A Phase 2b Study of Baricitinib in Participants With Moderate to Severe Psoriasis

Lilly

Status and phase: Completed; Phase 2

Conditions: Psoriasis; Skin Diseases; Skin Diseases, Papulosquamous

Treatments: Drug: Baricitinib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01490632

14455

I4V-MC-JADP (Other Identifier)

Details and patient eligibility

About

This is a dose-ranging study designed to investigate the efficacy and safety of Baricitinib in the treatment of participants with moderate to severe, chronic plaque psoriasis as assessed by the Psoriasis Area and Severity Index (PASI) score and routine safety assessments.

Enrollment: 271 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• You must have active chronic plaque psoriasis for at least 6 months prior to entry into the study
• You are a candidate for systemic therapy and/or phototherapy
• You must have active plaque psoriasis covering at least 12% body surface area
• You must have Psoriasis Area and Severity Index (PASI) score of at least 12
• You must have Static Physician's Global Assessment (sPGA) score of at least 3

Exclusion criteria

• You must not have received a biologic agent/monoclonal antibody within 8 weeks prior to entry into the study

• You must not have prior treatment with an oral Janus kinase (JAK) inhibitor

• You must not have received a systemic psoriasis (Ps) therapy within 4 weeks prior to entry into the study

• You must not have received a phototherapy within 4 weeks prior to entry into the study

• You must not have received a topical Ps therapy with psoralens within 4 weeks prior to entry into the study

• You must not be pregnant or nursing

• If female of childbearing potential or a male, and do not agree to use 2 forms of highly effective methods of birth control for at least 28 days following the last dose of investigational product

• You must not have had symptomatic herpes zoster or herpes simplex infection within 12 weeks or have a history of disseminated/complicated herpes zoster

• You must not have evidence of active infection, such as fever ≥38.0ºC (100.4ºF)

• You must not have a history of active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)

• You must not be immunocompromised and, in the opinion of the investigator, are at an unacceptable risk for participating in the study

• You must not have known history hypogammaglobulinemia

• You must not have had a serious systemic or local infection within 12 weeks prior to entry into the study

• You must not have been exposed to a live vaccine within 12 weeks prior to entry into the study, or expected to need/receive a live vaccine (including herpes zoster vaccination) during the course of the study

• You must not have had household contact with a person with active tuberculosis (TB) and did not receive appropriate and documented prophylaxis for TB

• You must not have a serious and/or unstable illness that, in the opinion of the investigator, poses an unacceptable risk for the your participation in the study

• You must not have or have had a history of lymphoproliferative disease; or signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or active primary or recurrent malignant disease; or been in remission from clinically significant malignancy for less than 5 years

• You must not have a history of chronic alcohol abuse or intravenous (IV) drug abuse within the last 2 years

• You must not have donated blood of more than 500 mL within 4 weeks

• You must not have received a topical Ps treatment within 2 weeks prior to entry into the study

  • Exceptions:
  • class 6 (mild, such as desonide) or class 7 (least potent, such as hydrocortisone) topical steroids used on the face, axilla, palms, soles, and/or genitalia
  • non-medicated shampoos (for example, that do not contain corticosteroids, coal tar, or vitamin D3 analogues)
  • emollients that do not contain alpha or beta hydroxyl acids

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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271 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Part A: Placebo administered orally (PO) once daily (QD) for 12 weeks. Part B: Placebo participants stayed on placebo or re-randomized to baricitinib 8 milligram (mg) or 10 mg PO QD for 12 weeks. Part C: Baricitinib participants re-randomized to 4 mg or placebo PO QD for 16 weeks. Part D: Retreated with Part B efficacious dose.

Treatment:

Drug: Placebo

Baricitinib 2 mg

Experimental group

Description:

Part A: Baricitinib administered PO QD for initial 12 weeks. Part B: Depending on participant's response, participant was maintained on current dose, or re-randomized to increased dose PO QD for 12 weeks. Part C: Participants re-randomized to half dose or placebo PO QD for 16 weeks. Part D: Participants retreated with Part B efficacious dose for 52 weeks.

Treatment:

Drug: Baricitinib

Baricitinib 4 mg

Experimental group

Description:

Part A: Baricitinib administered PO QD for initial 12 weeks. Part B: Depending on participant's response, participant was maintained on current dose, or re-randomized to increased dose PO QD for 12 weeks. Part C: Participants re-randomized to half dose or placebo PO QD for 16 weeks. Part D: Participants retreated with Part B efficacious dose for 52 weeks.

Treatment:

Drug: Baricitinib

Baricitinib 8 mg

Experimental group

Description:

Part A: Baricitinib administered PO QD for initial 12 weeks. Part B: Depending on participant's response, participant was maintained on current dose, or re-randomized to increased dose PO QD for 12 weeks. Part C: Participants re-randomized to half dose or placebo PO QD for 16 weeks. Part D: Participants retreated with Part B efficacious dose for 52 weeks.

Treatment:

Drug: Baricitinib

Baricitinib 10 mg

Experimental group

Description:

Part A: Baricitinib administered PO QD for initial 12 weeks. Part B: Depending on participant's response, participant was maintained on current dose, or discontinued from the study for 12 weeks. Part C: Participants re-randomized to 4mg dose or placebo PO QD for 16 weeks. Part D: Participants retreated with Part B efficacious dose for 52 weeks.

Treatment:

Drug: Baricitinib