A Study to Evaluate the Efficacy and Safety of Subcutaneous MK-3222, Followed by an Optional Long-Term Safety Extension Study, in Participants With Moderate-to-Severe Chronic Plaque Psoriasis (MK-3222-010)

NCT01722331 | Completed Phase 3 Results DMC

• 4 other identifiers: 3222-0102012-002255-42P07770132284
• Study Type: interventional
• Target: 772
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is being conducted to evaluate the efficacy and safety/tolerability of subcutaneous tildrakizumab (MK-3222), followed by an optional long-term safety extension study, in participants with moderate-to-severe chronic plaque psoriasis.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (5)

• Percentage of Participants With Psoriasis Area Sensitivity Index 75 (PASI-75) Response at Week 12 (Base Study)

  The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the amount of body surface for each region involved (head=0.1; upper limbs=0.2; trunk= 0.3; and lower limbs=0.4) and the degree of involvement for each body region (0=no involvement to 6=90-100% involvement). Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline.

  Week 12 (or end of trial if prior to Week 12)

• Percentage of Participants With a Physician's Global Assessment (PGA) Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 12 (Base Study)

  The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5.

  Baseline and Week 12 (or end of trial if prior to Week 12)

• Number of Participants Experiencing an Adverse Event Up to Week 12 (Base Study)

  An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

  Up to 12 weeks

• Number of Participants Discontinuing Study Drug Due to an Adverse Event Up to Week 12 (Base Study)

  An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

  Up to 12 weeks

• Number of Participants Discontinuing Study Drug Due to a Drug-Related Adverse Event (Base Study)

  A drug-related adverse event is an adverse event that has been determined by the investigator to be related to the study drug.

  Up to 12 weeks

Secondary Outcomes (5)

• Percentage of Participants With PASI-90 Response At Week 12

  Week 12 (or end of trial if prior to Week 12)

• Percentage of Participants With PASI-100 Response at Week 12

  Week 12 (or end of trial if prior to Week 12)

• Baseline Dermatology Life Quality Index (DLQI) Score

  Baseline

• Change From Baseline in the Participant DLQI Score at Week 12

  Baseline and Week 12 (or end of trial if prior to Week 12)

• Percentage of Participants With DLQI Score of 0 or 1 at Week 12

  Week 12 (or end of trial if prior to Week 12)

Study Arms (3)

Tildrakizumab 200 mg

EXPERIMENTAL

Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.

Drug: Tildrakizumab 200 mg; Drug: Matching Placebo

Tildrakizumab 100 mg

EXPERIMENTAL

Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.

Drug: Tildrakizumab 100 mg; Drug: Matching Placebo

Placebo

PLACEBO COMPARATOR

Matching placebo administered SC once a week at Weeks 0 and 4.

Drug: Tildrakizumab 200 mg; Drug: Tildrakizumab 100 mg; Drug: Matching Placebo

Interventions

Tildrakizumab 200 mg DRUG

Two tildrakizumab 100 mg/mL pre-filled syringes (PFS)

Also known as: MK-3222, SCH 900222

Placebo; Tildrakizumab 200 mg

Tildrakizumab 100 mg DRUG

Tildrakizumab 100 mg/mL PFS

Also known as: MK-3222, SCH 900222

Placebo; Tildrakizumab 100 mg

Matching Placebo DRUG

Matching placebo to tildrakizumab PFS

Placebo; Tildrakizumab 100 mg; Tildrakizumab 200 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of moderate-to-severe plaque psoriasis for at least 6 months prior to study enrollment
• A candidate for phototherapy or systemic therapy
• For the extension study: must have completed Part 3 of the base study
• For the extension study: must have achieved at least a PASI-50 response by the end of Part 3 of the base study
• For the extension study: must have received active tildrakizumab (MK-3222) treatment within 12 weeks prior to the end of Part 3 of the base study
• Premenopausal female participants must agree to abstain from heterosexual activity or use a medically accepted method of contraception or use appropriate effective contraception as per local regulations or guidelines
• If enrolled at a Japanese site, participants with psoriatic arthritis using non-steroidal anti-inflammatory drugs (NSAIDs) must be on a stable dose for at least 4 weeks prior to the first dose of study drug and must not be expected to require an increase in dose over the course of the study

You may not qualify if:

• Has erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis
• Current or history of severe psoriatic arthritis and is well-controlled on current treatment
• Women of child-bearing potential who are pregnant, intend to become pregnant within 6 months of completing the trial, or who are breast feeding
• Expected to require topical treatment, phototherapy, or systemic treatment during the trial
• Presence of any infection
• History of recurrent infection requiring treatment with systemic antibiotics within 2 weeks of screening
• Previous use of tildrakizumab (MK-3222) or other IL-23/Th-17 pathway inhibitors including P40, p19, and IL-17 antagonists
• Evidence of active or untreated latent tuberculosis (TB)
• Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
• At Japanese sites, positive test for HBs antibody and hepatitis B virus (HBV) deoxyribonucleic acid (DNA)
• At Japanese sites, positive test for the Hepatitis B core (HBc) antibody and HBV DNA
• For the extension study: women of child-bearing potential who are pregnant, intend to become pregnant within 6 months of completing the trial, or who are breast feeding
• For the extension study: active or uncontrolled significant organ dysfunction or clinically significant laboratory abnormalities
• For the extension study: expected to require topical treatment, phototherapy, or systemic treatment during the extension study
• At Japanese sites, abnormal for Beta D Glucan and/or KL-6 test result(s) at the screening visit.

Sponsors & Collaborators

• Sun Pharmaceutical Industries Limited: lead

Related Publications (8)

• Reich K, Papp KA, Blauvelt A, Tyring SK, Sinclair R, Thaci D, Nograles K, Mehta A, Cichanowitz N, Li Q, Liu K, La Rosa C, Green S, Kimball AB. Tildrakizumab versus placebo or etanercept for chronic plaque psoriasis (reSURFACE 1 and reSURFACE 2): results from two randomised controlled, phase 3 trials. Lancet. 2017 Jul 15;390(10091):276-288. doi: 10.1016/S0140-6736(17)31279-5. Epub 2017 Jun 6.

  PMID: 28596043 RESULT

• Armstrong AW, Blauvelt A, Lebwohl M, Asahina A, Gogineni R, Griffiths CEM. Efficacy and safety of tildrakizumab in patients with early- vs. late-onset psoriasis. Br J Dermatol. 2025 Aug 18;193(3):442-450. doi: 10.1093/bjd/ljaf171.

  PMID: 40365708 DERIVED

• Thaci D, Gerdes S, Du Jardin KG, Perrot JL, Puig L. Efficacy of Tildrakizumab Across Different Body Weights in Moderate-to-Severe Psoriasis Over 5 Years: Pooled Analyses from the reSURFACE Pivotal Studies. Dermatol Ther (Heidelb). 2022 Oct;12(10):2325-2341. doi: 10.1007/s13555-022-00793-z. Epub 2022 Sep 13.

  PMID: 36098877 DERIVED

• Igarashi A, Nakagawa H, Morita A, Okubo Y, Sano S, Imafuku S, Tada Y, Honma M, Mendelsohn AM, Kawamura M, Ohtsuki M. Efficacy and safety of tildrakizumab in Japanese patients with moderate to severe plaque psoriasis: Results from a 64-week phase 3 study (reSURFACE 1). J Dermatol. 2021 Jun;48(6):853-863. doi: 10.1111/1346-8138.15789. Epub 2021 Feb 25.

  PMID: 33630387 DERIVED

• Kerbusch T, Li H, Wada R, Jauslin PM, Wenning L. Exposure-response characterisation of tildrakizumab in chronic plaque psoriasis: Pooled analysis of 3 randomised controlled trials. Br J Clin Pharmacol. 2020 Sep;86(9):1795-1806. doi: 10.1111/bcp.14280. Epub 2020 Mar 25.

  PMID: 32162721 DERIVED

• Elewski B, Menter A, Crowley J, Tyring S, Zhao Y, Lowry S, Rozzo S, Mendelsohn AM, Parno J, Gordon K. Sustained and continuously improved efficacy of tildrakizumab in patients with moderate-to-severe plaque psoriasis. J Dermatolog Treat. 2020 Dec;31(8):763-768. doi: 10.1080/09546634.2019.1640348. Epub 2019 Jul 22.

  PMID: 31268369 DERIVED

• Reich K, Warren RB, Iversen L, Puig L, Pau-Charles I, Igarashi A, Ohtsuki M, Falques M, Harmut M, Rozzo S, Lebwohl MG, Cantrell W, Blauvelt A, Thaci D. Long-term efficacy and safety of tildrakizumab for moderate-to-severe psoriasis: pooled analyses of two randomized phase III clinical trials (reSURFACE 1 and reSURFACE 2) through 148 weeks. Br J Dermatol. 2020 Mar;182(3):605-617. doi: 10.1111/bjd.18232. Epub 2019 Jul 18.

  PMID: 31218661 DERIVED

• Jauslin P, Kulkarni P, Li H, Vatakuti S, Hussain A, Wenning L, Kerbusch T. Population-Pharmacokinetic Modeling of Tildrakizumab (MK-3222), an Anti-Interleukin-23-p19 Monoclonal Antibody, in Healthy Volunteers and Subjects with Psoriasis. Clin Pharmacokinet. 2019 Aug;58(8):1059-1068. doi: 10.1007/s40262-019-00743-7.

  PMID: 30915660 DERIVED

MeSH Terms

Interventions

tildrakizumab

Results Point of Contact

• Title: Head-Clinical Development
• Organization: Sun Pharma Advanced Research Company Limited

clinical.trials@sparcmail.com

912266455645

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2012
• First Posted: November 6, 2012
• Study Start: December 6, 2012
• Primary Completion: October 28, 2015
• Study Completion: November 10, 2021
• Last Updated: March 23, 2022
• Results First Posted: June 13, 2018

Record last verified: 2022-02