigator site 330033
Clermont-Ferrand, 63003
Investigator site 0330023
Le Kremlin-Bicêtre, 94275
Investigator site 0330024
Limoges, 87042
Investigator site 330022
Nantes, 44093
Investigator site 0330021
Nice, 06202
Investigator site 0330035
Paris
Investigator site 0330020
Strasbourg, 67098
Italy9 sites
Investigator site 0390022
Brescia
Investigator site 390029
Florence, 50139
Investigator site 0390024
Genova, 16132
Investigator site 390027
Messina, 98125
Investigator site 0390003
Milan, 20122
Investigator site 0390026
Milan
Investigator site 0390023
Pisa, 56125
Investigator site 0390008
Roma, 00189
Investigator site 0390042
Torino
Russia7 sites
Investigator site 070017
Kazan', 420021
Investigator site 0070023
Kazan', 420097
Investigator site 0070020
Moscow, 117186
Investigator site 70021
Moscow, 117186
Investigator site 0070019
Rostov-on-Don, 344022
Investigator site 0070014
Saint Petersburg, 194354
Investigator site 0070021
Saransk, 430032
Germany6 sites
Investigator site 490044
Bochum, 44791
Investigator site 0490013
Cologne
Investigator site 490045
Essen, 45147
Investigator site 490021
Göttingen, 37075
Investigator site 0490016
Kiel, 24105
Investigator site 0490019
Potsdam
Georgia5 sites
Investigator site 9950020
Kutaisi, 4600
Investigator site 9950004
Tbilisi, 0112
Investigator site 9950005
Tbilisi, 0112
Investigator site 9950002
Tbilisi
Investigator Site 9950003
Tbilisi
Poland5 sites
Investigator site 0480024
Krakow, 31-202
Investigator site 0480018
Krakow, 31-539
Investigator site 0480020
Lodz, 90-324
Investigator Site 0480017
Lublin, 20-093
Investigator site 0480022
Warsaw, 07-097
Ukraine5 sites
Investigator Site 3800012
Dnipro, 49069
Investigator Site 3800010
Ivano-Frankivsk, 76008
Investigator site 3100013
Kyiv, 02000
Investigator site 3800008
Lutsk, 43024
Investigator site 3800011
Zaporizhzhya, 69068
Belgium4 sites
Investigator site 0320016
Edegem
Investigator site 0320009
Leuven, 3000
Investigator site 320024
Liège, 4000
Investigator site 320022
Woluwe-Saint-Lambert, 1200
Bulgaria4 sites
Investigator site 3590007
Pleven, 5800
Investigator site 3590005
Sofia, 1113
Investigator site 3590008
Sofia, 1431
Investigator site 3590006
Sofia, 1680
Romania4 sites
Investigator site 040002
Brasov, 500299
Investigator site 040001
Bucharest, 011302
Investigator site 040004
Constanța, 900591
Investigator site 040003
Timișoara, 300723
Taiwan4 sites
Investigator site 8860013
Tainan, 701
Investigator site 8860012
Taipei, 116
Investigator site 8860016
Taipei, 116
Investigator site 8860017
Taoyuan, 333
Austria3 sites
Investigator site 0430007
Innsbruck
Investigator site 0430008
Linz, 4021
Investigator site 0430005
Vienna, 1090
Denmark3 sites
Investigator site 0450002
Aarhus, 8200
Investigator site 0450001
Copenhagen, 2100
Investigator site 0450003
Odense, 5000
Serbia3 sites
Investigator site 3810001
Belgrade, 11000
Investigator site 3810003
Belgrade, 11000
Investigator site 3810004
Kragujevac
Spain3 sites
Investigator site 0340021
Badalona, 08035
Investigator site 0340038
Barcelona
Investigator site 0340018
Madrid, 28040
Turkey (Türkiye)3 sites
Investigator site 900025
Bursa, 16059
Investigator site 900021
Izmir
Investigator site 900022
Samsun, 55239
United Kingdom3 sites
Investigator site 440026
London
Investigator site 0440016
Oxford
Investigator site 0440018
Sheffield
Netherlands2 sites
Investigator site 0310010
Amsterdam, 1105
Investigator site 0310011
Rotterdam, 3015
About this study
Official title: Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
This is the open-label extension study of phase II ARGX-113-1802 to evaluate the long-term safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP.
Patients already stabilized on efgartigimod PH20 SC will also have the opportunity to participate in a sub study to explore less frequent dosing of efgartigimod PH20 SC.
- Being tested
- Efgartigimod PH20 SC
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efgartigimod PH20 SCBiological
Also called ARGX-113
Subcutaneous administration of efgartigimod
| Study group | Role | What they receive |
|---|---|---|
| efgartigimod PH20 SC | Experimental | Patients treated with efgartigimod PH20 SC Receives: Biological: Efgartigimod PH20 SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events and serious adverse events
Measured: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Secondary outcomes (16)
Change from baseline over time of the adjusted INCAT score
The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome).
Measured: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Change from baseline over time of the MRC Sum score
The Medical Research Council Sum Score evaluates motor strength. Evaluated on 6 muscle groups on each side, the score varies from 0 to 60 (lower score, worse outcome).
Measured: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Change from baseline over time of I-RODS disability scores
Inflammatory Rasch-built Overall Disability Scale (I-RODS) assesses the limitations of activities and social participation in patients with inflammatory neuropathies like CIDP. The score ranges from 0 to 100 (higher score, worse outcome).
Measured: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Change from baseline over time of mean grip strength
Measured: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Change from baseline over time of TUG score
The Timed Up and Go Test (TUG) is a simple test to assess a person's mobility in which the time expended to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down is measured.
Measured: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Percentage of patients without clinical deterioration over time, defined by adjusted INCAT deterioration ≥1 point compared to baseline.
The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome).
Measured: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Percentage of patients with titers of binding antibodies towards efgartigimod and the presence of neutralizing antibodies against efgartigimod.
Measured: Up to 51 weeks
Efgartigimod serum concentrations
Measured: Up to 51 weeks
Changes from baseline over time of serum IgG levels (total)
Measured: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Change from baseline over time in EQ-5D-5L
EQ-5D-5L questionnaire is a patient-reported outcome measure, ranging 0 to 100 (lower score, worse outcome).
Measured: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Change from baseline over time in BPI SF
The Brief Pain Inventory-Short Form (BPI-SF) is a patient-reported outcome measure to assess pain severity and pain interference
Measured: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Change from baseline over time in TSQM-9
The Treatment Satisfaction Questionnaire for Medication (TSQM) is a 9-item questionnaire to assess treatment satisfaction in naturalistic study designs, in which there is potential that the administration of the side effects domain of the TSQM would interfere with routine clinical care
Measured: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Change from baseline over time in RT-FSS
The Rasch-Transformed Fatigue Severity Scale (RT-FSS) is a 7-item self-reported questionnaire designed to differentiate fatigue from clinical depression. The participant has to rate from 0 to 3 their level of fatigue on 7 items (low score indicates that the statement is not very appropriate, and high score indicates agreement).
Measured: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Change from baseline over time in HADS
The Hospital Anxiety and Depression Scale (HADS) aims to measure symptoms of anxiety and depression in people with physical health problems. HADS is a 14-item scale with 7 items related to anxiety and 7 to depression
Measured: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Percentage of patients performing self-administration over time
Measured: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Percentage of patients with treatment administered by caregiver over time.
Measured: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start18 Sep 2020
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Studies of the same condition, open and under way.
- More trials run by argenxThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280718
- Sponsor's protocol ID
- ARGX-113-1902
- Other IDs
- 2019-003107-35, 2019
- Acronym
- ADHERE+
- Status last verified
- Jun 2025
- First submitted
- 20 Feb 2020
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- ClinicalTrials.gov ID
- NCT04280718
- Acronym / sponsor ID
- ADHERE+ / ARGX-113-1902
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 229 participants (actual)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 21 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is the open-label extension study of phase II ARGX-113-1802 to evaluate the long-term safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP.
Patients already stabilized on efgartigimod PH20 SC will also have the opportunity to participate in a sub study to explore less frequent dosing of efgartigimod PH20 SC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| efgartigimod PH20 SC | Experimental | Biological: Efgartigimod PH20 SCPatients treated with efgartigimod PH20 SC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ability to understand the requirements of the trial, provide written informed consent (including consent for the use and disclosure of research-related health information), willingness and ability to comply with the trial protocol procedures (including required trial visits) of this trial.
- Male or female patient with one of the following options:
- Women of childbearing potential who have a negative urine pregnancy test at baseline before IMP administration.
- Women of childbearing potential must use an acceptable method of contraception from signing the ICF until the date of the last administration of IMP.
Key exclusion criteria (3 listed)
- Week-48/ED visit in the ARGX-113-1802 trial or the Week-48 visit of the previous OLE participation occurred more than 14 days prior to SD1 of the OLE trial or the start of a new treatment cycle in the OLE trial and more than 21 days since the last dose of IMP.
- Pregnant and lactating women and those intending to become pregnant during the trial.
- Patients with clinical evidence of other significant serious disease or patients who underwent a recent or have a planned major surgery, or patients who (intend to) use prohibited medications (see protocol) and therapies during the trial, or any other reason which could confound the results of the trial or put the patient at undue risk.
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 |
|---|---|---|
| Efgartigimod PH20 SCAlso: ARGX-113Subcutaneous administration of efgartigimod | Biological | efgartigimod PH20 SC |
Primary outcome
Incidence of treatment-emergent adverse events and serious adverse events
Time frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
16 secondary outcomes
Change from baseline over time of the adjusted INCAT score
Time frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Change from baseline over time of the MRC Sum score
Time frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Change from baseline over time of I-RODS disability scores
Time frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Change from baseline over time of mean grip strength
Time frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Change from baseline over time of TUG score
Time frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Percentage of patients without clinical deterioration over time, defined by adjusted INCAT deterioration ≥1 point compared to baseline.
Time frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Percentage of patients with titers of binding antibodies towards efgartigimod and the presence of neutralizing antibodies against efgartigimod.
Time frame: Up to 51 weeks
Efgartigimod serum concentrations
Time frame: Up to 51 weeks
Changes from baseline over time of serum IgG levels (total)
Time frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Change from baseline over time in EQ-5D-5L
Time frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Change from baseline over time in BPI SF
Time frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Change from baseline over time in TSQM-9
Time frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Change from baseline over time in RT-FSS
Time frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Change from baseline over time in HADS
Time frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Percentage of patients performing self-administration over time
Time frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Percentage of patients with treatment administered by caregiver over time.
Time frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
147 sites in 24 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Efgartigimod PH20 SC in people with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), run by argenx at 147 sites in 24 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 8 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 147 sites in United States, China, Japan, France, Italy and 19 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of treatment-emergent adverse events and serious adverse events (time frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study). 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 29 Jun 2025.