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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02959944
Other study ID # PCYC-1140-IM
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date May 11, 2017
Est. completion date July 12, 2021

Study information

Verified date March 2023
Source Pharmacyclics LLC.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects with newly diagnosed moderate to severe cGVHD.


Recruitment information / eligibility

Status Completed
Enrollment 193
Est. completion date July 12, 2021
Est. primary completion date March 27, 2020
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Key Inclusion Criteria: - New onset moderate or severe cGVHD as defined by the 2014 National Institutes of Health (NIH) Consensus Development Project Criteria - Need for systemic treatment with corticosteroids for cGVHD - No previous systemic treatment for cGVHD (including extracorporeal photopheresis [ECP]) - Participants may be receiving other immunosuppressants for the prophylaxis or treatment of acute GVHD but if the subject is receiving prednisone for prophylaxis or treatment of acute GVHD it must be at or below 0.5 mg/kg/d - Age =12 years old - Karnofsky or Lansky (subjects <16 years) performance status =60 Key Exclusion Criteria: - Received any previous systemic treatment for cGVHD with the exception of corticosteroids administered for cGVHD within the 72 hours prior to signing the informed consent form. - Inability to begin a prednisone dose =0.5 mg/kg/d for the treatment of cGVHD - Any uncontrolled infection or active infection requiring ongoing systemic treatment - Progressive underlying malignant disease or any post-transplant lymphoproliferative disease - Known bleeding disorders - Active hepatitis C virus (HCV) or hepatitis B virus (HBV)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ibrutinib
Ibrutinib capsules administered orally daily
Placebo
Placebo capsules administered orally daily
Prednisone
Prednisone administered daily

Locations

Country Name City State
Australia The Kinghorn Cancer Centre /ID# 1140-1165 Darlinghurst New South Wales
Australia Royal Brisbane and Women's Hospital /ID# 1140-0190 Herston Queensland
Australia Royal Children's Hospital/ID# 1140-1154 Parkville Victoria
Australia Royal Melbourne Hospital (RMH) /ID# 1140-0633 Parkville Victoria
Australia Fiona Stanley Hospital /ID# 1140-0880 Perth Western Australia
Australia Westmead Hospital /ID# 1140-0848 Westmead New South Wales
Austria Univ. Klinik for Innere Medizin, Klinische Abteilung for Hematologie, Graz /ID# 1140-0373 Graz
Austria Krankenhaus der Elisabethinen Linz /ID# 1140-0849 Linz
Canada CHU Sainte-Justine /ID# 1140-1143 Montreal Quebec
Canada The Ottawa Hospital Regional Cancer Center /ID# 1140-0159 Ottawa Ontario
Canada Princess Margaret Cancer Centre /ID# 1140-0043 Toronto Ontario
Canada University of British Columbia (UBC) - Vancouver General Hospital (VGH) /ID# 1140-1166 Vancouver British Columbia
China Chinese PLA General Hospital /ID# 1140-1198 Beijing
China Nanfang Hospital /ID# 1140-1379 Guangzhou Shi
China The First Affiliated Hospital of Soochow University /ID# 1140-1208 Suzhou Jiangsu
Croatia UHC Zagreb /ID# 1140-1169 Zagreb
France CHU Amiens Groupe hospitalier Sud /ID# 1140-1205 Amiens
France CHU de GRENOBLE Alpes /ID# 1140-1058 Grenoble
France Centre Hospitalier Regional Universitaire de Lille /ID# 1140-0750 Lille
France CHU de Nantes /ID# 1140-0520 Nantes
France Groupe Hospitalier Pitie-Salpetriere /ID# 1140-0918 Paris
France Hopital Saint-Louis - Institut Hematologie Centre Hayem CHU /ID# 1140-0735 Paris Ile-de-France
France Hopital de Brabois /ID# 1140-0775 Vandoeuvre-lès-nancy Meurthe-et-Moselle
Germany Universitaetsklinikum Dresden /ID# 1140-1367 Dresden
Germany Hannover Medical School /ID# 1140-1141 Hannover
Germany Dr. Haunerschen Kinderspital /ID# 1140-1142 Munich
Germany Universitatsklinikum Munster /ID# 1140-1195 Munster Niedersachsen
Germany University Hospital of Regensburg /ID# 1140-1446 Regensburg
Germany Robert Bosch Hospital /ID# 1140-1160 Stuttgart Baden-Wuerttemberg
Hungary St. Laszlo Hospital /ID# 1140-1164 Budapest
Italy A.O. Univ. Ospedali Riuniti /ID# 1140-0932 Ancona Marche
Italy ASST Papa Giovanni XXIII /ID# 1140-1231 Bergamo
Italy Ospedale San Raffaele IRCCS /ID# 1140-0523 Milan
Italy IRCCS Ospedale Pediatrico Bambino Gesu /ID# 1140-1150 Rome Lazio
Italy University of Torino /ID# 1140-1268 Torino
Italy Centro Trapianti Cellule Staminali, Ospedale Infantile Regina Margherita /ID# 1140-1156 Turin
Japan Anjou Kousei Hospital /ID# 1140-1435 Anjo Aichi
Japan Dup_Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 1140-1439 Bunkyo-ku Tokyo
Japan Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital /ID# 1140-1437 Hiroshima-shi Hiroshima
Japan Tokai University Hospital /ID# 1140-1444 Isehara-shi Kanagawa
Japan Osaka Women's and Children's Hospital /ID# 1140-1440 Izumi-Shi Osaka
Japan Kobe City Medical Center General Hospital /ID# 1140-1438 Kobe-shi Hyogo
Japan Kumamoto Medical Center /ID# 1140-1431 Kumamoto
Japan Duplicate_Kurashiki Central Hospital /ID# 1140-1442 Kurishiki-shi Okayama
Japan Hyogo College of Medicine College Hospital /Id# 1140-1434 Nishinomiya-shi Hyogo
Japan Okayama University Hospital /ID# 1140-1430 Okayama-shi Okayama
Japan Osaka City University Hospital /ID# 1140-1157 Osaka-shi Osaka
Japan Hokkaido University Hospital /ID# 1140-1436 Sapporo
Japan National Center for Child Health and Development /ID# 1140-1443 Setagaya-ku Tokyo
Japan Duplicate_University of Tsukuba Hospital /ID# 1140-1445 Tsukuba-shi Ibaraki
Korea, Republic of Kyungpook National Univ Hosp /ID# 1140-1153 Daegu Daegu Gwang Yeogsi
Korea, Republic of Yonsei University Health System, Severance Hospital /ID# 1140-0927 Seodaemun-gu Seoul Teugbyeolsi
Korea, Republic of Asan Medical Center /ID# 1140-0963 Seoul
Korea, Republic of Cath Univ Seoul St Mary's Hosp /ID# 1140-0928 Seoul Seoul Teugbyeolsi
Korea, Republic of Samsung Medical Center /ID# 1140-0925 Seoul Seoul Teugbyeolsi
Korea, Republic of SoonChunHyang University Seoul /ID# 1140-1163 Seoul
Singapore National University Cancer Institute - National University Health System /ID# 1140-1155 Singapore
Singapore Singapore General Hospital /ID# 1140-1162 Singapore
Spain Hospital Clinic /ID# 1140-0533 Barcelona
Spain Hospital Santa Creu i Sant Pau /ID# 1140-0535 Barcelona
Spain Hospital Universitario Virgen del Rocio /ID# 1140-0863 Sevilla
Spain Hospital Clinico Universitario de Valencia /ID# 1140-1145 Valencia
Taiwan China Medical University Hosp /ID# 1140-1199 Taichung City Taichung
Taiwan National Taiwan Univ Hosp /ID# 1140-1184 Taipei City Taipei
United States Emory University, Winship Cancer Institute /ID# 1140-0033 Atlanta Georgia
United States Emory University/Winship Cancer Institute /ID# 1140-1179 Atlanta Georgia
United States UCHSC Anschultz Cancer Pavilion /ID# 1140-0068 Aurora Colorado
United States University of Maryland /ID# 1140-0205 Baltimore Maryland
United States Boston Childrens Hospital /ID# 1140-1615 Boston Massachusetts
United States Dana-Farber Cancer Institute /ID# 1140-0349 Boston Massachusetts
United States Massachusetts General Hospital Cancer Center /ID# 1140-0020 Boston Massachusetts
United States Montefiore Medical Center - Moses Campus /ID# 1140-0120 Bronx New York
United States University of North Carolina - Lineberger Comprehensive Cancer Center /ID# 1140-1133 Chapel Hill North Carolina
United States Medical University of South Carolina, MUSC /ID# 1140-0738 Charleston South Carolina
United States University of Chicago /ID# 1140-0126 Chicago Illinois
United States Univ Hosp Cleveland /ID# 1140-0941 Cleveland Ohio
United States Barbara Ann Karmanos Cancer In /ID# 1140-0130 Detroit Michigan
United States Hackensack University Medical Center/ John Theurer Cancer Center /ID# 1140-0343 Hackensack New Jersey
United States Indiana University Melvin and Bren Simon Cancer Center /ID# 1140-0010 Indianapolis Indiana
United States University of Kentucky /ID# 1140-1140 Lexington Kentucky
United States University of Louisville Hospital /ID# 1140-1131 Louisville Kentucky
United States Loyola University /ID# 1140-0713 Maywood Illinois
United States Jackson Memorial Hospital, University of Miami /ID# 1140-0647 Miami Florida
United States University of Minnesota /ID# 1140-0807 Minneapolis Minnesota
United States West Virginia University /ID# 1140-1090 Morgantown West Virginia
United States Vanderbilt University Medical Center Vanderbilt Ingram Cancer Center /ID# 1140-0024 Nashville Tennessee
United States Rutgers Cancer Institute of NJ /ID# 1140-0803 New Brunswick New Jersey
United States Columbia University Medical Center, MS-CHONY /ID# 1140-1124 New York New York
United States New York Presbyterian Hospital/Weill Cornell Med College /ID# 1140-0200 New York New York
United States Stony Brook University Medical Center /ID# 1140-0719 New York New York
United States Weill Cornell Physicians - Hematologic Malignancies & Bone Marrow Transplant /ID# 1140-0019 New York New York
United States Florida Hospital Cancer Institute/Adventist Health System/Sunbelt, Inc /ID# 1140-1121 Orlando Florida
United States LPCH Stanford /ID# 1140-1128 Palo Alto California
United States University of Pittsburgh - UPMC (Hillman Cancer Center) /ID# 1140-0050 Pittsburgh Pennsylvania
United States Mayo Clinic, Rochester, MN /ID# 1140-0240 Rochester Minnesota
United States University of Rochester Cancer Center /ID# 1140-0127 Rochester New York
United States Methodist San Antonio /ID# 1140-1118 San Antonio Texas
United States Ucsf /Id# 1140-0003 San Francisco California
United States Arizona Oncology - Scottsdale - Cancer Transplant Institute Location /ID# 1140-1120 Scottsdale Arizona
United States Fred Hutchinson Cancer Research Center /ID# 1140-0404 Seattle Washington
United States Stanford University/Stanford Cancer Center, Pasteur Drive /ID# 1140-0400 Stanford California
United States Children's National Medical Center /ID# 1140-1122 Washington District of Columbia

Sponsors (2)

Lead Sponsor Collaborator
Pharmacyclics LLC. Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  China,  Croatia,  France,  Germany,  Hungary,  Italy,  Japan,  Korea, Republic of,  Singapore,  Spain,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary Analysis: Response Rate at 48 Weeks Response rate was defined as the percentage of participants who were responders. Responders were defined as participants who had a complete response (CR) or a partial response (PR) at 48 weeks without starting any subsequent therapy for cGVHD or having evidence of relapse of their underlying disease that was indication for transplant prior to response assessment at 48 weeks.
Response was defined using the National Institutes of Health (NIH) Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR is defined as resolution of all manifestations in each organ or site. PR is defined as improvement in at least 1 organ or site without progression in any other organ or site.
48 weeks (Cumulatively up to 30 March 2020)
Primary Final Analysis: Response Rate at 48 Weeks Response rate was defined as the percentage of participants who were responders. Responders were defined as participants who had a complete response (CR) or a partial response (PR) at 48 weeks without starting any subsequent therapy for cGVHD or having evidence of relapse of their underlying disease that was indication for transplant prior to response assessment at 48 weeks.
Response was defined using the National Institutes of Health (NIH) Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR is defined as resolution of all manifestations in each organ or site. PR is defined as improvement in at least 1 organ or site without progression in any other organ or site.
48 weeks (Cumulatively up to 12 July 2021)
Secondary Primary Analysis: Cumulative Incidence of Withdrawal of All Corticosteroids for Treatment of cGVHD The cumulative incidence of withdrawal of all corticosteroids (95% confidence interval [CI]) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy. Data presented are the estimated proportion of participants withdrawing all corticosteroids at given time point. The time to withdrawal of corticosteroids is computed from randomization date to the first date of withdrawal of all corticosteroids for treatment of cGVHD to 0 mg daily for at least 30 days. Months 3, 6, 9, 12, 15, 18, 21, 24 (Cumulatively up to 30 March 2020)
Secondary Final Analysis: Cumulative Incidence of Withdrawal of All Corticosteroids for Treatment of cGVHD The cumulative incidence of withdrawal of all corticosteroids (95% confidence interval [CI]) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy. Data presented are the estimated proportion of participants withdrawing all corticosteroids at given time point. The time to withdrawal of corticosteroids is computed from randomization date to the first date of withdrawal of all corticosteroids for treatment of cGVHD to 0 mg daily for at least 30 days. Months 3, 6, 9, 12, 15, 18, 21, 24 (Cumulatively up to 12 July 2021)
Secondary Primary Analysis: Cumulative Incidence of Withdrawal of All Immunosuppressants The cumulative incidence of withdrawal of all immunosuppressants (95% CI) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy. Data presented are the estimated proportion of participants withdrawing all immunosuppressants at a given time point. The time to withdrawal of all immunosuppressants is computed from randomization date to the first date of withdrawal of all immunosuppressants for treatment of cGVHD, sustained for at least 30 days. All immunosuppressants include corticosteroids but they do not include ibrutinib. Months 3, 6, 9, 12, 15, 18, 21, 24 (cumulatively up to 30 March 2020)
Secondary Final Analysis: Cumulative Incidence of Withdrawal of All Immunosuppressants The cumulative incidence of withdrawal of all immunosuppressants (95% CI) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy. Data presented are the estimated proportion of participants withdrawing all immunosuppressants at a given time point. The time to withdrawal of all immunosuppressants is computed from randomization date to the first date of withdrawal of all immunosuppressants for treatment of cGVHD, sustained for at least 30 days. All immunosuppressants include corticosteroids but they do not include ibrutinib. Months 3, 6, 9, 12, 15, 18, 21, 24 (Cumulatively up to 12 July 2021)
Secondary Primary Analysis: Response Rate at 24 Weeks Response rate was defined as the percentage of participants who were responders. Responders were defined as participants who had a CR or PR at 24 weeks without starting any subsequent therapy for cGVHD or having evidence of relapse of their underlying disease that was indication for transplant prior to response assessment at 24 weeks.
Response was defined using the National Institutes of Health (NIH) Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR is defined as resolution of all manifestations in each organ or site. PR is defined as improvement in at least 1 organ or site without progression in any other organ or site.
24 weeks (Cumulatively up to 30 March 2020)
Secondary Final Analysis: Response Rate at 24 Weeks Response rate was defined as the percentage of participants who were responders. Responders were defined as participants who had a CR or PR at 24 weeks without starting any subsequent therapy for cGVHD or having evidence of relapse of their underlying disease that was indication for transplant prior to response assessment at 24 weeks.
Response was defined using the National Institutes of Health (NIH) Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR is defined as resolution of all manifestations in each organ or site. PR is defined as improvement in at least 1 organ or site without progression in any other organ or site.
24 weeks (Cumulatively up to 12 July 2021)
Secondary Primary Analysis: Percentage of Participants With Improvement in Overall Score on Lee cGVHD Symptom Scale at Two Consecutive Visits Clinically meaningful improvement on Lee cGVHD symptom scale was defined as at least a 7-point decrease in Lee Symptom Scale overall summary score on at least 2 consecutive visits, not preceded by progressive disease, relapse of underlying disease or start of subsequent cGVHD treatment.
The Lee cGVHD Symptom Scale score has 7 subscales (Skin, Eyes and Mouth, Breathing, Eating and Digestion, Muscles and Joints, Energy, and Mental and Emotional) with ratings as follows: 0- Not at all, 1- Slightly, 2 Moderately, 3 Quite a bit, 4-Extremely, with lower values representing a better outcome. A score is calculated for each subscale by taking the mean of all items completed if more than 50% were answered and normalizing to a 0 to 100 scale. An overall score is calculated as the average of these 7 subscales if at least 4 subscales have valid scores.
Assessed at Weeks 5, 13, 25, 37, 49, 30 days after the last dose of study drug, and then every 12 weeks of follow-up until progressed disease. (Cumulatively up to 30 March 2020)
Secondary Final Analysis: Percentage of Participants With Improvement in Overall Score on Lee cGVHD Symptom Scale at Two Consecutive Visits Clinically meaningful improvement on Lee cGVHD symptom scale was defined as at least a 7-point decrease in Lee Symptom Scale overall summary score on at least 2 consecutive visits, not preceded by progressive disease, relapse of underlying disease or start of subsequent cGVHD treatment.
The Lee cGVHD Symptom Scale score has 7 subscales (Skin, Eyes and Mouth, Breathing, Eating and Digestion, Muscles and Joints, Energy, and Mental and Emotional) with ratings as follows: 0- Not at all, 1- Slightly, 2 Moderately, 3 Quite a bit, 4-Extremely, with lower values representing a better outcome. A score is calculated for each subscale by taking the mean of all items completed if more than 50% were answered and normalizing to a 0 to 100 scale. An overall score is calculated as the average of these 7 subscales if at least 4 subscales have valid scores.
Assessed at Weeks 5, 13, 25, 37, 49, 30 days after the last dose of study drug, and then every 12 weeks of follow-up until progressed disease. (Cumulatively up to 12 July 2021)
Secondary Primary Analysis: Percentage of Participants Who Achieved Reduction of Prednisone Dose Level to Less Than 0.15 mg/kg/Day at 24 Weeks Sustained for at Least 30 Days 24 weeks (Cumulatively up to 30 March 2020)
Secondary Final Analysis: Percentage of Participants Who Achieved Reduction of Prednisone Dose Level to Less Than 0.15 mg/kg/Day at 24 Weeks Sustained for at Least 30 Days 24 weeks (Cumulatively up to 12 July 2021)
Secondary Primary Analysis: Overall Survival (OS) OS was defined as the time of randomization until the time of death due to any cause, in months. Median time on study (cumulatively up to 30 March 2020) was 19.8 months and 18.4 months for the Ibrutinib + Prednisone and Placebo + Prednisone arms, respectively.
Secondary Final Analysis: OS OS was defined as the time of randomization until the time of death due to any cause, in months. Median time on study (cumulatively up to 12 July 2021) was 33.1 months and 32.5 months for the Ibrutinib + Prednisone and Placebo + Prednisone arms, respectively.
Secondary Primary Analysis: Duration of Response (DOR) for Participants Who Had PR or CR at Any Time Response was defined using the NIH Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower GI, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR was defined as resolution of all manifestations in each organ or site. PR was defined as improvement in at least 1 organ or site without progression in any other organ or site. Duration of response was estimated by Kaplan-Meier methodology. Response was assessed every 4 weeks from Week 5 through Week 25, Week 37, Week 49, 30 days after the last dose of study drug, and then every 12 weeks of follow-up until progressed disease. (Cumulatively up to 30 March 2020)
Secondary Final Analysis: DOR for Participants Who Had PR or CR at Any Time Response was defined using the NIH Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower GI, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR was defined as resolution of all manifestations in each organ or site. PR was defined as improvement in at least 1 organ or site without progression in any other organ or site. Duration of response was estimated by Kaplan-Meier methodology. Response was assessed every 4 weeks from Week 5 through Week 25, Week 37, Week 49, 30 days after the last dose of study drug, and then every 12 weeks of follow-up until progressed disease. (Cumulatively up to 12 July 2021)
Secondary Primary Analysis: Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs Placebo in Combination With Prednisone AE: any untoward medical occurrence, which does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; is life-threatening; requires in-patient hospitalization >24 hours or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event. Severity was graded according to the Common Terminology Criteria for Adverse Events version 4.03 (grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening, grade 5=death). Treatment-related events are those that were possibly related or related to study treatment per investigator's judgment. Treatment emergent AEs (TEAEs) occurred from the first dose of study drug up to 30 days after the last dose of study drug. From first dose of study drug through the end of treatment plus 30 days. As of data cutoff (cumulatively up to 30 March 2020), median ibrutinib treatment duration was 5.4 months and the median placebo treatment duration was 6.4 months.
Secondary Final Analysis: Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs Placebo in Combination With Prednisone AE: any untoward medical occurrence, which does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; is life-threatening; requires in-patient hospitalization >24 hours or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event. Severity was graded according to the Common Terminology Criteria for Adverse Events version 4.03 (grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening, grade 5=death). Treatment-related events are those that were possibly related or related to study treatment per investigator's judgment. Treatment emergent AEs (TEAEs) occurred from the first dose of study drug up to 30 days after the last dose of study drug. From first dose of study drug through the end of treatment plus 30 days. As of data cutoff (cumulatively up to 12 July 2021), median ibrutinib treatment duration was 5.4 months and the median placebo treatment duration was 6.4 months.
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