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TerminatedNCT04224688myOpportunITy2Updated Aug 8, 2023Results posted

A Study to Assess the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)

A Phase 3 interventional study of Rozanolixizumab and Placebo in Primary Immune Thrombocytopenia, sponsored by UCB Biopharma SRL. Terminated at 29 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-08.

Sponsored by UCB Biopharma SRL (part of UCB S.A.) · Phase 3, Interventional, and Treatment

Why this study was terminated
Strategic Business Decision; Not a safety decision
Phase
Phase 3
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to demonstrate the clinical efficacy of rozanolixizumab in maintenance treatment and assess safety and tolerability of rozanolixizumab in adult study participants with primary immune thrombocytopenia (ITP).

02

Conditions studied

  • Primary Immune Thrombocytopenia

Keywords

  • ITP
  • UCB7665
  • Rozanolixizumab
  • Primary Immune Thrombocytopenia
03

In context

Purpura, Thrombocytopenic, Idiopathic

521 studies on the registry are indexed under Purpura, Thrombocytopenic, Idiopathic; 158 are open to participants now.

This study's enrollment of 30 is below the median of 58 across 383 interventional studies indexed under Purpura, Thrombocytopenic, Idiopathic.

Browse Purpura, Thrombocytopenic, Idiopathic studies →

Lead sponsor

UCB Biopharma SRL is the lead sponsor of 129 studies on the registry; 18 are open to participants now.

Of its 71 completed or terminated interventional studies of FDA-regulated products, 50 (70%) have results posted.

Browse UCB Biopharma SRL studies →All UCB S.A. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Study participant must be ≥18 years of age at the time of the Screening Visit
  • Study participant has a diagnosis of persistent (>3 months duration) or chronic (>12 months duration) primary immune thrombocytopenia (ITP) at the Screening Visit
  • Study participant has a documented intolerance or insufficient response to two or more appropriate standard of care ITP treatments prior to Screening
  • Study participants must have prior history of a response to a previous ITP therapy.
  • If taking allowed drugs, study participant must be on stable doses during defined time periods prior to Baseline (Day 1)
  • Study participant has a documented history of low platelet count (\<30×10\^9/L) prior to Screening
  • Study participant has a platelet count measurement at Screening and at Baseline (Day 1) with an average of the two \<30×10\^9/L and no single count may be >35×10\^9/L (using local laboratories)
  • Study participant has a current or history of a peripheral blood smear consistent with ITP

  • Study participants may be male or female:

    1. A male participant must agree to use contraception during the Treatment Period and for at least 3 months after the final dose of study treatment and refrain from donating sperm during this period
    2. A female participant is eligible to participate if she is not pregnant as confirmed by a negative serum pregnancy test and not planning to get pregnant during the participation in the study, not breastfeeding, and at least one of the following conditions applies:

Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 3 months after the dose of study treatment

Exclusion criteria

Exclusion Criteria:

  • Participant has a history of arterial or venous thromboembolism (eg, stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism) within the 6 months prior to randomization or requires current anticoagulant treatment
  • Study participant has clinically significant bleeding that warrants immediate platelet adjustment (eg, menorrhagia with significant drop in hemoglobin)
  • Study participant has a known hypersensitivity to any components of the study medication or any other anti-neonatal Fc receptor (FcRn) medications
  • Study participant has evidence of a secondary cause of immune thrombocytopenia (clear association with other medical conditions eg, of untreated H. pylori infection, leukemia, lymphoma, common variable immunodeficiency, systemic lupus erythematosus, autoimmune thyroid disease or is drug induced), participant has a multiple immune cytopenia (eg, Evan's syndrome) etc.
  • Study participant has a clinically relevant active infection (eg, sepsis, pneumonia, or abscess) in the opinion of the investigator, or had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to the first dose of investigational medicinal product (IMP)
  • Study participant with a known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent tuberculosis infection (LTBI), or current/history of nontuberculous mycobacterial infection (NTMBI)
  • Study participant has a history of a major organ transplant or hematopoietic stem cell/marrow transplant
  • Study participant has experienced intracranial bleed in the last 6 months prior to the Screening Visit
  • Study participant has a history of coagulopathy disorders other than ITP
  • Study participant with current or medical history of immunoglobulin A (IgA) deficiency, or a measurement of IgA \<50 mg/dL at the Screening Visit
  • Study participant has undergone a splenectomy in the 2 years prior to the Baseline Visit
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Rozanolixizumab

    Study participants randomized to this arm will receive fixed-unit doses of rozanolixizumab across body weight tiers at pre-specified time points during the Treatment Period. Doses will be adjusted based on platelet count values or medical needs.

    Drug: Rozanolixizumab

  • Placebo comparator
    Placebo

    Study participants randomized to this arm receive placebo at pre-specified time points during the Treatment Period.

    Other: Placebo

Interventions

  • DrugRozanolixizumab

    Study participants receive rozanolixizumab by subcutaneous infusion at pre-specified time points.

    Also known as: UCB7665

  • OtherPlacebo

    Study participants receive placebo by subcutaneous infusion at pre-specified time points.

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With Durable Clinically Meaningful Platelet Response of ≥50×10^9/L, for at Least 8 Out of 12 Weeks During the Last 12 Weeks

    Percentage of Participants With Durable Clinically Meaningful Platelet Response of ≥50×10\^9/L, for at least 8 out of 12 weeks during the last 12 weeks were reported.

    Time frame: During the last 12 weeks (Week 13 to Week 25)

Secondary outcomes

  1. Cumulative Number of Weeks With Clinically Meaningful Platelet Response of ≥50×10^9/L Over the 24-week Treatment Period

    Total number of weeks with platelet counts ≥50×10\^9/L over the 24-week Treatment Period of the study (Week 1 to Week 25) were reported.

    Time frame: Week 1 up to Week 25

  2. Time to First Clinically Meaningful Platelet Response (CMPR) of ≥50×10^9/L: Time From Starting Treatment to Achievement of First Response of ≥50×10^9/L

    Time from starting treatment to achievement of first Clinically Meaningful Platelet Response of ≥50×10\^9/L was defined as date of first clinically meaningful response - date of first treatment + 1. Median was calculated based upon the Kaplan-Meier estimate.

    Time frame: Time from starting treatment to achievement of first response of ≥50×10^9/L (up to Week 25)

  3. Percentage of Participants With Clinically Meaningful Platelet Response of ≥50×10^9/L by Day 8

    Clinically meaningful platelet response was defined as platelet count of ≥50×10\^9/L.

    Time frame: Baseline to Day 8

  4. Percentage of Participants With Response Defined as Platelet Count ≥30*10^9/L and at Least Doubling of Baseline, at Least 2 Separate Occasions at Two Adjacent Nominal Visits at Least 7 Days Apart, and Absence of Bleeding

    Response was defined as platelet count ≥30\*10\^9/L and at least doubling of baseline, at least 2 separate occasions at two adjacent nominal visits at least 7 days apart, and absence of bleeding.

    Time frame: From Baseline during Treatment Period (up to Week 25)

  5. Time to First Rescue Therapy

    Time to first rescue therapy was defined as date of first rescue therapy use - date of first treatment + 1. Median was calculated based upon the Kaplan-Meier estimate.

    Time frame: From Baseline to first rescue therapy (up to Week 25)

  6. Change From Baseline to Week 25 in Primary Immune Thrombocytopenia Patient Assessment Questionnaire (ITP-PAQ) Symptoms Score

    The ITP-PAQ Version 1 is a 44 item disease-specific Health-Related Quality of Life questionnaire developed for use in adults with chronic ITP. It includes 10 scales, Four of the scales measure physical health: Symptoms (6 items), Bother (3 items), Fatigue (4 items), and Activity (2 items). Two of the scales measure emotional health: Fear (5 items) and Psychological (5 items) Health. The remaining four scales measure other aspects of quality of life (QOL): Work QOL (4 items), Social QOL (4 items), Women's Reproductive QOL (6 items) and Overall QOL (5 items). Each item is rated on a Likert-type scale containing 4 to 7 responses. All item scores are transformed to a 0 to 100 continuum and are weighted equally to derive individual scale scores and the total score (0-100) is calculated as per the formula: Sum of item scores within the scale/raw sum range\*100. Higher scores indicate better health status.

    Time frame: From Baseline during Treatment Period (up to Week 25)

  7. Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs are defined as AEs starting after the time of first IMP administration up to and including 8 weeks (56 days) after the final dose.

    Time frame: From Baseline to end of Safety Follow-Up Period (up to Week 31)

  8. Percentage of Participants With TEAEs Leading to Withdrawal of Investigational Medicinal Product (ie, Study Discontinuation)

    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs are defined as AEs starting after the time of first IMP administration up to and including 8 weeks (56 days) after the final dose.

    Time frame: From Baseline to end of Safety Follow-Up Period (up to Week 31)

07

Results

Posted Aug 8, 2023

Participant flow

The study started to enroll study participants in June 2020 and terminated in May 2022.

Participant flow — Overall Study
MilestonePlaceboRozanolixizumab
Started1020
Completed813
Not completed27
Withdrew: Withdrawal by subject13
Withdrew: Lack of efficacy11
Withdrew: Adverse event, not fatal02
Withdrew: Covid-1901

Outcome measures

PrimaryPercentage of Participants With Durable Clinically Meaningful Platelet Response of ≥50×10^9/L, for at Least 8 Out of 12 Weeks During the Last 12 Weeks

Percentage of Participants With Durable Clinically Meaningful Platelet Response of ≥50×10\^9/L, for at least 8 out of 12 weeks during the last 12 weeks were reported.

Time frame:
During the last 12 weeks (Week 13 to Week 25)
Reported as:
Number · Percentage of participants
Percentage of Participants With Durable Clinically Meaningful Platelet Response of ≥50×10^9/L, for at Least 8 Out of 12 Weeks During the Last 12 Weeks
Percentage of participantsPlaceboRozanolixizumab
Percentage of Participants With Durable Clinically Meaningful Platelet Response of ≥50×10^9/L, for at Least 8 Out of 12 Weeks During the Last 12 Weeks05.0
SecondaryCumulative Number of Weeks With Clinically Meaningful Platelet Response of ≥50×10^9/L Over the 24-week Treatment Period

Total number of weeks with platelet counts ≥50×10\^9/L over the 24-week Treatment Period of the study (Week 1 to Week 25) were reported.

Time frame:
Week 1 up to Week 25
Reported as:
Median · Weeks
Cumulative Number of Weeks With Clinically Meaningful Platelet Response of ≥50×10^9/L Over the 24-week Treatment Period
WeeksPlaceboRozanolixizumab
Cumulative Number of Weeks With Clinically Meaningful Platelet Response of ≥50×10^9/L Over the 24-week Treatment Period0.0 (0 to 10)1.0 (0 to 18)
SecondaryTime to First Clinically Meaningful Platelet Response (CMPR) of ≥50×10^9/L: Time From Starting Treatment to Achievement of First Response of ≥50×10^9/L

Time from starting treatment to achievement of first Clinically Meaningful Platelet Response of ≥50×10\^9/L was defined as date of first clinically meaningful response - date of first treatment + 1. Median was calculated based upon the Kaplan-Meier estimate.

Time frame:
Time from starting treatment to achievement of first response of ≥50×10^9/L (up to Week 25)
Reported as:
Median · Days
Time to First Clinically Meaningful Platelet Response (CMPR) of ≥50×10^9/L: Time From Starting Treatment to Achievement of First Response of ≥50×10^9/L
DaysPlaceboRozanolixizumab
Time to First Clinically Meaningful Platelet Response (CMPR) of ≥50×10^9/L: Time From Starting Treatment to Achievement of First Response of ≥50×10^9/LNA (4.0 to NA)8.0 (5.0 to NA)
SecondaryPercentage of Participants With Clinically Meaningful Platelet Response of ≥50×10^9/L by Day 8

Clinically meaningful platelet response was defined as platelet count of ≥50×10\^9/L.

Time frame:
Baseline to Day 8
Reported as:
Number · Percentage of participants
Percentage of Participants With Clinically Meaningful Platelet Response of ≥50×10^9/L by Day 8
Percentage of participantsPlaceboRozanolixizumab
Percentage of Participants With Clinically Meaningful Platelet Response of ≥50×10^9/L by Day 810.045.0
SecondaryPercentage of Participants With Response Defined as Platelet Count ≥30*10^9/L and at Least Doubling of Baseline, at Least 2 Separate Occasions at Two Adjacent Nominal Visits at Least 7 Days Apart, and Absence of Bleeding

Response was defined as platelet count ≥30\*10\^9/L and at least doubling of baseline, at least 2 separate occasions at two adjacent nominal visits at least 7 days apart, and absence of bleeding.

Time frame:
From Baseline during Treatment Period (up to Week 25)
Reported as:
Number · Percentage of participants
Percentage of Participants With Response Defined as Platelet Count ≥30*10^9/L and at Least Doubling of Baseline, at Least 2 Separate Occasions at Two Adjacent Nominal Visits at Least 7 Days Apart, and Absence of Bleeding
Percentage of participantsPlaceboRozanolixizumab
Percentage of Participants With Response Defined as Platelet Count ≥30*10^9/L and at Least Doubling of Baseline, at Least 2 Separate Occasions at Two Adjacent Nominal Visits at Least 7 Days Apart, and Absence of Bleeding10.020.0
SecondaryTime to First Rescue Therapy

Time to first rescue therapy was defined as date of first rescue therapy use - date of first treatment + 1. Median was calculated based upon the Kaplan-Meier estimate.

Time frame:
From Baseline to first rescue therapy (up to Week 25)
Reported as:
Median · Days
Time to First Rescue Therapy
DaysPlaceboRozanolixizumab
Time to First Rescue TherapyNA (4.0 to NA)NA (46.0 to NA)
SecondaryChange From Baseline to Week 25 in Primary Immune Thrombocytopenia Patient Assessment Questionnaire (ITP-PAQ) Symptoms Score

The ITP-PAQ Version 1 is a 44 item disease-specific Health-Related Quality of Life questionnaire developed for use in adults with chronic ITP. It includes 10 scales, Four of the scales measure physical health: Symptoms (6 items), Bother (3 items), Fatigue (4 items), and Activity (2 items). Two of the scales measure emotional health: Fear (5 items) and Psychological (5 items) Health. The remaining four scales measure other aspects of quality of life (QOL): Work QOL (4 items), Social QOL (4 items), Women's Reproductive QOL (6 items) and Overall QOL (5 items). Each item is rated on a Likert-type scale containing 4 to 7 responses. All item scores are transformed to a 0 to 100 continuum and are weighted equally to derive individual scale scores and the total score (0-100) is calculated as per the formula: Sum of item scores within the scale/raw sum range\*100. Higher scores indicate better health status.

Time frame:
From Baseline during Treatment Period (up to Week 25)
Reported as:
Mean · units on a scale
Change From Baseline to Week 25 in Primary Immune Thrombocytopenia Patient Assessment Questionnaire (ITP-PAQ) Symptoms Score
units on a scalePlaceboRozanolixizumab
Change From Baseline to Week 25 in Primary Immune Thrombocytopenia Patient Assessment Questionnaire (ITP-PAQ) Symptoms Score-0.5 ± 17.04.2 ± 12.9
SecondaryPercentage of Participants With Treatment-emergent Adverse Events (TEAEs)

An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs are defined as AEs starting after the time of first IMP administration up to and including 8 weeks (56 days) after the final dose.

Time frame:
From Baseline to end of Safety Follow-Up Period (up to Week 31)
Reported as:
Number · Percentage of participants
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Percentage of participantsPlaceboRozanolixizumab
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)60.095.0
SecondaryPercentage of Participants With TEAEs Leading to Withdrawal of Investigational Medicinal Product (ie, Study Discontinuation)

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs are defined as AEs starting after the time of first IMP administration up to and including 8 weeks (56 days) after the final dose.

Time frame:
From Baseline to end of Safety Follow-Up Period (up to Week 31)
Reported as:
Number · Percentage of participants
Percentage of Participants With TEAEs Leading to Withdrawal of Investigational Medicinal Product (ie, Study Discontinuation)
Percentage of participantsPlaceboRozanolixizumab
Percentage of Participants With TEAEs Leading to Withdrawal of Investigational Medicinal Product (ie, Study Discontinuation)010.0

Adverse events

Collected over From Baseline to end of Safety Follow-Up Period (up to Week 31). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/10 (0%)1/10 (10%)6/10 (60%)
Rozanolixizumab0/20 (0%)5/20 (25%)18/20 (90%)
Most frequent serious events
Most frequent serious events
EventPlaceboRozanolixizumab
ThrombocytopeniaBlood and lymphatic system disorders1/100/20
Platelet count decreasedInvestigations1/101/20
VomitingGastrointestinal disorders0/101/20
Pneumonia viralInfections and infestations0/101/20
Head injuryInjury, poisoning and procedural complications0/101/20
Limb injuryInjury, poisoning and procedural complications0/101/20
Skin injuryInjury, poisoning and procedural complications0/101/20
HeadacheNervous system disorders0/101/20
DizzinessNervous system disorders0/101/20
UrticariaSkin and subcutaneous tissue disorders0/101/20
Most frequent other events
Showing 10 of 34
Most frequent other events
EventPlaceboRozanolixizumab
HeadacheNervous system disorders2/1012/20
PyrexiaGeneral disorders0/106/20
NauseaGastrointestinal disorders0/103/20
AnaemiaBlood and lymphatic system disorders0/102/20
HypofibrinogenaemiaBlood and lymphatic system disorders1/100/20
Eye painEye disorders1/100/20
DiarrhoeaGastrointestinal disorders0/102/20
Gingival bleedingGastrointestinal disorders0/102/20
Abdominal painGastrointestinal disorders1/101/20
ConstipationGastrointestinal disorders1/101/20

Baseline characteristics

Baseline Characteristics refer to Randomized Set which consisted of all enrolled study participants who were randomized.

Age, Categorical
Age, Categorical(Participants)PlaceboRozanolixizumabTotal
<=18 years011
Between 18 and 65 years101727
>=65 years022
Age, Continuous
Age, Continuous(years)PlaceboRozanolixizumabTotal
Mean41.9 ± 14.542.3 ± 15.742.2 ± 15.0
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboRozanolixizumabTotal
Female61319
Male4711
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)PlaceboRozanolixizumabTotal
Asian369
White71320
Missing011
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)PlaceboRozanolixizumabTotal
Hispanic or Latino022
Not Hispanic or Latino101828
Missing000
Platelet count
Platelet count(cells*10^9/L)PlaceboRozanolixizumabTotal
Mean14.10 ± 7.7714.65 ± 8.1814.46 ± 7.91
08

Study locations

29 sites
  • Tp0006 50412
    St. Petersburg, Florida 33709, United States
  • Tp0006 50243
    Boston, Massachusetts 02114, United States
  • Tp0006 40189
    Plovdiv, Bulgaria
  • Tp0006 40008
    Sofia, Bulgaria
  • Tp0006 20201
    Bengbu, China
  • Tp0006 20189
    Changchun, China
  • Tp0006 20188
    Changsha, China
  • Tp0006 20186
    Changzhou, China
  • Tp0006 20179
    Fuzhou, China
  • Tp0006 20187
    Hangzhou, China
  • Tp0006 20177
    Jinan, China
  • Tp0006 20185
    Jinan, China
  • Tp0006 20194
    Wuxi, China
  • Tp0006 40364
    Lille, France
  • Tp0006 40369
    Berlin, Germany
  • Tp0006 40366
    Rostock, Germany
  • Tp0006 40219
    Słupsk, Poland
  • Tp0006 40223
    Warsaw, Poland
  • Tp0006 20052
    Moscow, Russia
  • Tp0006 20054
    Moscow, Russia
  • Tp0006 20053
    Saint Petersburg, Russia
  • Tp0006 40231
    Madrid, Spain
  • Tp0006 40268
    Madrid, Spain
  • Tp0006 40381
    Zaragoza, Spain
  • Tp0006 20094
    Tainan, Taiwan
  • Tp0006 20095
    Taipei, Taiwan
  • Tp0006 20061
    Cherkasy, Ukraine
  • Tp0006 20064
    Kyiv, Ukraine
  • Tp0006 40239
    Leeds, United Kingdom
09

References and documents

Study documents

  • Study protocol · Dec 6, 2021
  • Statistical analysis plan · Aug 16, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.

Access criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.

Data sharing details ↗ · www.vivli.org

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2020 to primary completion in Apr 2022, 22 months.

Results were first posted in Aug 2023, 1 year 3 months after primary completion. A results delay was requested in Dec 2022.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 8, 2020
First posted
Jan 13, 2020
StartActual
Jun 3, 2020
Primary completionActual
Apr 25, 2022
CompletionActual
May 5, 2022
Results delay requested
Dec 19, 2022
Results first posted
Aug 8, 2023
Last update
Aug 8, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04224688
Lead sponsor
UCB Biopharma SRL
Responsible party
Sponsor
First posted
Jan 13, 2020
Start date
Jun 3, 2020
Primary completion
Apr 25, 2022
Completion
May 5, 2022
Results posted
Aug 8, 2023
Last update
Aug 8, 2023

Study contacts

UCB Cares
study director · 001 844 599 2273

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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