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A Phase 3 Clinical Study of KHK 4827

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Kyowa Kirin

Status and phase

Completed
Phase 3

Conditions

Pustular; Psoriasis, Palmaris Et Plantaris
Psoriatic Arthritis
Psoriatic Erythroderma
Psoriasis Vulgaris

Treatments

Drug: KHK4827 210mg SC
Drug: KHK4827 140mg SC

Study type

Interventional

Funder types

Industry

Identifiers

NCT02052609
4827-005

Details and patient eligibility

About

This study is designed to evaluate the safety and efficacy of long-term exposure to KHK4827 in subjects with plaque psoriasis (psoriasis vulgaris, psoriatic erythroderma) who have completed Study 4827-003 (Study 003)and in subjects with pustular psoriasis (generalized) or psoriatic erythroderma who have completed the Study 4827-004 (Study 004).

Enrollment

155 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subject has voluntarily signed the written informed consent form to participate in this study
  • Subject has completed the week 52 evaluation either in Study 003 or 004

Exclusion criteria

  • Subject has had a serious infection, defined as requiring systemic treatment with antibiotics or antivirals (excluding oral administration)
  • Subject has been judged to be ineligible for participation in the study by the investigators/sub investigators

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

155 participants in 2 patient groups

KHK4827 140mg SC
Experimental group
Treatment:
Drug: KHK4827 140mg SC
KHK4827 210mg SC
Experimental group
Treatment:
Drug: KHK4827 210mg SC

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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