A Study of JNJ-64304500 in Participants With Alopecia Areata

Janssen (J&J Innovative Medicine)

Status and phase: Withdrawn; Phase 2

Conditions: Alopecia Areata

Treatments: Drug: JNJ-64304500; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04740970

2020-004500-34 (EudraCT Number)

64304500ALA2001 (Other Identifier)

CR108941

Details and patient eligibility

About

The purpose of this study is to evaluate the clinical response of 22 weeks of study intervention with JNJ-64304500, compared with placebo, in participants with moderate to severe alopecia areata (AA).

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Participant has a physician confirmed diagnosis of moderate to severe Alopecia Areata (AA) (greater than or equal to [>=] 50 percent [%] scalp involvement) as measured using the severity of Alopecia tool (SALT) score; or participant has >=95% loss of scalp hair for enrollment as alopecia totalis (AT) or alopecia universalis (AU) subtypes at the time of screening and baseline
• Current episode of hair loss is greater than (>) 6 months (without evidence of spontaneous terminal hair regrowth within 6 months at the time of screening and baseline), but less than or equal to (<=8) years
• Medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at either screening or Week 0. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator
• Medically stable on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel or hematology are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator

Key Exclusion Criteria:

• History of liver or renal insufficiency (estimated creatinine clearance below 60 milliliters per minute (mL/min)); significant cardiac, vascular, pulmonary, gastrointestinal, endocrine (except stable thyroid diseases), neurologic, hematologic, rheumatologic, psychiatric disorders, or metabolic disturbances
• Currently has a malignancy or has a history of malignancy (with the exceptions of participants having adequately treated and cured basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ occurring more than 5 years prior to randomization)
• Known allergies, hypersensitivity, or intolerance to JNJ-64304500 or its excipients
• Participants with current episode of hair loss for >8 years
• Has previous treatment with an oral janus kinase (JAK) inhibitor

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

JNJ-64304500

Experimental group

Description:

Participants will receive JNJ-64304500 dose 1 subcutaneous (SC) injection at Week 0 and then dose 2 SC injection every 2 weeks from Week 2 through Week 22.

Treatment:

Drug: JNJ-64304500

Placebo

Placebo Comparator group

Description:

Participants will receive matching placebo SC injection at Week 0 and then every 2 weeks from Week 2 through Week 22.

Treatment:

Drug: Placebo