A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared with Placebo Added to Standard of Care in Adult Participants with Polymyositis - JASMINE

Study identifier:D3463C00003

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Will Be Recruiting

Official Title

A Multicenter, Parallel-group, Double-blind, 2-Arm, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared with Placebo Added to Standard of Care in Adult Participants with Polymyositis

Medical condition

Polymyositis

Phase

Phase 3

Healthy volunteers

Study drug

Anifrolumab

Sex

All

Estimated Enrollment

162

Study type

Interventional

Age

18 Years - 70 Years

Date

Study Start Date: 15 Nov 2023

Estimated Primary Completion Date: 23 Apr 2026

Estimated Study Completion Date: 26 Jan 2027

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2023 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

1 18 -70 years old.
2 Body weight ≥ 40 kg.
3 Must have “probable” or “definite” diagnosis of PM according to the 2017 ACR/EULAR classification criteria for adult myositis.
4 Fulfill criteria of active disease at screening:
5 Currently receiving a stable dose of standard of care (SOC) background medications at time of enrollment
6 Females who have been or are sexually active with an intact cervix must have documentation of a cervical cancer screening with a normal test result within 2 years prior to Day 1.
7 No medical history or signs or symptoms of active TB prior to or during the screening period.
8 Females of non child-bearing potential if postmenopausal or surgically sterilized.
9 Females of child-bearing potential and males considered fertile after puberty who are sexually active must use contraception.

Exclusion Criteria

1 Participants with documented DM, IBM, IMNM, juvenile myositis, drug-induced myositis, cancer associated myositis and non inflammatory myopathies, fibromyalgia or with muscle symptoms that may interfere with study efficacy assessments.
2 Wheelchair-bound within 3 months prior to Day 1.
3 Signs of severe uncontrolled extra-muscular disease damage related to PM within 6 months prior to Day 1.
4 Severe muscle damage.
5 Permanent weakness due to a non-PM cause.
6 History of suicidal ideation within 6 months prior to signing the ICF, or any suicidal behaviour within 12 months prior to signing the ICF or recurrent suicidal behaviour in the lifetime of the participant.
7 Any severe case of herpes zoster infection.
8 History of cancer.
9 History of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection.
10 Positive test result for HIV antibody or infection at screening.
11 Positive test result for hepatitis B serology at screening.
12 Active hepatitis C infection at screening.
13 Any clinical cytomegalovirus or Epstein-Barr virus infection that has not resolved within 12 weeks prior to signing the ICF.
14 Infection requiring hospitalization or IV antimicrobial treatment within 3 years prior to Day 1.
15 Chronic infection within 8 weeks prior to signing the ICF.
16 Infection requiring hospitalization or treatment with IV anti-infective medications not completed at least 4 weeks prior to signing the ICF.
17 Infection requiring oral anti-infective medications within 2 weeks prior to Day 1.
18 COVID-19 infection criteria:
(a) History of severe COVID-19 infection or prior COVID-19 infection with long COVID and/or unresolved sequelae.
(b) Mild/asymptomatic COVID-19 infection within 6 weeks prior to Day 1.
19 History of allergy or reaction to any component of the study intervention formulation or history of anaphylaxis to human gamma globulin therapy, human proteins or monoclonal antibodies.
20 Prior receipt of anifrolumab.
21 Change in route of administration of oral, SC, or IM methotrexate anytime within 8 weeks prior to signing the ICF.
22 Receipt of commercially available biologic agent within 5 half-lives prior to signing the ICF.
23 Receipt of prohibited medications if the required discontinuation or washout time prior to ICF signing is not met.
24 Receipt of any of the following:
(a) Intra-articular, IM, or IV glucocorticosteroids within 4 weeks prior to Day 1.
(b) Live or attenuated vaccine within 8 weeks prior to signing the ICF.
(c) Blood transfusion or receipt of blood products within 4 weeks prior to signing the ICF.
25 Cannabinoid use that is not at a stable regimen for at least 8 weeks prior to signing the ICF.
26 Receipt of > 2 investigational products for the disease under study.
27 Receipt of any investigational product, including licensed drugs that are not approved for the treatment of myositis within 4 weeks or 5 half-lives prior to signing the ICF, whichever is longer.
28 Concurrent enrollment in clinical study with an investigational product.
29 Certain abnormal laboratory results at screening.
30 Lactating, breastfeeding, or pregnant females from initiation of screening until 16 weeks following the final dose of study intervention.
31 Spontaneous or induced abortion, still or live birth, or pregnancy ≤ 4 weeks prior to signing the ICF.
32 Any condition that would interfere with efficacy or safety evaluation of the study intervention or put the participant at safety risk.
33 Alcohol, drug, or chemical abuse within 1 year prior to Day 1.
34 Major surgery from 8 weeks prior to signing the ICF to end of study.
35 Individuals involved in the planning and/or conduct of the study, their employees, or immediate family members of such individuals.
36 Previous randomization in the present study.

No locations available

Arms	Assigned Interventions
Experimental: Anifrolumab Anifrolumab	Drug: Anifrolumab Anifrolumab
Placebo Comparator: Placebo Placebo	Other: Placebo Placebo

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]