Relapsing Multiple SclerosisPhase 2NCT06104683
A Study of Pirtobrutinib (LY3527727 [LOXO-305]) Versus Placebo in Participants With Relapsing Multiple Sclerosis
A Phase 2 study testing Pirtobrutinib in people with Relapsing Multiple Sclerosis and Multiple Sclerosis, run by Loxo Oncology, Inc. at 4 sites in 2 countries.
Trial summary
The main purpose of this study is to assess efficacy and safety of pirtobrutinib in participants with relapsing multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing Multiple Sclerosis, Multiple Sclerosis
- What is being tested?
- Pirtobrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 May 2024to 13 Feb 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants must have been diagnosed with relapsing MS
- Participants must have one of the following
- at least 1 documented relapse within the previous year, or
- at least 2 documented relapse within the previous 2 years, or
- at least 1 active Gd-enhancing brain lesion on an MRI scan in the past 6 months prior to screening.
Who cannot join
- Have had a diagnosis of primary progressive MS
- Have a history of another clinically significant neurological disease
- Had a relapse of MS within 30 days prior to randomization.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Clinical Trial Network
Houston, Texas, 77074
Swedish Medical Center-501 E Hampden Ave
Seattle, Washington, 98122-5698
University of South Florida
Tampa, Florida, 33612
Puerto Rico1 site
Caribbean Center For Clinical Research Inc
Guaynabo, 969
About this study
Official title: A Phase 2, Randomized Study of Pirtobrutinib Versus Placebo in Patients With Relapsing Multiple Sclerosis
The main purpose of this study is to assess efficacy and safety of pirtobrutinib in participants with relapsing multiple sclerosis.
- Conditions
- Relapsing Multiple Sclerosis, Multiple Sclerosis
- Being tested
- Placebo, Pirtobrutinib
- Keywords
- Relapsing Forms Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Administered orally
PirtobrutinibDrug
Also called LY3527727
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Pirtobrutinib Dose 1 | Experimental | Participants will receive pirtobrutinib orally. Receives: Drug: Pirtobrutinib |
| Pirtobrutinib Dose 2 | Experimental | Participants will receive pirtobrutinib orally. Receives: Drug: Pirtobrutinib |
| Pirtobrutinib Dose 3 | Experimental | Participants will receive pirtobrutinib orally. Receives: Drug: Pirtobrutinib |
| Placebo | Placebo comparator | Participants will receive placebo orally. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
New T1 Gadolinium (Gd)-enhancing Lesions on Brain Magnetic Resonance Imaging (MRI) Per Scan
Measured: Week 8 and Week 12
Number of New and/or Enlarging T2 Lesions
Measured: Week 12
Secondary outcomes (3)
Total Number of T1 Gd-Enhancing Lesions Per Scan
Measured: Week 8 and Week 12
Total Number of Gd-Enhancing Lesions Per Scan
Measured: Week 8 and Week 12
Pharmacokinetics (PK): Plasma Concentration of Pirtobrutinib
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 May 2024 (estimated)
- Primary completion16 Jan 2026 (estimated)
- Study completion13 Feb 2026 (estimated)
Why it stopped: Sponsor Decision: The trial has been withdrawn with no plans to continue development.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Multiple 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loxo Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104683
- Sponsor's protocol ID
- 18690
- Other IDs
- J2N-MC-KLAA, 2022-502376-24-00
- Status last verified
- Mar 2024
- First submitted
- 24 Oct 2023
- Last updated
- 27 Mar 2024
- Results posted
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized Study of Pirtobrutinib Versus Placebo in Patients With Relapsing Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06104683
- Acronym / sponsor ID
- 18690
- Conditions
- Relapsing Multiple Sclerosis, Multiple Sclerosis
- Keywords
- Relapsing Forms Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor Decision: The trial has been withdrawn with no plans to continue development.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Loxo Oncology, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 16 Jan 2026 (estimated)
- Study completion
- 13 Feb 2026 (estimated)
- First posted
- 27 Oct 2023 (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.
The main purpose of this study is to assess efficacy and safety of pirtobrutinib in participants with relapsing multiple sclerosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pirtobrutinib Dose 1 | Experimental | Drug: PirtobrutinibParticipants will receive pirtobrutinib orally. |
| Pirtobrutinib Dose 2 | Experimental | Drug: PirtobrutinibParticipants will receive pirtobrutinib orally. |
| Pirtobrutinib Dose 3 | Experimental | Drug: PirtobrutinibParticipants will receive pirtobrutinib orally. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo orally. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants must have been diagnosed with relapsing MS
- Participants must have one of the following
Key exclusion criteria (3 listed)
- Have had a diagnosis of primary progressive MS
- Have a history of another clinically significant neurological disease
- Had a relapse of MS within 30 days prior to randomization.
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 |
|---|---|---|
| PlaceboAdministered orally | Drug | Placebo |
| PirtobrutinibAlso: LY3527727Administered orally | Drug | Pirtobrutinib Dose 1, Pirtobrutinib Dose 2, Pirtobrutinib Dose 3 |
Primary outcome
New T1 Gadolinium (Gd)-enhancing Lesions on Brain Magnetic Resonance Imaging (MRI) Per Scan
Time frame: Week 8 and Week 12
Number of New and/or Enlarging T2 Lesions
Time frame: Week 12
3 secondary outcomes
Total Number of T1 Gd-Enhancing Lesions Per Scan
Time frame: Week 8 and Week 12
Total Number of Gd-Enhancing Lesions Per Scan
Time frame: Week 8 and Week 12
Pharmacokinetics (PK): Plasma Concentration of Pirtobrutinib
Time frame: Baseline to Week 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Individual participant dataSharing planned: 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.
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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.
1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pirtobrutinib in people with Relapsing Multiple Sclerosis and Multiple Sclerosis, run by Loxo Oncology, Inc. at 4 sites in 2 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 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: withdrawn, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Puerto Rico. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
New T1 Gadolinium (Gd)-enhancing Lesions on Brain Magnetic Resonance Imaging (MRI) Per Scan (time frame: Week 8 and Week 12). The study lists 2 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 27 Mar 2024.