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KPL-301 for Subjects With Giant Cell Arteritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03827018
Recruitment Status : Completed
First Posted : February 1, 2019
Last Update Posted : September 1, 2021
Sponsor:
Information provided by (Responsible Party):
Kiniksa Pharmaceuticals, Ltd.

Brief Summary:
The primary objective of the study is to evaluate the efficacy of mavrilimumab (KPL-301) versus placebo, co-administered with a 26-week corticosteroid taper, for maintaining sustained remission for 26 weeks in subjects with new onset or relapsing/refractory giant cell arteritis (GCA).

Condition or disease Intervention/treatment Phase
Giant Cell Arteritis Combination Product: mavrilimumab Combination Product: placebo Drug: prednisone Phase 2

Detailed Description:
This Phase 2 randomized, double-blind, placebo-controlled proof of concept study will evaluate the efficacy and safety of mavrilimumab co-administered with a 26-week corticosteroid taper in subjects with GCA. The study will consist of a screening period (up to 6 weeks), a 26-week double-blind placebo-controlled period during which subjects will receive blinded mavrilimumab or placebo co-administered with a 26-week corticosteroid taper, and a 12-week washout safety follow-up period during which subjects will discontinue and wash off blinded mavrilimumab or placebo.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Upon successful completion of the screening procedures, diagnosis criteria will be entered into an interactive web response system, and eligible subjects will be stratified for randomized study treatment into two cohorts according to whether subjects have new-onset or relapsing/refractory disease.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-blind Placebo-controlled Study to Test the Efficacy and Safety of KPL-301 in Giant Cell Arteritis
Actual Study Start Date : September 20, 2018
Actual Primary Completion Date : August 13, 2020
Actual Study Completion Date : November 25, 2020


Arm Intervention/treatment
Active Comparator: mavrilimumab
Subjects randomized to mavrilimumab will receive 150 mg every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.
Combination Product: mavrilimumab
1 mL of 150 mg in a pre-filled syringe
Other Name: KPL-301

Drug: prednisone
Prednisone tablets for oral administration containing either 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone United States Pharmacopeia (USP)

Placebo Comparator: placebo
Subjects randomized to placebo will receive placebo every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.
Combination Product: placebo
1 mL of placebo in a pre-filled syringe

Drug: prednisone
Prednisone tablets for oral administration containing either 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone United States Pharmacopeia (USP)




Primary Outcome Measures :
  1. Time to flare by Week 26, defined as time from randomization to the date of first flare occurring within the 26-week period, in the modified intent-to-treat population. [ Time Frame: week 26 ]

Secondary Outcome Measures :
  1. Time to flare by Week 26 in the per-protocol population. [ Time Frame: week 26 ]
  2. Percentage of subjects who have completed the 26-week corticosteroid taper and who have a normal erythrocyte sedimentation rate. [ Time Frame: week 26 ]
  3. Percentage of subjects who have completed the 26-week corticosteroid taper and who have a normal c-reactive protein level. [ Time Frame: week 26 ]
  4. Percentage of subjects who have completed the 26-week corticosteroid taper and who have no signs or symptoms of GCA. [ Time Frame: week 26 ]
  5. Time to corticosteroid dose of zero mg/day. [ Time Frame: through study completion up to 26 weeks ]
  6. Cumulative steroid dose at week 26 and at the end of the washout safety follow-up period. [ Time Frame: through study completion up to 26 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Selected Inclusion Criteria:

  1. Subjects with new-onset or relapsing/refractory GCA.
  2. Westergren erythrocyte sedimentation rate > 30 mm/hour or c-reactive protein ≥ 1 mg/ dL.
  3. Remission of GCA at or before Day 0.
  4. Female subjects must be postmenopausal or permanently sterile following documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or tubal ligation or having a male partner with vasectomy as affirmed by the subject, or nonpregnant, nonlactating, and if sexually active having agreed to use a highly effective method of contraception.
  5. Male subjects must have documented vasectomy or if sexually active must agree to use a highly effective method of contraception with their partners of childbearing potential.

Selected Exclusion Criteria:

  1. Transplanted organs (except corneal transplant performed more than 3 months prior to randomization).
  2. Concurrent enrollment in another interventional clinical study.
  3. Treatment with non-biologic investigational drug therapy within 4 weeks or 5 half-lives of the study agent, whichever was longer, prior to screening.
  4. Cell-depleting biological therapies within 12 months prior to Day 0, or noncell-depleting biological therapies within 8 weeks (or 5 half-lives, whichever is longer) prior to screening.
  5. Treatment with alkylating agents within 12 weeks prior to screening.
  6. Intramuscular, Intra-articular or IV corticosteroids within 4 weeks prior to screening.
  7. Receipt of live (attenuated) vaccine within the 4 weeks before Day 0.
  8. Treatment with hydroxychloroquine, cyclosporine A, azathioprine, cyclophosphamide, or mycophenolate mofetil (MMF) within 4 weeks of screening.
  9. Female subjects who are pregnant, intending to become pregnant, or are breastfeeding.
  10. Known history of allergy or reaction to any component of the mavrilimumab or placebo formulation or to any other biologic therapy or prednisone or any of its excipients.
  11. Positive (or 2 indeterminate) QuantiFERON test results.
  12. Clinically significant active infection or infection requiring hospitalization or IV antibiotics within 12 weeks before screening or opportunistic infection within 6 months before screening.
  13. Chronic active hepatitis B infection.
  14. Subjects at a high risk of infection, a history of an infected joint prosthesis still in situ, leg ulcers, indwelling urinary catheter, or persistent or recurrent chest infections.
  15. History of cancer within the last 10 years, except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated and considered cured.
  16. Evidence of clinically-uncontrolled respiratory disease.
  17. History of chronic respiratory tract infections.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827018


Locations
Show Show 47 study locations
Sponsors and Collaborators
Kiniksa Pharmaceuticals, Ltd.
Investigators
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Study Director: John Paolini, M.D. Kiniksa Pharmaceuticals, Ltd.
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Responsible Party: Kiniksa Pharmaceuticals, Ltd.
ClinicalTrials.gov Identifier: NCT03827018    
Other Study ID Numbers: KPL-301-C001
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Kiniksa Pharmaceuticals, Ltd.:
GCA
temporal arteritis
Horton's disease
Additional relevant MeSH terms:
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Polymyalgia Rheumatica
Giant Cell Arteritis
Arteritis
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Prednisone
Mavrilimumab
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antirheumatic Agents