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TerminatedNCT02596893Updated Aug 28, 2019Results posted

Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease

A Phase 3 interventional study of GED-0301 and Placebo in Crohn Disease, sponsored by Celgene. Terminated at 538 sites in 35 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-28.

Sponsored by Celgene · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
701
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of study is to test the effects of an experimental medication GED-0301 (mongersen) in patients who have active Crohn's disease. The study will test GED-0301 compared to placebo for 52 weeks. The study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned. Patients in this study will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment of Crohn's disease.

After 12 weeks in the study until the end of the study, patients who do not have an improvement in their Crohns disease symptoms will have the option to enter a long term active treatment study. Participants who discontinued the study anytime or completed the study at Week 52 were then observed for an additional 4 weeks.

02

Conditions studied

  • Crohn Disease

Browse trials for

Keywords

  • Crohn's Disease
  • GED-0301
  • Mongersen
  • IBD
  • Safety
  • Efficacy
03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 701 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Celgene is the lead sponsor of 419 studies on the registry; 13 are open to participants now.

Of its 100 completed or terminated interventional studies of FDA-regulated products, 29 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Subjects must satisfy the following criteria to be enrolled in the study:

  • Male or female ≥ 18 years
  • Active Crohn's disease (CD) disease as determined by the Crohn's Disease Activity Index (CDAI) score and the Simple Endoscopic Score for Crohn's Disease (SES-CD)
  • Must meet a determined average minimum number of daily stools or rating of abdominal pain over a 7 day period
  • Subject must have failed or experienced intolerance to at least one of the following: budesonide; systemic corticosteroids; immunosuppressants (eg, azathiopurine, 6-mercaptopurine, or methotrexate); or biologics for the treatment of CD.

Exclusion criteria

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

  • Diagnosis of ulcerative colitis (UC), indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis
  • Local manifestations of Crohn's Disease (CD) such as symptomatic/severe strictures, abscesses, short bowel syndrome; or other disease complications for which surgery might be indicated or could confound the evaluation of efficacy
  • Intestinal resection within 6 months or any intra-abdominal surgery within 3 months prior to the Screening Visit
  • Ileostomy or a colostomy
  • Subject has a history of any clinically significant medical condition that, in the investigator's opinion, would prevent the subject from participating in the study.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
701 participants (actual)

Study arms

  • Experimental
    GED0301 160mg x 12 weeks followed by periodic 160 mg GED0301

    GED-0301 160 mg once daily (QD) for 12 weeks; followed by placebo QD for 4 weeks; followed by alternating GED-0301 160 mg QD for 4 weeks and placebo QD for 4 weeks, until the the Week 52 Visit

    Drug: GED-0301 · Drug: Placebo

  • Experimental
    GED0301 160mg x 12 weeks followed by periodic GED0301 40mg

    GED-0301 160 mg once daily (QD) for 12 weeks; followed by placebo QD for 4 weeks; followed by alternating GED-0301 40 mg QD for 4 weeks and placebo QD for 4 weeks, until the Week 52 Visit

    Drug: GED-0301 · Drug: Placebo

  • Experimental
    GED0301 160mg x 12 weeks followed by continuous GED0301 40mg

    GED-0301 160 mg once daily (QD) for 12 weeks; followed by continuous GED-0301 40 mg QD, until the Week 52 Visit

    Drug: GED-0301

  • Placebo comparator
    Placebo

    Placebo once daily (QD) until the Week 52 Visit

    Drug: Placebo

Interventions

  • DrugGED-0301
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. The Percentage of Participants Who Achieved a Clinical Remission at Week 12

    Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score \< 150. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the affect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined \>450.

    Time frame: Week 12

Secondary outcomes

  1. Percentage of Participants Who Achieved Clinical Remission at Week 52

    Clinical remission is defined as a CDAI score \< 150 and is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined \>450.

    Time frame: Week 52

  2. Percentage of Participants With Endoscopic Response-50 Centrally Read at Week 52

    An endoscopic response-50 is defined as a reduction of at least 50% compared with baseline in simple endoscopic score for Crohn's Disease (SES-CD). The SES-CD assesses the size of mucosal ulcers, the extent of ulcerated surface, the extent of affected surface, and the presence and type of narrowings. Scores range from 0 to 60 with higher scores reflecting more severe disease. The SES-CD calculations include: * Ulcers scored as: 0: no 1. aphthous (0.1-0.5 cm) 2. large (0.5-2 cm) 3. very large (\>2 cm) * Surface involved disease 0: 0% 1. \<50% 2. 50-75% 3. \>75% Surface involved by ulcerations: 0: 0% 1. \<10% 2. 10-30% 3. \>30% - Narrowings: 0: No 1. Single, can be passed 2. Multiple, can be passed 3. Cannot be passed Grand Total = SES-CD score

    Time frame: Week 52

  3. The Percentage of Participants Who Achieved a Clinical Response at Week 12

    A clinical response is defined as a CDAI score decrease from baseline ≥ 100 points. The CDAI is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined \>450.

    Time frame: Week 12

  4. The Percentage of Participants Who Achieved a Clinical Response at Week 4

    A clinical response is defined as a decrease from baseline in CDAI ≥ 100 points. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined \>450.

    Time frame: Week 4

  5. The Percentage of Participants Who Achieved a Clinical Remission at Week 4

    A clinical remission is a CDAI score \< 150. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined \>450.

    Time frame: Week 4

  6. The Percentage of Participants Who Achieved a Corticosteroid-Free Clinical Remission at Week 52

    The percentage of participants who were receiving oral corticosteroids for Crohn's disease, at baseline and achieved a clinical remission (CDAI score \<150) at Week 52 without corticosteroids. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined \>450.

    Time frame: Week 52

  7. Percentage of Participants Who Achieved a Sustained Clinical Remission at Both Week 12 and 52

    For participants who achieved a sustained clinical remission at both week 12 and 52, the clinical remission is a CDAI score \< 150. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined \>450.

    Time frame: Weeks 12 and 52

  8. Percentage of Participants With Endoscopic Response-25 Centrally Read at Week 12

    An endoscopic response-25 is defined as a reduction of at least 25% compared with baseline in simple endoscopic score for Crohn's disease (SES-CD). The SES-CD assesses the size of mucosal ulcers, the extent of ulcerated surface, the extent of affected surface, and the presence and type of narrowings. Scores range from 0 to 60 with higher scores reflecting more severe disease. The SES-CD calculations include: * Ulcers scored as: 0: no 1. aphthous (0.1-0.5 cm) 2. large (0.5-2 cm) 3. very large (\>2 cm) * Surface involved disease 0: 0% 1. \<50% 2. 50-75% 3. \>75% Surface involved by ulcerations: 0: 0% 1. \<10% 2. 10-30% 3. \>30% - Narrowings: 0: No 1. Single, can be passed 2. Multiple, can be passed 3. Cannot be passed Grand Total = SES-CD score

    Time frame: Week 0, Week 12

  9. Percentage of Participants With Endoscopic Remission Centrally Read at Week 52

    Endoscopic remission is defined as a simple endoscopic score for Crohn's disease (SES-CD) of ≤2 at the specified timeframe. The SES-CD assesses the size of mucosal ulcers, the extent of ulcerated surface, the extent of affected surface, and the presence and type of narrowings. Scores range from 0 to 60 with higher scores reflecting more severe disease. The SES-CD calculations include: * Ulcers scored as: 0: no 1. aphthous (0.1-0.5 cm) 2. large (0.5-2 cm) 3. very large (\>2 cm) * Surface involved disease 0: 0% 1. \<50% 2. 50-75% 3. \>75% Surface involved by ulcerations: 0: 0% 1. \<10% 2. 10-30% 3. \>30% - Narrowings: 0: No 1. Single, can be passed 2. Multiple, can be passed 3. Cannot be passed Grand Total = SES-CD score

    Time frame: Week 52

  10. The Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAE) From Week 0 to Week 52

    A TEAE was defined as any adverse event (AE) occurring or worsening on or after the first treatment of GED-0301 and up to 28 days after the last GED-0301 dose or the last follow-up date, whichever occurred earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event.

    Time frame: From the first day of GED-0301 until 28 days after the last dose of investigational product (IP); maximum treatment duration was 52.6 weeks

  11. The Number of Participants Who Discontinued IP Due to an Treatment Emergent Adverse Events

    A TEAE was defined as any AE occurring or worsening on or after the first dose of GED-0301 and up to 28 days after the last GED-0301 dose or the last follow-up date, whichever occurred earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = asymptomatic or mild symptoms; clinical or diagnostic observations only; Moderate = Symptoms cause moderate discomfort; Severe (could be non-serious or serious) = symptoms causing severe discomfort/pain.

    Time frame: From the first day of GED-0301 until 28 days after the last dose of IP; maximum treatment duration was 52.6 weeks

07

Results

Posted Jan 23, 2019
Limitations and caveats
Following a recommendation by the DMC, this study was terminated early by the sponsor on 19 Oct 2017 due to a lack of emerging benefit; no emergent safety findings were noted.

Participant flow

Participants were enrolled at study centers within the United States and Canada, Australia, Eastern and Western Europe, Korea and Russia.

Overall Double-Blind Period Weeks 0-52
Participant flow — Overall Double-Blind Period Weeks 0-52
MilestonePlaceboGED-0301 160 mg / GED-0301 40 mg 4 Week AltGED-0301 160 mg / GED-0301 40 mgGED-0301 160 mg / GED-0301 160 mg 4 Week Alt
Started174176176175
Completed108149
Not completed164168162166
Withdrew: Study terminated by sponsor61564858
Withdrew: Adverse event11151512
Withdrew: Pregnancy0001
Withdrew: Lack of efficacy15141413
Withdrew: Withdrawal by subject104135
Withdrew: Miscellaneous1202
Withdrew: Lost to follow-up0111
Withdrew: Non-compliance with study drug0012
Withdrew: Death0010
Withdrew: Protocol violation0002
Withdrew: Early escape66766970
Follow-Up Period Weeks 0 to 52
Participant flow — Follow-Up Period Weeks 0 to 52
MilestonePlaceboGED-0301 160 mg / GED-0301 40 mg 4 Week AltGED-0301 160 mg / GED-0301 40 mgGED-0301 160 mg / GED-0301 160 mg 4 Week Alt
Started57515647
Completed57515647
Not completed0000

Outcome measures

SecondaryPercentage of Participants Who Achieved Clinical Remission at Week 52

Clinical remission is defined as a CDAI score \< 150 and is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined \>450.

Time frame:
Week 52
Reported as:
Number · percentage of participants
Percentage of Participants Who Achieved Clinical Remission at Week 52
percentage of participantsPlaceboGED-0301 160 mg / GED-0301 40 mg 4 Week AltGED-0301 160 mg / GED-0301 40 mgGED-0301 160 mg / GED-0301 160 mg 4 Week Alt
Percentage of Participants Who Achieved Clinical Remission at Week 525.3 (2.5 to 11.1)2.5 (0.9 to 7.1)9.4 (5.4 to 15.7)3.4 (1.3 to 8.5)
Statistical analysis
  • Placebo vs GED-0301 160 mg / GED-0301 40 mg 4 Week Alt · Cochran-Mantel-Haenszel · p = 0.2523 · Stratified difference: -2.9 · 95% CI -9.7 to 3.9The weighted average of the treatment differences across the strata with the CMH weights.
  • Placebo vs GED-0301 160 mg / GED-0301 40 mg · Cochran-Mantel-Haenszel · p = 0.1626 · Slope: 4.8 · 95% CI -3.0 to 11.8The weighted average of the treatment differences across the strata with the CMH weights.
  • Placebo vs GED-0301 160 mg / GED-0301 160 mg 4 Week Alt · Cochran-Mantel-Haenszel · p = 0.4420 · Stratified difference: -2.1 · 95% CI -9.1 to 5.3The weighted average of the treatment differences across the strata with the CMH weights.
SecondaryPercentage of Participants With Endoscopic Response-50 Centrally Read at Week 52

An endoscopic response-50 is defined as a reduction of at least 50% compared with baseline in simple endoscopic score for Crohn's Disease (SES-CD). The SES-CD assesses the size of mucosal ulcers, the extent of ulcerated surface, the extent of affected surface, and the presence and type of narrowings. Scores range from 0 to 60 with higher scores reflecting more severe disease. The SES-CD calculations include: * Ulcers scored as: 0: no 1. aphthous (0.1-0.5 cm) 2. large (0.5-2 cm) 3. very large (\>2 cm) * Surface involved disease 0: 0% 1. \<50% 2. 50-75% 3. \>75% Surface involved by ulcerations: 0: 0% 1. \<10% 2. 10-30% 3. \>30% - Narrowings: 0: No 1. Single, can be passed 2. Multiple, can be passed 3. Cannot be passed Grand Total = SES-CD score

Time frame:
Week 52
Reported as:
Number · percentage of participants
Percentage of Participants With Endoscopic Response-50 Centrally Read at Week 52
percentage of participantsPlaceboGED-0301 160 mg / GED-0301 40 mg 4 Week AltGED-0301 160 mg / GED-0301 40 mgGED-0301 160 mg / GED-0301 160 mg 4 Week Alt
Percentage of Participants With Endoscopic Response-50 Centrally Read at Week 523.5 (1.4 to 8.7)0.8 (0.1 to 4.6)1.6 (0.4 to 5.5)1.7 (0.5 to 6.0)
Statistical analysis
  • Placebo vs GED-0301 160 mg / GED-0301 40 mg 4 Week Alt · Cochran-Mantel-Haenszel · p = 0.1799 · Stratified difference: -2.6 · 95% CI -9.5 to 5.0The weighted average of the treatment differences across the strata with the CMH weights.
  • Placebo vs GED-0301 160 mg / GED-0301 40 mg · Cochran-Mantel-Haenszel · p = 0.2309 · Stratified difference: -2.4 · 95% CI -9.4 to 4.9The weighted average of the treatment differences across the strata with the CMH weights.
  • Placebo vs GED-0301 160 mg / GED-0301 160 mg 4 Week Alt · Cochran-Mantel-Haenszel · p = 0.3264 · Stratified difference: -2.1 · 95% CI -9.1 to 4.6The weighted average of the treatment differences across the strata with the CMH weights.
SecondaryThe Percentage of Participants Who Achieved a Clinical Response at Week 12

A clinical response is defined as a CDAI score decrease from baseline ≥ 100 points. The CDAI is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined \>450.

Time frame:
Week 12
Reported as:
Number · percentage of participants
The Percentage of Participants Who Achieved a Clinical Response at Week 12
percentage of participantsPlaceboGED-0301 160 mg / GED-0301 40 mg 4 Week AltGED-0301 160 mg / GED-0301 40 mgGED-0301 160 mg / GED-0301 160 mg 4 Week Alt
The Percentage of Participants Who Achieved a Clinical Response at Week 1244.4 (36.9 to 52.1)32.1 (25.4 to 39.6)34.1 (27.3 to 41.7)33.8 (26.8 to 41.5)
Statistical analysis
  • Placebo vs GED-0301 160 mg / GED-0301 40 mg 4 Week Alt · Cochran-Mantel-Haenszel · p = 0.0299 · Stratified difference: -11.7 · 95% CI -22.0 to -1.1The weighted average of the treatment differences across the strata with the CMH weights.
  • Placebo vs GED-0301 160 mg / GED-0301 40 mg · Cochran-Mantel-Haenszel · p = 0.0582 · Stratified difference: -9.9 · 95% CI -20.3 to 0.7The weighted average of the treatment differences across the strata with the CMH weights.
  • Placebo vs GED-0301 160 mg / GED-0301 160 mg 4 Week Alt · Cochran-Mantel-Haenszel · p = 0.0741 · Stratified difference: -9.7 · 95% CI -20.1 to 1.0The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.
SecondaryThe Percentage of Participants Who Achieved a Clinical Response at Week 4

A clinical response is defined as a decrease from baseline in CDAI ≥ 100 points. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined \>450.

Time frame:
Week 4
Reported as:
Number · percentage of participants
The Percentage of Participants Who Achieved a Clinical Response at Week 4
percentage of participantsPlaceboGED-0301 160 mg / GED-0301 40 mg 4 Week AltGED-0301 160 mg / GED-0301 40 mgGED-0301 160 mg / GED-0301 160 mg 4 Week Alt
The Percentage of Participants Who Achieved a Clinical Response at Week 434.3 (27.6 to 41.8)28.5 (22.3 to 35.6)32.4 (25.8 to 39.7)27.8 (21.6 to 35.0)
Statistical analysis
  • Placebo vs GED-0301 160 mg / GED-0301 40 mg 4 Week Alt · Cochran-Mantel-Haenszel · p = 0.2493 · Stratified difference: -5.8 · 95% CI -15.5 to 4.0The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.
  • Placebo vs GED-0301 160 mg / GED-0301 40 mg · Cochran-Mantel-Haenszel · p = 0.7160 · Stratified difference: -1.8 · 95% CI -11.8 to 8.2The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.
  • Placebo vs GED-0301 160 mg / GED-0301 160 mg 4 Week Alt · Cochran-Mantel-Haenszel · p = 0.2452 · Stratified difference: -5.8 · 95% CI -15.5 to 4.1The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.
SecondaryThe Percentage of Participants Who Achieved a Clinical Remission at Week 4

A clinical remission is a CDAI score \< 150. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined \>450.

Time frame:
Week 4
Reported as:
Number · percentage of participants
The Percentage of Participants Who Achieved a Clinical Remission at Week 4
percentage of participantsPlaceboGED-0301 160 mg / GED-0301 40 mg 4 Week AltGED-0301 160 mg / GED-0301 40 mgGED-0301 160 mg / GED-0301 160 mg 4 Week Alt
The Percentage of Participants Who Achieved a Clinical Remission at Week 420.1 (14.8 to 26.8)18.6 (13.5 to 25.1)16.5 (11.6 to 22.8)15.4 (10.7 to 21.6)
Statistical analysis
  • Placebo vs GED-0301 160 mg / GED-0301 40 mg 4 Week Alt · Cochran-Mantel-Haenszel · p = 0.7541 · Stratified difference: -1.3 · 95% CI -9.8 to 7.1The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.
  • Placebo vs GED-0301 160 mg / GED-0301 40 mg · Cochran-Mantel-Haenszel · p = 0.3784 · Stratified difference: -3.7 · 95% CI -12.0 to 4.6The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.
  • Placebo vs GED-0301 160 mg / GED-0301 160 mg 4 Week Alt · Cochran-Mantel-Haenszel · p = 0.2865 · Stratified difference: -4.4 · 95% CI -12.6 to 3.8The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.
SecondaryThe Percentage of Participants Who Achieved a Corticosteroid-Free Clinical Remission at Week 52

The percentage of participants who were receiving oral corticosteroids for Crohn's disease, at baseline and achieved a clinical remission (CDAI score \<150) at Week 52 without corticosteroids. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined \>450.

Time frame:
Week 52
Reported as:
Number · percentage of participants
The Percentage of Participants Who Achieved a Corticosteroid-Free Clinical Remission at Week 52
percentage of participantsPlaceboGED-0301 160 mg / GED-0301 40 mg 4 Week AltGED-0301 160 mg / GED-0301 40 mgGED-0301 160 mg / GED-0301 160 mg 4 Week Alt
The Percentage of Participants Who Achieved a Corticosteroid-Free Clinical Remission at Week 522.2 (0.4 to 11.3)0.0 (0.0 to 9.0)7.0 (2.4 to 18.6)2.4 (0.4 to 12.3)
Statistical analysis
  • Placebo vs GED-0301 160 mg / GED-0301 40 mg 4 Week Alt · Cochran-Mantel-Haenszel · p = 0.3572 · Unstratified cmh: -2.2 · 95% CI -11.3 to 7.0The weighted average of the treatment differences across the strata with the CMH weights.
  • Placebo vs GED-0301 160 mg / GED-0301 40 mg · Cochran-Mantel-Haenszel · p = 0.2823 · Stratified difference: 4.7 · 95% CI -8.8 to 18.9The weighted average of the treatment differences across the strata with the CMH weights.
  • Placebo vs GED-0301 160 mg / GED-0301 160 mg 4 Week Alt · Cochran-Mantel-Haenszel · p = > 0.9999 · Stratified difference: 0.0 · 95% CI -12.8 to 13.7The weighted average of the treatment differences across the strata with the CMH weights.
SecondaryPercentage of Participants Who Achieved a Sustained Clinical Remission at Both Week 12 and 52

For participants who achieved a sustained clinical remission at both week 12 and 52, the clinical remission is a CDAI score \< 150. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined \>450.

Time frame:
Weeks 12 and 52
Reported as:
Number · percentage of participants
Percentage of Participants Who Achieved a Sustained Clinical Remission at Both Week 12 and 52
percentage of participantsPlaceboGED-0301 160 mg / GED-0301 40 mg 4 Week AltGED-0301 160 mg / GED-0301 40 mgGED-0301 160 mg / GED-0301 160 mg 4 Week Alt
Percentage of Participants Who Achieved a Sustained Clinical Remission at Both Week 12 and 522.7 (0.9 to 7.5)2.5 (0.9 to 7.1)3.9 (1.7 to 8.8)1.7 (0.5 to 5.0)
Statistical analysis
  • Placebo vs GED-0301 160 mg / GED-0301 40 mg 4 Week Alt · Cochran-Mantel-Haenszel · p = 0.8031 · Stratified difference: -0.5 · 95% CI -6.7 to 5.9The weighted average of the treatment differences across the strata with the CMH weights.
  • Placebo vs GED-0301 160 mg / GED-0301 40 mg · Cochran-Mantel-Haenszel · p = 0.5583 · Stratified difference: 1.4 · 95% CI -5.1 to 7.3The weighted average of the treatment differences across the strata with the CMH weights.
  • Placebo vs GED-0301 160 mg / GED-0301 160 mg 4 Week Alt · Cochran-Mantel-Haenszel · p = 0.6123 · Stratified difference: -1.0 · 95% CI -7.2 to 6.8
SecondaryPercentage of Participants With Endoscopic Response-25 Centrally Read at Week 12

An endoscopic response-25 is defined as a reduction of at least 25% compared with baseline in simple endoscopic score for Crohn's disease (SES-CD). The SES-CD assesses the size of mucosal ulcers, the extent of ulcerated surface, the extent of affected surface, and the presence and type of narrowings. Scores range from 0 to 60 with higher scores reflecting more severe disease. The SES-CD calculations include: * Ulcers scored as: 0: no 1. aphthous (0.1-0.5 cm) 2. large (0.5-2 cm) 3. very large (\>2 cm) * Surface involved disease 0: 0% 1. \<50% 2. 50-75% 3. \>75% Surface involved by ulcerations: 0: 0% 1. \<10% 2. 10-30% 3. \>30% - Narrowings: 0: No 1. Single, can be passed 2. Multiple, can be passed 3. Cannot be passed Grand Total = SES-CD score

Time frame:
Week 0, Week 12
Reported as:
Number · percentage of participants
Percentage of Participants With Endoscopic Response-25 Centrally Read at Week 12
percentage of participantsPlaceboGED-0301 160 mg / GED-0301 40 mg 4 Week AltGED-0301 160 mg / GED-0301 40 mgGED-0301 160 mg / GED-0301 160 mg 4 Week Alt
Percentage of Participants With Endoscopic Response-25 Centrally Read at Week 1228.1 (21.7 to 35.5)17.3 (12.2 to 23.8)27.4 (21.2 to 34.7)24.2 (18.2 to 31.5)
Statistical analysis
  • Placebo vs GED-0301 160 mg / GED-0301 40 mg 4 Week Alt · Cochran-Mantel-Haenszel · p = 0.0239 · Stratified difference: -10.6 · 95% CI -19.6 to -1.4The weighted average of the treatment differences across the strata with the CMH weights.
  • Placebo vs GED-0301 160 mg / GED-0301 40 mg · Cochran-Mantel-Haenszel · p = 0.8334 · Stratified difference: -1.0 · 95% CI -10.8 to 8.7The weighted average of the treatment differences across the strata with the CMH weights.
  • Placebo vs GED-0301 160 mg / GED-0301 160 mg 4 Week Alt · Cochran-Mantel-Haenszel · p = 0.4383 · Stratified difference: -3.9 · 95% CI -13.5 to 5.8The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.
SecondaryPercentage of Participants With Endoscopic Remission Centrally Read at Week 52

Endoscopic remission is defined as a simple endoscopic score for Crohn's disease (SES-CD) of ≤2 at the specified timeframe. The SES-CD assesses the size of mucosal ulcers, the extent of ulcerated surface, the extent of affected surface, and the presence and type of narrowings. Scores range from 0 to 60 with higher scores reflecting more severe disease. The SES-CD calculations include: * Ulcers scored as: 0: no 1. aphthous (0.1-0.5 cm) 2. large (0.5-2 cm) 3. very large (\>2 cm) * Surface involved disease 0: 0% 1. \<50% 2. 50-75% 3. \>75% Surface involved by ulcerations: 0: 0% 1. \<10% 2. 10-30% 3. \>30% - Narrowings: 0: No 1. Single, can be passed 2. Multiple, can be passed 3. Cannot be passed Grand Total = SES-CD score

Time frame:
Week 52
Reported as:
Number · percentage of participants
Percentage of Participants With Endoscopic Remission Centrally Read at Week 52
percentage of participantsPlaceboGED-0301 160 mg / GED-0301 40 mg 4 Week AltGED-0301 160 mg / GED-0301 40 mgGED-0301 160 mg / GED-0301 160 mg 4 Week Alt
Percentage of Participants With Endoscopic Remission Centrally Read at Week 522.7 (0.9 to 7.5)0.8 (0.1 to 4.6)0.8 (0.1 to 4.3)0.9 (0.2 to 4.7)
Statistical analysis
  • Placebo vs GED-0301 160 mg / GED-0301 40 mg 4 Week Alt · Cochran-Mantel-Haenszel · p = 0.3573 · Stratified difference: -1.6 · 95% CI -8.3 to 5.9The weighted average of the treatment differences across the strata with CMH weights.
  • Placebo vs GED-0301 160 mg / GED-0301 40 mg · Cochran-Mantel-Haenszel · p = 0.2221 · Stratified difference: -2.0 · 95% CI -8.7 to 5.1The weighted average of the treatment differences across the strata with the CMH weights.
  • Placebo vs GED-0301 160 mg / GED-0301 160 mg 4 Week Alt · Cochran-Mantel-Haenszel · p = 0.2578 · Stratified difference: -2.0 · 95% CI -8.7 to 5.6The weighted average of the treatment differences across the strata with the CMH weights.
SecondaryThe Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAE) From Week 0 to Week 52

A TEAE was defined as any adverse event (AE) occurring or worsening on or after the first treatment of GED-0301 and up to 28 days after the last GED-0301 dose or the last follow-up date, whichever occurred earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event.

Time frame:
From the first day of GED-0301 until 28 days after the last dose of investigational product (IP); maximum treatment duration was 52.6 weeks
Reported as:
Count of participants · Participants
The Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAE) From Week 0 to Week 52
ParticipantsPlaceboGED-0301 160 mg / GED-0301 40 mg 4 Week AltGED-0301 160 mg / GED-0301 40 mgGED-0301 160 mg / GED-0301 160 mg 4 Week Alt
Any TEAE124128129113
Any IP-Related TEAE31353020
Any Severe TEAE14222115
Any Serious TEAE (SAE)16282215
Any Serious IP-Related TEAE3220
Any TEAE Leading to IP Withdrawal11151612
Any TEAE Leading to IP Interruption4454
Any TEAE Leading to Death0011
SecondaryThe Number of Participants Who Discontinued IP Due to an Treatment Emergent Adverse Events

A TEAE was defined as any AE occurring or worsening on or after the first dose of GED-0301 and up to 28 days after the last GED-0301 dose or the last follow-up date, whichever occurred earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = asymptomatic or mild symptoms; clinical or diagnostic observations only; Moderate = Symptoms cause moderate discomfort; Severe (could be non-serious or serious) = symptoms causing severe discomfort/pain.

Time frame:
From the first day of GED-0301 until 28 days after the last dose of IP; maximum treatment duration was 52.6 weeks
Reported as:
Number · participants
The Number of Participants Who Discontinued IP Due to an Treatment Emergent Adverse Events
participantsPlaceboGED-0301 160 mg / GED-0301 40 mg 4 Week AltGED-0301 160 mg / GED-0301 40 mgGED-0301 160 mg / GED-0301 160 mg 4 Week Alt
The Number of Participants Who Discontinued IP Due to an Treatment Emergent Adverse Events11151612
PrimaryThe Percentage of Participants Who Achieved a Clinical Remission at Week 12

Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score \< 150. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the affect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined \>450.

Time frame:
Week 12
Reported as:
Number · Percentage of Participants
The Percentage of Participants Who Achieved a Clinical Remission at Week 12
Percentage of ParticipantsPlaceboGED-0301 160 mg / GED-0301 40 mg 4 Week AltGED-0301 160 mg / GED-0301 40 mgGED-0301 160 mg / GED-0301 160 mg 4 Week Alt
The Percentage of Participants Who Achieved a Clinical Remission at Week 1225.0 (18.9 to 32.2)25.3 (19.2 to 32.5)21.3 (15.8 to 28.2)21.7 (15.9 to 28.7)
Statistical analysis
  • Placebo vs GED-0301 160 mg / GED-0301 40 mg 4 Week Alt · Cochran-Mantel-Haenszel · p = 0.9141 · Stratified difference: 0.5 · 95% CI -8.9 to 10.0The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights
  • Placebo vs GED-0301 160 mg / GED-0301 40 mg · Cochran-Mantel-Haenszel · p = 0.4286 · Stratified difference: -3.6 · 95% CI -12.8 to 5.6The weighted average of the treatment differences across the strata with the CMH weights.
  • Placebo vs GED-0301 160 mg / GED-0301 160 mg 4 Week Alt · Cochran-Mantel-Haenszel · p = 0.5591 · Stratified difference: -2.7 · 95% CI -12.0 to 6.6The weighted average of the treatment differences across the strata with the CMH weights.

Adverse events

Collected over From day 1 of GED-0301 until 28 days after the last dose of IP as well as those SAEs made known to the Investigator at any time thereafter that are suspected of being related to IP.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/174 (0%)16/174 (9.2%)78/174 (44.8%)
GED-0301 160 mg / GED-0301 40 mg 4 Week Alt0/176 (0%)28/176 (15.9%)72/176 (40.9%)
GED-0301 160 mg / GED-0301 40 mg1/176 (0.6%)22/176 (12.5%)74/176 (42%)
GED-0301 160 mg / GED-0301 160 mg 4 Week Alt1/175 (0.6%)15/175 (8.6%)63/175 (36%)
Most frequent serious events
Showing 10 of 52
Most frequent serious events
EventPlaceboGED-0301 160 mg / GED-0301 40 mg 4 Week AltGED-0301 160 mg / GED-0301 40 mgGED-0301 160 mg / GED-0301 160 mg 4 Week Alt
CROHN'S DISEASEGastrointestinal disorders4/1749/1768/1765/175
ABDOMINAL PAINGastrointestinal disorders3/1741/1761/1762/175
VOMITINGGastrointestinal disorders2/1740/1760/1761/175
SMALL INTESTINAL OBSTRUCTIONGastrointestinal disorders1/1742/1761/1762/175
ANAL FISTULAGastrointestinal disorders0/1742/1762/1760/175
LARGE INTESTINAL STENOSISGastrointestinal disorders1/1740/1760/1760/175
MELAENAGastrointestinal disorders1/1740/1760/1760/175
ANAL ABSCESSInfections and infestations1/1741/1761/1760/175
CELLULITISInfections and infestations1/1740/1760/1761/175
EPSTEIN-BARR VIRUS INFECTIONInfections and infestations1/1740/1760/1760/175
Most frequent other events
Most frequent other events
EventPlaceboGED-0301 160 mg / GED-0301 40 mg 4 Week AltGED-0301 160 mg / GED-0301 40 mgGED-0301 160 mg / GED-0301 160 mg 4 Week Alt
ARTHRALGIAMusculoskeletal and connective tissue disorders15/17420/17623/17625/175
ABDOMINAL PAINGastrointestinal disorders19/17420/17614/17615/175
VIRAL UPPER RESPIRATORY TRACT INFECTIONInfections and infestations15/17418/17614/17616/175
CROHN'S DISEASEGastrointestinal disorders15/17414/17614/17615/175
HEADACHENervous system disorders15/17410/17612/1769/175
PYREXIAGeneral disorders10/17413/17614/1760/175
NAUSEAGastrointestinal disorders12/1749/17610/1769/175
DIARRHOEAGastrointestinal disorders0/17410/1760/1760/175
BACK PAINMusculoskeletal and connective tissue disorders9/1740/1760/1760/175

Baseline characteristics

Intent to Treat (ITT) population consisted of all participants who were randomized and received at least 1 dose of investigational product (IP). Treatment assignment at Week 0 visit was based on concomitant use of corticosteroids (yes/no), concomitant use of immunosuppressants (yes/no) or and previous exposure to biologics (yes/no),

Age, Continuous
Age, Continuous(Years)PlaceboGED-0301 160 mg / GED-0301 40 mg 4 Week AltGED-0301 160 mg / GED-0301 40 mgGED-0301 160 mg / GED-0301 160 mg 4 Week AltTotal
Mean38.5 ± 12.8837.6 ± 12.8439.6 ± 12.9038.2 ± 12.4738.5 ± 12.77
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboGED-0301 160 mg / GED-0301 40 mg 4 Week AltGED-0301 160 mg / GED-0301 40 mgGED-0301 160 mg / GED-0301 160 mg 4 Week AltTotal
Female76989280346
Male98788495355
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)PlaceboGED-0301 160 mg / GED-0301 40 mg 4 Week AltGED-0301 160 mg / GED-0301 40 mgGED-0301 160 mg / GED-0301 160 mg 4 Week AltTotal
American Indian or Alaska Native10102
Asian1128829
Black or African American442212
White150165152158625
Not Collected or Reported549523
Other (No classification)314210
Duration of Crohn's Disease
Duration of Crohn's Disease(Years)PlaceboGED-0301 160 mg / GED-0301 40 mg 4 Week AltGED-0301 160 mg / GED-0301 40 mgGED-0301 160 mg / GED-0301 160 mg 4 Week AltTotal
Mean9.57 ± 9.1068.63 ± 7.8779.84 ± 8.74610.15 ± 9.3539.54 ± 8.786
Baseline Crohn's Disease Activity (CDAI) Score
Baseline Crohn's Disease Activity (CDAI) Score(Units on a Scale)PlaceboGED-0301 160 mg / GED-0301 40 mg 4 Week AltGED-0301 160 mg / GED-0301 40 mgGED-0301 160 mg / GED-0301 160 mg 4 Week AltTotal
Mean307.9 ± 64.31292.8 ± 69.33308.3 ± 65.50309.9 ± 66.32304.7 ± 66.61
Baseline Endoscopic Score for Crohn's Disease (Central Read)
Baseline Endoscopic Score for Crohn's Disease (Central Read)(Units on a Scale)PlaceboGED-0301 160 mg / GED-0301 40 mg 4 Week AltGED-0301 160 mg / GED-0301 40 mgGED-0301 160 mg / GED-0301 160 mg 4 Week AltTotal
Mean14.4 ± 7.8814.3 ± 8.4113.8 ± 7.6914.5 ± 8.3014.2 ± 8.06
08

Study locations

538 sites
  • ADDC Research LLC
    Huntsville, Alabama 35802, United States
  • Arizona Digestive Health
    Mesa, Arizona 85024, United States
  • Mayo Clinic Arizona
    Phoenix, Arizona 85054, United States
  • Colon & Digestive Health Specialists
    Scottsdale, Arizona 85260-1315, United States
  • Arizona Digestive Health
    Sun City, Arizona 85351, United States
  • Gastroenterology Associates PA
    Little Rock, Arkansas 72205, United States
  • HCP Clinical Research LLC
    Anaheim, California 92801, United States
  • T. Joseph Raoof MD Inc
    Encino, California 91436, United States
  • Valley View Internal Medicine
    Garden Grove, California 92843, United States
  • OM Research
    Lancaster, California 93534, United States
  • University of Southern California Medical Center
    Los Angeles, California 90032, United States
  • Cedars-Sinai Medical Center
    Los Angeles, California 90048, United States
  • Facey Medical Foundation
    Mission Hills, California 91345, United States
  • Medical Associates Research Group Inc.
    San Diego, California 902123, United States
  • Clinical Applications Laboratories Inc
    San Diego, California 92103, United States
  • University of California at San Francisco
    San Francisco, California 94158, United States
  • Ventura Clinical Trials
    Ventura, California 93003, United States
  • University Of Colorado
    Aurora, Colorado 80045, United States
  • Innovative Clinical Research
    Lafayette, Colorado 80026, United States
  • Connecticut Gastroenterology Institute
    Bristol, Connecticut 06010, United States
  • Medical Research Center of Connecticut LLC
    Hamden, Connecticut 06518, United States
  • Connecticut GI PC Research Division
    Hartford, Connecticut 06106, United States
  • Yale University
    New Haven, Connecticut 06520, United States
  • Florida Medical Research - Southeastern Integrated Medical
    Gainesville, Florida 32607, United States
  • Sarkis Clinical Trials - Parent
    Gainesville, Florida 32607, United States
  • Borland-Groover Clinic
    Jacksonville, Florida 32256, United States
  • Florida Center for Gastroenterology
    Largo, Florida 33777, United States
  • Galiz Research LLC
    Miami Springs, Florida 33166, United States
  • Advance Medical Research Center
    Miami, Florida 33155, United States
  • Cordova Research Institute
    Miami, Florida 33155, United States
  • My Community Research Center inc
    Miami, Florida 33155, United States
  • Sanitas Research
    Miami, Florida 33155, United States
  • Gastroenterology Group of Naples
    Naples, Florida 34102, United States
  • GCRM
    Orlando, Florida 32801, United States
  • Center For Digestive Health
    Orlando, Florida 32803, United States
  • BRCR Medical Center Inc.
    Plantation, Florida 33322, United States
  • Advanced Medical Research Center
    Port Orange, Florida 32127, United States
  • East Coast Institute for Research LLC
    Saint Augustine, Florida 32086, United States
  • Cleveland Clinic Florida Weston
    Weston, Florida 33331, United States
  • Shafran Gastroenterology Center
    Winter Park, Florida 32789, United States
  • Atlanta Gastroenterology Associates, LLC
    Atlanta, Georgia 30342, United States
  • Georgia Regents University
    Augusta, Georgia 30912, United States
  • Columbus Regional Research Institute
    Columbus, Georgia 31904, United States
  • Atlanta Gastroenterology Specialists PC
    Suwanee, Georgia 30024, United States
  • Grand Teton Research Group PLLC
    Idaho Falls, Idaho 83404, United States
  • Northwestern University-Feinberg School of Medicine
    Chicago, Illinois 60611, United States
  • University of Chicago Medical Center
    Chicago, Illinois 60637, United States
  • NorthShore University HealthSystem
    Highland Park, Illinois 60035, United States
  • Indiana University
    Indianapolis, Indiana 46202, United States
  • Iowa Digestive Disease Center
    Clive, Iowa 50325, United States
  • Health Science Research Center, LLC
    Pratt, Kansas 67124, United States
  • Heartland Research Associates LLC
    Wichita, Kansas 67207, United States
  • Via Christi Research a division of Via Christi Hospitals Wichita Inc
    Wichita, Kansas 67208, United States
  • Graves Gilbert Clinic
    Bowling Green, Kentucky 42101, United States
  • University of Kentucky Medical Center
    Lexington, Kentucky 40504, United States
  • University of Louisville
    Louisville, Kentucky 40202, United States
  • Gastroenterology Associates LLC
    Baton Rouge, Louisiana 70809, United States
  • Clinical Trials of SW Louisiana LLC
    Lake Charles, Louisiana 70601, United States
  • Louisiana Research Center LLC
    Shreveport, Louisiana 71103, United States
  • University of Maryland Medical Center
    Baltimore, Maryland 21201, United States
  • Johns Hopkins University School of Medicine
    Baltimore, Maryland 21218, United States
  • Metropolitan Gastroenterology
    Chevy Chase, Maryland 20815, United States
  • Gastro Center of Maryland
    Columbia, Maryland 21045, United States
  • Boston Medical Center
    Boston, Massachusetts 02118, United States
  • Commonwealth Clinical Studies PLLC
    Brockton, Massachusetts 02302, United States
  • UMass Medical Center
    Worcester, Massachusetts 01655, United States
  • University of Michigan Health System
    Ann Arbor, Michigan 48109, United States
  • Medex Research Institute
    Caro, Michigan 48723, United States
  • Clinical Research Institute of Michigan, LLC
    Chesterfield, Michigan 48047, United States
  • Henry Ford Medical Center - New Center One
    Novi, Michigan 48377, United States
  • Gastroenterology Associates of Western Michigan PLC
    Wyoming, Michigan 49519, United States
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Ehrhardt Clinical Research LLC
    Belton, Missouri 64012, United States
  • Jefferson City Medical Group
    Jefferson City, Missouri 65203, United States
  • Saint Louis University
    Saint Louis, Missouri 63110 - 0250, United States
  • Mercy Research
    Springfield, Missouri 65806, United States
  • Mercy Clinic East Communities d/b/a Mercy Health Research
    Washington, Missouri 63090, United States
  • Dartmouth-Hitchcock Medical Center
    Lebanon, New Hampshire 03756, United States
  • AGA Clinical Research Associates LLC
    Egg Harbor Township, New Jersey 08234, United States
  • Southwest Gastroenterology Associates PC
    Albuquerque, New Mexico 87109, United States
  • Sing Chan Private Practice
    Flushing, New York 11355, United States
  • NYU Langone Nassau Gastroenterology Associates
    Great Neck, New York 11021, United States
  • Montefiore Medical Center PRIME
    Lake Success, New York 11041, United States
  • The Feinstein Institute for Medical Research PRIME
    Manhasset, New York 11030, United States
  • Winthrop University Hospital
    Mineola, New York 11501, United States
  • North Shore Long Island Jewish Health System
    New Hyde Park, New York 11040, United States
  • Concord Medical Group PRIME
    New York, New York 10016, United States
  • New York University School of Medicine
    New York, New York 10016, United States
  • New York - Presbyterian/Weill Cornell Medical Center
    New York, New York 10021, United States
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10029, United States
  • Columbia University Medical Center
    New York, New York 10032, United States
  • Premier Medical Group of the Hudson Valley PC
    Poughkeepsie, New York 12601, United States
  • University of Rochester
    Rochester, New York 14642, United States
  • Asheville Gastroenterology Associates, PA
    Asheville, North Carolina 28801, United States
  • University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina 27514, United States
  • Carolina Center for Liver Disease
    Charlotte, North Carolina 28203, United States
  • Gaffney Health Services
    Charlotte, North Carolina 28205, United States
  • Carolinas Medical Center
    Charlotte, North Carolina 28207, United States
  • PhysiqueMed Clinical Trials
    Greensboro, North Carolina 27455, United States

Showing the first 100 of 538 sites across 35 countries.

09

References and documents

Publications

  • Gold SL, Cohen-Mekelburg S, Schneider Y, Steinlauf A. Perianal Fistulas in Patients With Crohn's Disease, Part 2: Surgical, Endoscopic, and Future Therapies. Gastroenterol Hepatol (N Y). 2018 Sep;14(9):521-528. PubMed 30364296 ↗
  • Sands BE, Feagan BG, Sandborn WJ, Schreiber S, Peyrin-Biroulet L, Frederic Colombel J, Rossiter G, Usiskin K, Ather S, Zhan X, D'Haens G. Mongersen (GED-0301) for Active Crohn's Disease: Results of a Phase 3 Study. Am J Gastroenterol. 2020 May;115(5):738-745. doi: 10.14309/ajg.0000000000000493. PubMed 31850931 ↗

Study documents

  • Study protocol · Aug 15, 2017
  • Statistical analysis plan · Mar 20, 2018

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02596893
Lead sponsor
Celgene
Responsible party
Sponsor
First posted
Nov 4, 2015
Start date
Dec 8, 2015
Primary completion
Jan 5, 2018
Completion
Jan 5, 2018
Results posted
Jan 23, 2019
Last update
Aug 28, 2019

Study contacts

Guillermo Rossiter, MD
study director · Celgene Corporation

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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