A Study of Pirtobrutinib (LY3527727 [LOXO-305]) Versus Placebo in Participants With Relapsing Multiple Sclerosis

Loxo Oncology

Status and phase: Withdrawn; Phase 2

Conditions: Multiple Sclerosis; Relapsing Multiple Sclerosis

Treatments: Drug: Pirtobrutinib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06104683

2022-502376-24-00 (Other Identifier)

J2N-MC-KLAA (Other Identifier)

18690

Details and patient eligibility

About

The main purpose of this study is to assess efficacy and safety of pirtobrutinib in participants with relapsing multiple sclerosis.

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have been diagnosed with relapsing MS

• Participants must have one of the following

  1. at least 1 documented relapse within the previous year, or
  2. at least 2 documented relapse within the previous 2 years, or
  3. at least 1 active Gd-enhancing brain lesion on an MRI scan in the past 6 months prior to screening.

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

0 participants in 4 patient groups, including a placebo group

Pirtobrutinib Dose 1

Experimental group

Description:

Participants will receive pirtobrutinib orally.

Treatment:

Drug: Pirtobrutinib

Pirtobrutinib Dose 2

Experimental group

Description:

Participants will receive pirtobrutinib orally.

Treatment:

Drug: Pirtobrutinib

Pirtobrutinib Dose 3

Experimental group

Description:

Participants will receive pirtobrutinib orally.

Treatment:

Drug: Pirtobrutinib

Placebo

Placebo Comparator group

Description:

Participants will receive placebo orally.

Treatment:

Drug: Placebo