A Phase 2 Study to Investigate Efficacy and Safety of HZN-1116 in Participants With Sjogren's Syndrome

Amgen

Status and phase: Enrolling; Phase 2

Conditions: Sjogren's Syndrome

Treatments: Drug: HZN-1116; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06312020

HZNP-HZN-1116-201

Details and patient eligibility

About

The purpose of this study is to measure the efficacy and safety of HZN-1116 in participants with Sjogren's syndrome (SS).

Full description

The study will enroll 2 SS populations: Population 1 will include participants with moderate to high systemic disease activity; Population 2 will include participants with moderate to severe subjective symptoms. This study will include 3 periods: screening (5 weeks), treatment period (48 Weeks) and follow-up period (12 weeks). In the treatment period, participants from each of the populations will be randomized to receive subcutaneous (SC) dose of HZN-1116 or placebo.

Acquired from Horizon in 2024.

Enrollment: 262 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Diagnosed with SS by meeting the 2016 American College of Rheumatology (ACR)/EULAR Classification Criteria.
• Have an ESSDAI score of >= 5 at screening (only for Population 1).
• Have an ESSPRI score of >= 5 at screening (only for Population 2).
• Have an ESSDAI score of < 5 at screening (only for Population 2).
• Positive for anti-Ro autoantibodies, rheumatoid factor (RF) at screening, or both at screening.

Key Exclusion Criteria:

• Concomitant system sclerosis.
• Active malignancy or history of malignancy within the last 5 years with exception of in situ carcinoma of the cervix treated with apparent success with curative therapy > 12 months prior to screening; OR cutaneous basal cell carcinoma following presumed curative therapy.
• Individuals who are pregnant or lactating or planning to become pregnant during the study.
• Individuals who have a positive test for, or have been treated for, hepatitis B, hepatitis C, or HIV infection.
• Individuals with history of more than one episode of herpes zoster and/or opportunistic infections in the last 12 months, with the exception of non-invasive herpes simplex at any site, oral candidiasis, vaginal candidiasis, or cutaneous fungal infections, which are permitted within the prior 12 months unless of unusual severity. Individuals with a prior history of ophthalmic herpes zoster will be excluded.
• Active infections requiring systemic treatment at the time of screening or through randomization, or history of more than 2 infections requiring intravenous (IV) antibiotics within 12 months prior to screening.
• Last administration of experimental biologic or oral agents < 6 months or 5 half-lives, whichever is longer, before screening.
• Individuals who have had previous treatment with any biologic B cell-depleting therapy (eg, rituximab, ocrelizumab, inebilizumab, or ofatumumab) within 12 months or other B cell targeting therapy (eg, belimumab) or anti-type I IFN pathway therapy (eg, anifrolumab) < 6 months before randomization.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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262 participants in 8 patient groups, including a placebo group

HZN-1116 Dose 1 in Population 1

Experimental group

Description:

Participants will receive Dose 1 of HZN-1116

Treatment:

Drug: HZN-1116

HZN-1116 Dose 2 in Population 1

Experimental group

Description:

Participants will receive Dose 2 of HZN-1116

Treatment:

Drug: HZN-1116

Placebo in Population 1

Placebo Comparator group

Description:

Participants will receive Placebo matched to HZN-1116

Treatment:

Drug: Placebo

HZN-1116 Dose 1 in Population 2

Experimental group

Description:

Participants will receive Dose 1 of HZN-1116

Treatment:

Drug: HZN-1116

HZN-1116 Dose 2 in Population 2

Experimental group

Description:

Participants will receive Dose 2 of HZN-1116

Treatment:

Drug: HZN-1116

HZN-1116 Dose 3 in Population 2

Experimental group

Description:

Participants will receive Dose 3 of HZN-1116

Treatment:

Drug: HZN-1116

HZN-1116 Dose 4 in Population 2

Experimental group

Description:

Participants will receive Dose 4 of HZN-1116

Treatment:

Drug: HZN-1116

Placebo in Population 2

Placebo Comparator group

Description:

Participants will receive Placebo matched to HZN-1116

Treatment:

Drug: Placebo