A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants (MOMENTUM)

Inclusion Criteria:

• Age >= 18 years.
• Confirmed diagnosis of PMF in accordance with the World Health Organization (WHO) 2016criteria, or Post- polycythemia vera/essential thrombocythemia (PV/ET) MF inaccordance with the International Working Group-Myeloproliferative Neoplasms Researchand Treatment (IWG-MRT criteria).
• Symptomatic, defined as a TSS of >= 10 units assessed by a single MFSAF v4.0assessment during Screening prior to Baseline period (Day BL1).
• Anemic, defined as a Hgb < 10 g/dL in Screening/Baseline period.
• Previously treated with an approved JAK inhibitor for PMF or Post-PV/ET MF for >= 90days, or >= 28 days if JAK inhibitor therapy is complicated by RBC transfusionrequirement of >= 4 units in 8 weeks, or Grade 3/4 AEs of thrombocytopenia, anemia, orhematoma.
• Baseline splenomegaly, defined as having a palpable spleen at >= 5 centimeter (cm),below the left costal margin, or with volume >= 450 cubic centimeter (cm^3) on imaging (ultrasound, magnetic resonance imaging [MRI] or computed tomography [CT] areacceptable), assessed during Screening at any point prior to Randomization.
• High risk, intermediate-2, or intermediate-1 risk MF as defined by DynamicInternational Prognostic Scoring System (DIPSS), or DIPSS-plus.
• No allogeneic stem cell transplant planned.
• Acceptable laboratory assessments:

1. Absolute neutrophil count (ANC) >= 0.75 × 10^9/Liter (L).
2. Platelet count (PLT) >= 25 × 10^9/L (without requirement for platelettransfusion).
3. Peripheral blast count < 10%.
4. Alanine aminotransferase/ glutamic-oxaloacetic transaminase (AST/SGOT) andalanine aminotransferase/ serum glutamic-pyruvic transaminase (ALT/SGPT) <= 3 ×Upper Limit Normal (ULN) (<= 5 × ULN if liver is involved by extramedullaryhematopoiesis as judged by the investigator or if related to iron chelatortherapy that was started within the prior 60 days).
5. Calculated creatinine clearance (CCr) >= 30 milliliter per minute (mL/min)according to Cockcroft-Gault.
6. Direct bilirubin <= 2.0 × ULN.

Exclusion Criteria:

• Use of the following treatments within the time periods noted:

1. Prior momelotinib treatment at any time.
2. Approved JAK inhibitor therapy (eg, fedratinib or ruxolitinib) within 1 weekprior to the first day of Baseline.
3. Active anti-MF therapy within 1 week prior to the first day of Baseline.
4. Potent Cytochrome P450 3A4 (CYP3A4) inducers within 1 week prior toRandomization.
5. Investigational agent (including investigational JAK inhibitors) within 4 weeksprior to Randomization.
6. Erythropoiesis stimulating agent (ESA) within 4 weeks prior to Randomization.
7. Danazol within 3 months prior to Randomization.
8. Splenic irradiation within 3 months prior to Randomization.
9. Current treatment with simvastatin, atorvastatin, lovastatin or rosuvastatin.

• History of prostate cancer, with the exception of localized prostate cancer that hasbeen treated surgically or by radiotherapy with curative intent and presumed cured.
• Prostate specific antigen (PSA) > 4 nanograms per milliliter (ng/mL).
• Unsuitable for spleen volume measurements due to prior splenectomy or unwilling orunable to undergo an MRI scan or CT scan for spleen volume measurement per protocolrequirements.
• Any of the following (criteria a - k):

1. Uncontrolled intercurrent illness including, but not limited to: activeuncontrolled infection (participants receiving outpatient antibacterial and/orantiviral treatments for infection that is under control or as infectionprophylaxis may be included in the trial).
2. Significant active or chronic bleeding event >= Grade 2 per Common TerminologyCriteria for Adverse Events (CTCAE) v5.0, within 4 weeks prior to Randomization.
3. Unstable angina pectoris within 6 months prior to Randomization.
4. Symptomatic congestive heart failure within 6 months prior to Randomization.
5. Uncontrolled cardiac arrhythmia within 6 months prior to Randomization.
6. QT Interval Corrected Using Fridericia's Formula (QTcF) interval > 500millisecond (msec), unless attributed to bundle branch block.
7. Current progressive thrombosis despite treatment.
8. History of porphyria.
9. Child-Pugh score >= 10.
10. Psychiatric illness, social situation, or any other condition that would limitcompliance with trial requirements or may interfere with the interpretation ofstudy results, as judged by investigator or sponsor.
11. Inability or unwillingness to comply with the protocol restrictions on MF therapyand other medications prior to and during study treatment.

• Participants with a prior or concurrent malignancy, whose natural history or treatmenthas a significant potential to interfere with the safety or efficacy assessment of theinvestigational regimen.
• Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies,or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding orthalassemia.
• Known positive status for human immunodeficiency viruses (HIV).
• Chronic active or acute viral hepatitis A, B, or C infection, or hepatitis B or Ccarrier (testing required for hepatitis B and C).
• Unresolved non-hematologic toxicities from prior therapies that are > Grade 1 perCTCAE v5.0.
• Presence of peripheral neuropathy >= Grade 2 per CTCAE v5.0.
• Women who are already pregnant or lactating. Additional inclusion/exclusion criteriamay apply.