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Chronic Spontaneous UrticariaPhase 2NCT04159701

A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria

A Phase 2 study testing LY3454738 in people with Chronic Spontaneous Urticaria, run by Eli Lilly and Company at 25 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The reason for this study is to see if the study drug LY3454738 is safe and effective as treatment for participants with hives that are caused by chronic spontaneous urticaria (CSU) and that are not controlled with H1-antihistamines. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Spontaneous Urticaria
What is being tested?
LY3454738
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
52 participants
Where
25 sitesin 3 countries
Study dates
15 Nov 2019to 24 Feb 2021
Phase
Phase 2
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must agree to use appropriate birth control throughout the study
  • Must have a diagnosis of CSU for at least 6 months
  • Must have CSU symptoms for at least 8 consecutive weeks despite taking anti-histamines
  • Must agree to take an anti-histamine every day during the trial
  • Must be willing to enter information about symptoms in an electronic diary twice a day

Who cannot join

  • Must not have a cause, other than CSU, for itching, hives, and/or angioedema (swelling beneath the skin)
  • Must not have a current or recent active infection requiring antibiotics
  • Must not have a history of anaphylaxis (severe, life threatening allergic reaction)
  • Must not have asthma requiring medications other than short acting beta agonists (albuterol, etc.)
  • Must not have received prior treatment with omalizumab, ligelizumab, or other experimental biologic for CSU

Trial locations and contacts

25 sites in 3 countries.

25 sites in 3 countries

United States18 sites

  • Florida Center for Allergy & Asthma Research Landman

    Aventura, Florida, 33180

  • Kern Research, Inc

    Bakersfield, California, 93301

  • Johns Hopkins Asthma and Allergy Center

    Baltimore, Maryland, 21224

  • Treasure Valley Medical Research

    Boise, Idaho, 83706

  • Optimed Research, LTD

    Columbus, Ohio, 43235

  • First OC Dermatology

    Fountain Valley, California, 92708

  • Antelope Valley Clinical Trials

    Lancaster, California, 93534

  • California Allergy and Asthma Medical Group + Research Center

    Los Angeles, California, 90025

  • Florida Center for Allergy & Asthma Research Rodicio

    Miami, Florida, 33173

  • Miami Dermatology and Laser Research

    Miami, Florida, 33173

  • Allergy & Asthma Specialists, P.S.C.

    Owensboro, Kentucky, 42301

  • Northwest Research Center

    Portland, Oregon, 97202

  • Allergy & Asthma Consultants

    Redwood City, California, 94063

  • Sarasota Clinical Research

    Sarasota, Florida, 34239

  • Signature Allergy & Immunology

    St Louis, Missouri, 63141

  • ForCare Clinical Research

    Tampa, Florida, 33613-1244

  • University of South Florida Asthma, Allergy and Immunology

    Tampa, Florida, 33613

  • Vital Prospects Clinical Research Institute, P.C.

    Tulsa, Oklahoma, 74136

Other trials in United States

Germany5 sites

  • Charité Campus Virchow-Klinikum

    Berlin, 10117

  • Rothhaar Studien GmbH

    Berlin, 10783

  • Medizinische Hochschule Hanover

    Hanover, Lower Saxony, 30625

  • Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

    Mainz, Rhineland-Palatinate, 55131

  • Universitätsklinikum Münster

    Münster, North Rhine-Westphalia, 48149

Other trials in Germany

Poland2 sites

  • Diamond Clinic

    Krakow, Lesser Poland Voivodeship, 31-559

  • Centrum Medyczne Evimed

    Warsaw, Masovian Voivodeship, 02-625

Other trials in Poland

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Crossover Study to Evaluate the Efficacy and Safety of LY3454738 in Adults With Chronic Spontaneous Urticaria Inadequately Controlled With H1-Antihistamines

The reason for this study is to see if the study drug LY3454738 is safe and effective as treatment for participants with hives that are caused by chronic spontaneous urticaria (CSU) and that are not controlled with H1-antihistamines.

Being tested
LY3454738, Placebo
Medical subject headings
Chronic Urticaria

What participants receive

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

  • LY3454738Drug

    Administered IV

  • PlaceboDrug

    Administered IV

Study groups in NCT04159701
Study groupRoleWhat they receive
LY3454738Experimental500 milligram (mg) LY3454738 administered intravenously (IV).
Receives: Drug: LY3454738
PlaceboPlacebo comparatorPlacebo administered IV.
Receives: Drug: Placebo

What is being measured

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

  1. Mean Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7)

    The UAS7 is the sum of the daily urticaria activity scores (UAS) over a 7-day period and ranges from 0 to 42. The daily UAS is the sum of the daily itch severity score (ISS) and daily number of hives score, and ranges from 0 to 6. The baseline UAS7 is the sum of the daily UAS over the 7 days prior to the first treatment. A higher UAS or higher UAS7 indicates greater urticaria disease activity.The ANCOVA model includes treatment as a factor and baseline UAS7 score in First 12-Week treatment period as covariates. Missing Week 12 scores will be imputed by carrying forward the participants' baseline scores (BOCF).

    Measured: Baseline, Week 12

Secondary outcomes (6)

  1. Mean Change From Baseline in Itch Severity Score Over 7 Days (ISS7)

    The ISS7 is the sum of the daily ISS over a 7-day period and ranges from 0 to 21. The daily ISS is the average of the morning and evening ISS on a 4-point scale of 0 (none), 1 (mild), 2 (moderate), and 3 (severe). The baseline ISS7 is the sum of the daily ISS over the 7 days prior to the first treatment. A higher ISS or higher ISS7 indicates more severe itching. The ANCOVA model includes treatment as a factor and baseline UAS7 score in First 12-Week treatment period as covariates. Missing Week 12 scores will be imputed by carrying forward the participants' baseline scores (BOCF).

    Measured: Baseline, Week 12

  2. Mean Change From Baseline in Hives Severity Score Over 7 Days (HSS7)

    The HSS7 is the sum of the daily number of hives over a 7-day period and ranges from 0 to 21. The daily number of hives score (also called HSS) is the average of the morning and evening number of hive scores on a four-point scale of 0 (none), 1 (between 1 and 6 hives, inclusive), 2 (between 7 and 12 hives, inclusive), and 3 (greater than 12 hives). The baseline weekly HSS7 is the sum of the HSS over the 7 days prior to the first treatment. A higher HSS or higher HSS7 indicates a greater number of hives. The ANCOVA model includes treatment as a factor and baseline UAS7 score in First 12-Week treatment period as covariates. Missing Week 12 scores will be imputed by carrying forward the participants' baseline scores (BOCF).

    Measured: Baseline, Week 12

  3. Percentage of Participants Achieving Urticaria Activity Score Over 7 Days (UAS7) ≤6 (Stratified by Baseline UAS7 (< 28 vs >= 28) Score)

    The UAS7 is the sum of the daily urticaria activity scores (UAS) over a 7-day period and ranges from 0 to 42. The daily UAS is the sum of the daily itch severity score (ISS) and daily number of hives score, and ranges from 0 to 6. The baseline UAS7 is the sum of the daily UAS over the 7 days prior to the first treatment. A higher UAS or higher UAS7 indicates greater urticaria disease activity.

    Measured: Week 12

  4. Percentage of Participants Achieving Urticaria Activity Score Over 7 Days (UAS7) ≤6 (Stratified by Baseline UAS7 (< Median vs >= Median) Score)

    The UAS7 is the sum of the daily urticaria activity scores (UAS) over a 7-day period and ranges from 0 to 42.The daily UAS is the sum of the daily itch severity score (ISS) and daily number of hives score, and ranges from 0 to 6. The baseline UAS7 is the sum of the daily UAS over the 7 days prior to the first treatment. A higher UAS or higher UAS7 indicates greater urticaria disease activity.

    Measured: Week 12

  5. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 336 Hours (AUC [0-336h]) of LY3454738

    Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 336 Hours (AUC [0-336h]) of LY3454738

    Measured: Before Infusion, after infusion, 1 hour after infusion and 2 hours after infusion on Day 1; Before Infusion on Day 8, 15, 29, 43, 57, 71, 85, 92, 99, 113, 127, 141, 155, 169 and Post-Treatment Follow-up

  6. PK: Maximum Concentration (Cmax) of LY3454738

    PK: Maximum Concentration (Cmax) of LY3454738

    Measured: Before Infusion, after infusion, 1 hour after infusion and 2 hours after infusion on Day 1; Before Infusion on Day 8, 15, 29, 43, 57, 71, 85, 92, 99, 113, 127, 141, 155, 169 and Post-Treatment Follow-up

Timeline

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

  1. First posted12 Nov 2019
  2. Study start15 Nov 2019
  3. Primary completion24 Feb 2021
  4. Study completion24 Feb 2021

Why it stopped: The study was terminated for lack of efficacy after an interim analysis was performed

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04159701
Sponsor's protocol ID
17480
Other IDs
J1B-MC-FRCF, 2019-002495-13, 2019
Status last verified
Feb 2022
First submitted
8 Nov 2019
Last updated
11 Mar 2022
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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY3454738 in people with Chronic Spontaneous Urticaria, run by Eli Lilly and Company at 25 sites in 3 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 5 inclusion and 5 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 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States, Germany, Poland. 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 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?

Yes. Results are posted in the registry (first posted 11 Mar 2022). 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?

Mean Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7) (time frame: Baseline, Week 12). 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 NCT04159701.

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 11 Mar 2022.

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