Crohn DiseasePhase 2RELIEVE UCCDNCT05499130
A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease
A Phase 2 study testing TEV-48574 in people with Crohn Disease and Colitis, Ulcerative, run by Teva Branded Pharmaceutical Products R&D, Inc. at 164 sites in 19 countries.
Trial summary
The primary objective is to characterize the efficacy TEV-48574 in adult participants with IBD (moderate to severe Ulcerative Colitis (UC) or Crohn's Disease (CD)) as assessed by induction of clinical remission (UC) and endoscopic response (CD) at week 14. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn Disease, Colitis, Ulcerative
- What is being tested?
- TEV-48574
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 290 participants
- Where
- 164 sitesin 19 countries
- Study dates
- 30 Sep 2022to 12 Nov 2024
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) for ≥3 months
- The participant is able to communicate satisfactorily with the investigator and to participate in, and comply with, the requirements of the study
- The participant is able to understand the nature of the study and any potential hazards associated with participating in the study
- Women of non-childbearing potential who are either surgically (documented hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or congenitally sterile as assessed by a physician, or 1-year postmenopausal
- Male participants (including vasectomized) with women of childbearing potential (WOCBP) partners (whether pregnant or not) must use condoms after the first investigational medicinal product (IMP) administration and throughout the study or until 50 days after the last IMP dose, whichever is longer
- NOTE- Additional criteria apply, please contact the investigator for more information
Who cannot join
- The participant has any concomitant conditions or treatments that could interfere with study conduct, influence the interpretation of study observations/results, or put the participant at increased risk during the study as judged by the investigator and/or the clinical study physician
- Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic coliti
- Participant has colonic dysplasia or neoplasia, toxic megacolon, primary sclerosing cholangitis, known non-passable colonic stricture, presence of colonic or small bowel stoma, presence of non-passable colonic or small bowel obstruction or resection preventing the endoscopy procedure, or fulminant colitis
- Presence of active enteric infections (positive stool culture) or a history of serious infection (requiring parenteral antibiotic and/or hospitalization) within 4 weeks prior to the first screening visit
- Participant anticipates requiring major surgery during this study.
- A participant is Hepatitis B core antibody or surface antigen positive and/or Hepatitis C antibody positive with detectable ribonucleic acids, or positive human immunodeficiency virus types 1 or 2 at screening.
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- A history of an opportunistic infection (eg, cytomegalovirus retinitis, Pneumocystis carinii, or aspergillosis)
- A history of more than 2 herpes zoster episode in the last 5 years or multimetameric herpes zoster
- A history of or ongoing chronic or recurrent serious infectious disease (eg, infected indwelling prosthesis or osteomyelitis)
- The participant is currently pregnant or lactating or is planning to become pregnant or to lactate during the study or for at least 50 days after administration of the last dose of IMP in case of early termination. Any woman becoming pregnant during the study will be withdrawn from the study.
- Presence of a transplanted organ
- A history of malignancy within the last 5 years (exception: basal cell carcinoma or in situ carcinoma of the cervix if successful curative therapy occurred at least 12 months prior to screening) or curatively resected papillary thyroid cance
- Current or history (within 2 years) of serious psychiatric disease or alcohol or drug abuse
- Participants with incurable diseases, persons in nursing homes, and participants incapable of giving written informed consent
- NOTE- Additional criteria apply, please contact the investigator for more information
Trial locations and contacts
164 sites in 19 countries.
164 sites in 19 countries
Poland41 sites
Teva Investigational Site 53565
Bydgoszcz, 85-794
Teva Investigational Site 53542
Częstochowa, 42-202
Teva Investigational Site 53543
Elblag, 82-300
Teva Investigational Site 53544
Gdansk, 80-382
Teva Investigational Site 53545
Gdynia, 81-537
Teva Investigational Site 53571
Jelenia Góra, 58-500
Teva Investigational Site 53546
Katowice, 40-040
Teva Investigational Site 53547
Kłodzko, 57-300
Teva Investigational Site 53560
Krakow, 30-363
Teva Investigational Site 53548
Krakow, 31-156
Teva Investigational Site 53512
Krakow, 31-506
Teva Investigational Site 53511
Łęczna, 21-010
Teva Investigational Site 53515
Lodz, 90-752
Teva Investigational Site 53514
Lodz, 91-495
Teva Investigational Site 53518
Nowy Targ, 34-400
Teva Investigational Site 53559
Opole, 45-819
Teva Investigational Site 53572
Piotrkow Trybunalski, 97-300
Teva Investigational Site 53549
Poznan, 54-144
Teva Investigational Site 53563
Poznan, 54-144
Teva Investigational Site 53517
Poznan, 60-324
Teva Investigational Site 53516
Poznan, 60-529
Teva Investigational Site 53566
Poznan, 60-702
Teva Investigational Site 53513
Rzeszów, 35-326
Teva Investigational Site 53550
Sopot, 81-756
Teva Investigational Site 53551
Staszów, 28-200
Teva Investigational Site 53508
Szczecin, 71-434
Teva Investigational Site 53519
Szczecin, 71-685
Teva Investigational Site 53552
Tarnów, 33-100
Teva Investigational Site 53573
Tarnów, 33-100
Teva Investigational Site 53553
Torun, 87-100
Teva Investigational Site 53554
Wadowice, 34-100
Teva Investigational Site 53557
Warsaw, 00-189
Teva Investigational Site 53570
Warsaw, 02-672
Teva Investigational Site 53556
Warsaw, 02-786
Teva Investigational Site 53555
Warsaw, 04-501
Teva Investigational Site 53558
Wroclaw, 50-381
Teva Investigational Site 53510
Wroclaw, 52-416
Teva Investigational Site 53567
Wroclaw, 53-149
Teva Investigational Site 53562
Wroclaw, 53-611
Teva Investigational Site 53520
Wroclaw, 53-673
Teva Investigational Site 53509
Zamość, 22-400
United States36 sites
Teva Investigational Site 15360
Austin, Texas, 78748
Teva Investigational Site 15750
Beavercreek, Ohio, 45440
Teva Investigational Site 15370
Chapel Hill, North Carolina, 27514
Teva Investigational Site 15363
Columbia, Maryland, 21045
Teva Investigational Site 15573
Cordova, Tennessee, 38018
Teva Investigational Site 15371
Dallas, Texas, 75246
Teva Investigational Site 15569
Garland, Texas, 75044
Teva Investigational Site 15566
Glenview, Illinois, 60026
Teva Investigational Site 15557
Greenville, South Carolina, 29607
Teva Investigational Site 15567
Gurnee, Illinois, 60031
Teva Investigational Site 15559
Harlingen, Texas, 78550
Teva Investigational Site 15362
Iowa City, Iowa, 52242
Teva Investigational Site 15367
Kansas City, Kansas, 66160
Teva Investigational Site 15366
Katy, Texas, 77494
Teva Investigational Site 15357
Kissimmee, Florida, 34741
Teva Investigational Site 15369
Las Vegas, Nevada, 89128.
Teva Investigational Site 15358
Liberty, Missouri, 64068
Teva Investigational Site 15368
Louisville, Kentucky, 40202
Teva Investigational Site 15575
Louisville, Kentucky, 40218
Teva Investigational Site 15743
Lubbock, Texas, 79424
Teva Investigational Site 15563
Miami, Florida, 33032
Teva Investigational Site 15365
Miami, Florida, 33136
Teva Investigational Site 15748
Miami, Florida, 33176
Teva Investigational Site 15574
New Albany, Indiana, 47150
Teva Investigational Site 15558
North Massapequa, New York, 11758
Teva Investigational Site 15375
Orlando, Florida, 32803
Teva Investigational Site 15372
Pearland, Texas, 77584
Teva Investigational Site 15359
Pinellas Park, Florida, 33781
Teva Investigational Site 15364
Salt Lake City, Utah, 84124
Teva Investigational Site 15374
San Antonio, Texas, 78229
Teva Investigational Site 15556
San Diego, California, 92103
Teva Investigational Site 15747
San Diego, California, 92103
Teva Investigational Site 15565
Southlake, Texas, 76092
Teva Investigational Site 15373
St Louis, Missouri, 63110
Teva Investigational Site 15568
Sun City, Arizona, 85351
Teva Investigational Site 15361
Tyler, Texas, 75701
Ukraine10 sites
Teva Investigational Site 58327
Chernivtsi, 58002
Teva Investigational Site 58324
Ivano-Frankivsk, 76008
Teva Investigational Site 58329
Lviv, 79000
Teva Investigational Site 58325
Lviv, 79010
Teva Investigational Site 58332
Lviv, 79010
Teva Investigational Site 58328
Ternopil, 46002
Teva Investigational Site 58322
Uzhhorod, 88000
Teva Investigational Site 58323
Uzhhorod, 88000
Teva Investigational Site 58330
Vinnytsia, 21018
Teva Investigational Site 58331
Vinnytsia, 21018
Japan9 sites
Teva Investigational Site 84112
Fukuoka, 814-0180
Teva Investigational Site 84110
Kashiwa, 277-0871
Teva Investigational Site 84117
Minato, 108-8642
Teva Investigational Site 84115
Mitaka, 181-8611
Teva Investigational Site 84118
Nagoya, 457-8511
Teva Investigational Site 84113
Osaka, 530-0011
Teva Investigational Site 84114
Sakura, 285-8741
Teva Investigational Site 84116
Shinjuku, 169-0073
Teva Investigational Site 84111
Toyama, 930-8550
Germany8 sites
Teva Investigational Site 32796
Berlin, 10318
Teva Investigational Site 32872
Berlin, 12559
Teva Investigational Site 32873
Duisburg, 47055
Teva Investigational Site 32793
Kiel, 24105
Teva Investigational Site 32797
Leipzig, 04103
Teva Investigational Site 32795
Tübingen, 72076
Teva Investigational Site 32794
Ulm, 89081
Teva Investigational Site 32874
Wipperfürth, 51688
Slovakia8 sites
Teva Investigational Site 62098
Banská Bystrica, 975 17
Teva Investigational Site 62074
Bardejov, 085 01
Teva Investigational Site 62073
Bratislava, 811 09
Teva Investigational Site 62071
Košice, 040 13
Teva Investigational Site 62076
Prešov, 080 01
Teva Investigational Site 62097
Prešov, 080 01
Teva Investigational Site 62099
Rimavská Sobota, 979 01
Teva Investigational Site 62072
Šahy, 936 01
Italy7 sites
Teva Investigational Site 30304
Brescia, 25123
Teva Investigational Site 30285
Milan, 20132
Teva Investigational Site 30286
Milan, 20157
Teva Investigational Site 30284
Rozzano, 20089
Teva Investigational Site 30303
San Donato Milanese, 20097
Teva Investigational Site 30300
San Giovanni Rotondo, 71013
Teva Investigational Site 30301
Turin, 10128
Spain7 sites
Teva Investigational Site 31325
Alicante, 03010
Teva Investigational Site 31302
Córdoba, 14004
Teva Investigational Site 31293
Huelva, 21005
Teva Investigational Site 31301
Las Palmas de Gran Canaria, 35010
Teva Investigational Site 31318
Santiago de Compostela, 15702
Teva Investigational Site 31291
Seville, 41009
Teva Investigational Site 31292
Valencia, 46026
Georgia6 sites
Teva Investigational Site 81057
Tbilisi, 0102
Teva Investigational Site 81052
Tbilisi, 0119
Teva Investigational Site 81054
Tbilisi, 0160
Teva Investigational Site 81056
Tbilisi, 0178
Teva Investigational Site 81053
Tbilisi, 0180
Teva Investigational Site 81055
Tbilisi, 0180
Bulgaria5 sites
Teva Investigational Site 59243
Gorna Oryahovitsa, 5100
Teva Investigational Site 59198
Pleven, 5803
Teva Investigational Site 59197
Sofia, 1618
Teva Investigational Site 59199
Sofia, 1680
Teva Investigational Site 59196
Sofia, 1784
Czechia5 sites
Teva Investigational Site 54221
Brno, 615 00
Teva Investigational Site 54222
Klatovy, 339 01
Teva Investigational Site 54241
Prague, 140 00
Teva Investigational Site 54220
Slaný, 274 01
Teva Investigational Site 54242
Zábřeh, 78901
Hungary5 sites
Teva Investigational Site 51334
Budapest, 1085
Teva Investigational Site 51335
Budapest, H-1033
Teva Investigational Site 51336
Gyöngyös, 3200
Teva Investigational Site 51333
Székesfehérvár, H-8000
Teva Investigational Site 51338
Vác, H-2600
Israel5 sites
Teva Investigational Site 80179
Afula, 1834111
Teva Investigational Site 80191
Beersheba, 8410101
Teva Investigational Site 80184
Holon, 58100
Teva Investigational Site 80182
Kfar Saba, 4428164
Teva Investigational Site 80180
Rehovot, 7661041
France4 sites
Teva Investigational Site 35280
Caen, 14000
Teva Investigational Site 35295
Nantes, 44300
Teva Investigational Site 35277
Nice, 06200
Teva Investigational Site 35279
Saint-Priest-en-Jarez, 42270
Austria2 sites
Teva Investigational Site 33055
Innsbruck, 6020
Teva Investigational Site 33056
Vienna, 1090
Belgium2 sites
Teva Investigational Site 37134
Edegem, 2650
Teva Investigational Site 37133
Liège, 4000
Norway2 sites
Teva Investigational Site 41015
Lorenskog, 1478
Teva Investigational Site 41014
Tromsø, 9038
About this study
Official title: A 14 Week Phase 2b, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Efficacy, Safety and Tolerability of TEV-48574 in Adult Patients With Ulcerative Colitis or Crohn's Disease (RELIEVE UCCD)
The primary objective is to characterize the efficacy TEV-48574 in adult participants with IBD (moderate to severe Ulcerative Colitis (UC) or Crohn's Disease (CD)) as assessed by induction of clinical remission (UC) and endoscopic response (CD) at week 14.
Secondary objectives:
- To evaluate the efficacy of 2 different doses of TEV-48574 as assessed by multiple standard measures
- To evaluate the safety and tolerability of 2 different doses of TEV-48574
- To evaluate the immunogenicity of 2 different dioses of TEV-48574
The study will consist of a screening period of up to 6 weeks (42 days), a 14-week treatment period, and a 4-week follow-up period.
- Conditions
- Crohn Disease, Colitis, Ulcerative
- Being tested
- TEV-48574, Placebo
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEV-48574Drug
Also called duvakitug
Subcutaneous infusion
PlaceboDrug
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| TEV-48574, 450 mg (UC) | Experimental | Administered by subcutaneous infusion for participants with UC Receives: Drug: TEV-48574 |
| TEV-48574, 900 mg (UC) | Experimental | Administered by subcutaneous infusion for participants with UC Receives: Drug: TEV-48574 |
| TEV-48574, 1800 mg (UC) | Experimental | Administered by subcutaneous infusion for participants with UC. This arm was discontinued with Amend 03. Receives: Drug: TEV-48574 |
| TEV-48574, 450 mg (CD) | Experimental | Administered by subcutaneous infusion for participants with CD Receives: Drug: TEV-48574 |
| TEV-48574, 900 mg (CD) | Experimental | Administered by subcutaneous infusion for participants with CD Receives: Drug: TEV-48574 |
| TEV-48574, 1800 mg (CD) | Experimental | Administered by subcutaneous infusion for participants with CD. This arm was discontinued with Amend 03. Receives: Drug: TEV-48574 |
| Placebo UC | Placebo comparator | Matching Placebo Receives: Drug: Placebo |
| Placebo CD | Placebo comparator | Matching Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Moderate to Severe UC Who Showed Clinical Remission as Defined by the MMS
The MMS is a tool designed to measure disease activity for UC. It consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review. Each subscore was graded from 0 (normal) to 3 (severe). These individual subscores were summed up to give a total MMS ranging from 0 (normal or inactive disease) to 9 (severe disease), where higher scores indicated more severe disease activity. Clinical remission was defined as MMS ≤2 points with Mayo stool frequency subscore of 0 or 1, Mayo rectal bleeding subscore of 0, and centrally read endoscopic score of 0 or 1, where a score of 1 did not include "friability".
Measured: Week 14
Number of Participants With Moderate to Severe CD Who Showed an Endoscopic Response as Defined by the SES-CD
The SES-CD assessed the degree of inflammation. The SES-CD assesses the following 4 components: presence of ulcers, percentage of ulcerated surfaces, affected surface, and presence of strictures. Each of these components was scored on a scale of 0 (none/unaffected) to 3 (worst). In the SES-CD, each of these 4 components was assessed in the 5 segments: the rectum, sigmoid and left colon, transverse colon, right colon, and ileum. The SES-CD was the sum of the individual scores of each of the components across the 5 segments. The range of SES-CD scores was 0 (none) - 12 (severe) for each segment, and 0 (none) - 60 (severe) for the overall SES-CD score, with larger scores indicating greater degree of inflammation. Endoscopic response at Week 14 in participants with moderate to severe CD was defined as a reduction in SES-CD of at least 50% from baseline.
Measured: Baseline to Week 14
Secondary outcomes (14)
Number of Participants With Moderate to Severe UC With a Clinical Response as Defined by the MMS
The MMS is a tool designed to measure disease activity for UC. It consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review. Each subscore was graded from 0 (normal) to 3 (severe). These individual subscores were summed up to give a total MMS ranged from 0 (normal or inactive disease) to 9 (severe disease), where higher scores indicated more severe disease activity. Clinical response was defined as a decrease from baseline in the MMS of at least 2 points and at least a 30% reduction from baseline with either a decrease in rectal bleeding subscore of at least 1 or an absolute rectal bleeding subscore of ≤1.
Measured: Baseline to Week 14
Number of Participants With Moderate to Severe UC With Endoscopic Improvement as Defined by the Mayo Endoscopic Subscore (MES)
The endoscopic subscore evaluation for the MMS consisted of independent, blinded, central review of a high-resolution recorded video. The endoscopic subscore assessed disease activity from 0 (normal or inactive disease) to 3 (severe activity). Higher scores indicated more severe disease activity. Endoscopic improvement was defined as a MES of 0 or 1 at Week 14.
Measured: Week 14
Number of Participants With Moderate to Severe UC With Endoscopic Remission as Defined by the MES
The endoscopic subscore evaluation for the MMS consisted of independent, blinded, central review of a high-resolution recorded video. The endoscopic subscore assessed disease activity from 0 (normal or inactive disease) to 3 (severe activity). Higher scores indicated more severe disease activity. Endoscopic remission was defined as a MES of 0 at Week 14.
Measured: Week 14
Number of Participants With Moderate to Severe UC With a Clinical Response as Defined by 2-item Patient-reported Outcome (PRO2) Score
The PRO2-UC score was derived from 2 parameters from the MMS: stool frequency and rectal bleeding, recorded daily by the participant using a handheld electronic diary over each of the preceding 7 days. Each parameter ranged from 0 (normal) to 3 (severe) with each subscore representing an average over the preceding 7 days. The total score was the summation of the subscores and therefore ranged from 0 (normal or inactive disease) to 6 (severe activity), where higher scores indicated more severe disease activity. Clinical response was defined as decrease from baseline of at least 50% in PRO2 (stool frequency and rectal bleeding) at Week 14.
Measured: Baseline to Week 14
Number of Participants With Moderate to Severe UC With a Clinical Remission as Defined by PRO2 Score
The PRO2-UC score was derived from 2 parameters from the MMS: stool frequency and rectal bleeding, recorded daily by the participant using a handheld electronic diary over each of the preceding 7 days. Each parameter ranged from 0 (normal) to 3 (severe) with each subscore representing an average over the preceding 7 days. The total score was the summation of the subscores and therefore ranged from 0 (normal or inactive disease) to 6 (severe activity), where higher scores indicated more severe disease activity. Clinical remission was defined as score of stool frequency = 0 and rectal bleeding = 0 on the PRO2 scale at Week 14.
Measured: Week 14
Number of Participants With Moderate to Severe CD With an Endoscopic Response as Defined by the Modified Multiplier-Simple Endoscopic Score (MM-SES-CD)
The MM-SES-CD is an endoscopic scoring tool that considers each individual parameter's prognostic value for achieving endoscopic remission while on active therapy. The SES-CD assesses the following 4 components: presence of ulcers, percentage of ulcerated surfaces, affected surface, and presence of strictures. Each of these components was scored on a scale of 0 (none/unaffected) to 3 (worst). In the SES-CD, each of these 4 components was assessed in the 5 segments: the rectum, sigmoid and left colon, transverse colon, right colon, and ileum. The SES-CD was the sum of the individual scores of each of the components across the 5 segments. The range of SES-CD scores was 0 (none) - 12 (severe) for each segment, and 0 (none) - 60 (severe) for the overall SES-CD score, with higher scores indicating a greater degree of inflammation. Endoscopic response was defined as a decrease in MM-SES-CD of ≥50% from baseline at Week 14.
Measured: Baseline to Week 14
Number of Participants With Moderate to Severe CD With a Clinical Response as Defined by Crohn's Disease Activity Index (CDAI) Score
The CDAI score consisted of an adjusted composite sum of 8 parameters, including daily diary evaluation for severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight, and hematocrit. The subscores of abdominal pain (0 [no pain] to 3 [worst pain]), general well-being (0 [well] to 4 [terrible]), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score that ranged from 0 (none) to 600 (severe) with a higher score indicating a worse outcome. Clinical response was defined as a ≥100-point decrease in CDAI score from baseline.
Measured: Baseline to Weeks 4, 8, 12 and 14
Number of Participants With Moderate to Severe CD With a Clinical Remission as Defined by CDAI Score
The CDAI score consisted of an adjusted composite sum of 8 parameters, including daily diary evaluation for severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight, and hematocrit. The subscores of abdominal pain (0 [no pain] to 3 [worst pain]), general well-being (0 [well] to 4 [terrible]), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score that ranged from 0 (none) to 600 (severe) with a higher score indicating a worse outcome. Clinical remission was defined as a CDAI score <150 at Week 14.
Measured: Week 14
Number of Participants With Moderate to Severe CD With a Clinical Response as Defined by PRO2-CD Score
The PRO2-CD score was the sum of the daily stool frequency subscore (0 [normal] to 3 [severe]) and abdominal pain subscore (0 [no pain] to 3 [worst pain]) from the CDAI. Total PRO2-CD score ranged from 0 (normal) - 6 (severe), with higher scores indicating more severe disease. These were recorded daily by the participant using a handheld electronic diary over each of the preceding 7 days. Clinical response was defined as a decrease from baseline of at least 50% in PRO2-CD (abdominal pain and stool frequency) at Week 14.
Measured: Baseline to Week 14
Number of Participants With Moderate to Severe CD With a Clinical Remission as Defined by PRO2-CD Score
The PRO2-CD score was the sum of the daily stool frequency subscore (0 [normal] to 3 [severe]) and abdominal pain subscore (0 [no pain] to 3 [worst pain]) from the CDAI. Total PRO2-CD score ranged from 0 (normal) - 6 (severe), with higher scores indicating more severe disease. These were recorded daily by the participant using a handheld electronic diary over each of the preceding 7 days. Clinical remission was defined as abdominal pain ≤1 and stool frequency ≤3 on the PRO2-CD scale at Week 14
Measured: Week 14
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were considered TEAEs if onset occurred on or after the first dose date. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Measured: Baseline (Day 1) up to Week 18
Number of Participants Who Stopped Taking the Investigational Medicinal Product (IMP) Due to AEs
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Measured: Baseline (Day 1) up to Week 18
Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs)
Treatment-emergent ADA positive: - the participant had a positive ADA sample (after first dose of study drug) but not at baseline (prior to first dose of study drug), or - the participant had a positive ADA sample at baseline (prior to first dose of study drug) and at the visit (after first dose of study drug), with at least a 4-fold increase in titer level.
Measured: Weeks 2, 4, 8, 14, and 18
Number of ADA Positive Participants With the Presence of Neutralizing ADA
Treatment-emergent ADA positive: - the participant had a positive ADA sample (after first dose of study drug) but not at baseline (prior to first dose of study drug), or - the participant had a positive ADA sample at baseline (prior to first dose of study drug) and at the visit (after first dose of study drug), with at least a 4-fold increase in titer level.
Measured: Weeks 2, 4, 8, 14, and 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start30 Sep 2022
- Primary completion12 Nov 2024
- Study completion12 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Teva Medical Expert, MD, Study director, Teva Branded Pharmaceutical Products R&D, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499130
- Sponsor's protocol ID
- TV48574-IMM-20036
- Other IDs
- 2021-006881-19, 2024-511089-36-00
- Acronym
- RELIEVE UCCD
- Status last verified
- Mar 2026
- First submitted
- 11 Aug 2022
- Last updated
- 27 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.
Publications
Reinisch W, Stepek D, Kempinski R, Danese S, Sands BE, Ratiu-Duma B, Singh R, Levine P, Barkay H, Gross N, Abrams K, Jairath V. Efficacy and safety of duvakitug in patients with ulcerative colitis (RELIEVE UCCD): a phase 2b, randomised, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2026 Sep;11(9):775-785. doi: 10.1016/S2468-1253(26)00120-2. Epub 2026 Jul 16.
PubMed 42462750Jairath V, Kierkus J, Duvall GA, Danese S, Sands BE, Ratiu-Duma B, Singh R, Levine P, Barkay H, Gross N, Abrams K, Reinisch W. Efficacy and safety of duvakitug in patients with Crohn's disease (RELIEVE UCCD): a phase 2b, randomised, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2026 Sep;11(9):786-796. doi: 10.1016/S2468-1253(26)00119-6. Epub 2026 Jul 16.
PubMed 42462749