DermatitisPhase 2NCT03706040
A Study to Evaluate Risankizumab in Adults and Adolescents With Moderate to Severe Atopic Dermatitis
A Phase 2 study testing Risankizumab in people with Dermatitis, run by AbbVie at 65 sites in 5 countries.
Trial summary
The purpose of this study is to assess the safety and efficacy of risankizumab for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Dermatitis
- What is being tested?
- Risankizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 172 participants
- Where
- 65 sitesin 5 countries
- Study dates
- 27 Dec 2018to 26 Apr 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- adults who are ≥ 18 years old and, where locally permissible and approved, adolescent subjects who are at least 12 years old
- a diagnosis of atopic dermatitis (AD) with onset of symptoms at least 2 years prior to Baseline and subject meets Hanifin and Rajka criteria
- moderate to severe AD at the Baseline Visit
- history of inadequate response to previous topical corticosteroid and/or topical calcineurin inhibitor treatments or a medical inability to receive these treatments
Who cannot join
- prior exposure to any biologic immunomodulatory agent or Janus kinase (JAK) inhibitor
- concurrent treatment with systemic therapy for AD (biologic or non-biologic) or topical and/or phototherapy treatments
Trial locations and contacts
65 sites in 5 countries.
65 sites in 5 countries
United States39 sites
Cosmetic Dermatology of Orange County /ID# 205801
Anaheim, California, 92807-4780
Arlington Research Center, Inc /ID# 215899
Arlington, Texas, 76011
MetroDerm ACC Research /ID# 205958
Atlanta, Georgia, 30342-1418
Oakland Hills Dermatology /ID# 217453
Auburn Hills, Michigan, 48326-4600
Tekton Research, Inc. /ID# 211558
Austin, Texas, 78745
Duplicate_Great Lakes Research, Inc. /ID# 206447
Bay City, Michigan, 48602
UAB Department of Dermatology /ID# 211561
Birmingham, Alabama, 35233
Colorado Center for Dermatology, PLLC /ID# 216260
Centennial, Colorado, 80111-1724
Darst Dermatology /ID# 215100
Charlotte, North Carolina, 28277
University Dermatology and Vein Clinic, LLC /ID# 210702
Darien, Illinois, 60561
Dermatologic SurgiCenter /ID# 208972
Drexel Hill, Pennsylvania, 19026-1101
Psoriasis Treatment Center of Central New Jersey /ID# 203203
East Windsor, New Jersey, 08520
Center for Dermatology Clinical Research /ID# 204950
Fremont, California, 94538
Rivergate Dermatology & Skin Care Center /ID# 203372
Goodlettsville, Tennessee, 37072-2301
Dermdox Dermatology Centers, PC /ID# 212259
Hazleton, Pennsylvania, 18201
Center for Clinical Studies - Houston (Binz) /ID# 203383
Houston, Texas, 77004-8097
RI SkinDoc /ID# 203417
Johnston, Rhode Island, 02910-4423
Skin Care Physicians of Georgia /ID# 213188
Macon, Georgia, 31217
Dermatologists of Southwest Ohio, Inc /ID# 215104
Mason, Ohio, 45040-4520
Tulane University /ID# 203214
New Orleans, Louisiana, 70112-2699
Virginia Dermatology & Skin Cancer Center /ID# 210154
Norfolk, Virginia, 23502-2233
Unity Clinical Research /ID# 217461
Oklahoma City, Oklahoma, 73118
Park Avenue Dermatology, PA /ID# 203378
Orange Park, Florida, 32073
University of Pittsburgh MC /ID# 203296
Pittsburgh, Pennsylvania, 15260
The Indiana Clinical Trials Center /ID# 211618
Plainfield, Indiana, 46168
Derm Assoc of Plymouth Meeting /ID# 208925
Plymouth Meeting, Pennsylvania, 19462
Oregon Derm & Res. Ctr /ID# 202880
Portland, Oregon, 97210
Health Concepts /ID# 203205
Rapid City, South Dakota, 57702
Skin Cancer and Dermatology Institute (SCDI) /ID# 213041
Reno, Nevada, 89052
Dominion Medical Associates /ID# 212986
Richmond, Virginia, 23219
DermAssociates /ID# 206189
Rockville, Maryland, 20850
Integrative Skin Science and Research /ID# 212486
Sacramento, California, 95815-4500
Cosmetic Laser Dermatology /ID# 210560
San Diego, California, 92121-2119
Therapeutics Clinical Research /ID# 203422
San Diego, California, 92123
Cognitive Clinical Trials /ID# 208895
Scottsdale, Arizona, 85258-4446
Acclaim Dermatology /ID# 213026
Sugar Land, Texas, 77479-2645
The Vancouver Clinic, INC. PS /ID# 202930
Vancouver, Washington, 98664
Grekin Skin Institute /ID# 210485
Warren, Michigan, 48088
Omega Medical Research /ID# 216022
Warwick, Rhode Island, 02886
Japan10 sites
Hamamatsu University Hospital /ID# 203270
Hamamatsu, Shizuoka, 431-3192
Teikyo University Hospital /ID# 202884
Itabashi-ku, Tokyo, 173-8606
Nippon Medical School Musashi Kosugi Hospital /ID# 213961
Kawasaki-shi, Kanagawa, 211-8533
Kurume University Hospital /ID# 203139
Kurume-shi, Fukuoka, 830-0011
Nagaoka Red Cross Hospital /ID# 214140
Nagaoka-shi, Niigata, 940-2085
Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 213667
Nagoya, Aichi-ken, 455-8530
University of the Ryukyus Hospital /ID# 203974
Nakagami-gun, Okinawa, 903-0215
Osaka City University Hospital /ID# 203410
Osaka, Osaka, 545-8586
Tokyo Medical University Hospital /ID# 203647
Shinjuku-ku, Tokyo, 160-0023
Tokyo Medical University Hospital /ID# 204101
Shinjuku-ku, Tokyo, 160-0023
Canada7 sites
Kirk Barber Research, CA /ID# 201046
Calgary, Alberta, T2G 1B1
Beacon Dermatology Inc /ID# 213003
Calgary, Alberta, T3E 0B2
University of Alberta Hospital - Division of Hematology /ID# 213008
Edmonton, Alberta, T6G 2B7
Medicor Research Inc /ID# 211274
Greater Sudbury, Ontario, P3A 1W8
Dr. Wei Jing Loo Medicine Prof /ID# 208849
London, Ontario, N6H 5L5
Lynderm Research Inc. /ID# 201050
Markham, Ontario, L3P 1X2
Dre Angelique Gagne-Henley M.D. inc. /ID# 208189
Saint-Jérôme, Quebec, J7Z 7E2
Australia6 sites
Skin Health Institute Inc /ID# 204779
Carlton, Victoria, 3053
Fremantle Dermatology /ID# 204784
Fremantle, Western Australia, 6160
North Eastern Health Specialists /ID# 204785
Hectorville, South Australia, 5073
St George Hospital /ID# 204780
Kogarah, New South Wales, 2217
Woden Dermatology /ID# 204778
Phillip, Australian Capital Territory, 2606
Veracity Clinical Research /ID# 204786
Woolloongabba, Queensland, 4102
Puerto Rico3 sites
Dr. Samuel Sanchez PSC /ID# 213117
Caguas, 00727
Cruz-Santana, Carolina, PR /ID# 213229
Carolina, 00985
Clinical Research Puerto Rico /ID# 213118
San Juan, 00909
About this study
Official title: A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Risankizumab in Adult and Adolescent Subjects With Moderate to Severe Atopic Dermatitis
The purpose of this study is to assess the safety and efficacy of risankizumab for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents.
Read the detailed description
This study includes a screening period of up to 35 days, a 16-week double-blind treatment period (Period A), and a 36-week double-blind treatment period (Period B).
Participants who meet eligibility criteria will be randomized at Baseline in a 2:2:1 ratio to one of 3 treatment groups: (1) risankizumab 150 mg, (2) risankizumab 300 mg, or (3) matching placebo. Randomization will be stratified by Baseline disease severity (Validated Investigator Global Assessment scale for Atopic Dermatitis [vIGA-AD] score of moderate [3] versus severe [4]) and geographic region (Japan versus rest of world).
At Week 16, participants in the placebo group will be re-randomized in a 1:1 ratio to receive either risankizumab 150 mg or 300 mg for the remainder of the study. Participants originally randomized to the risankizumab 150 mg or 300 mg arms will stay on their previously-assigned treatment through the end of the study.
- Conditions
- Dermatitis
- Being tested
- Placebo, Risankizumab
- Keywords
- Atopic dermatitis, Atopic dermatitis (atopic eczema)
- Medical subject headings
- Dermatitis, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
subcutaneous (SC) injection
RisankizumabBiological
Also called ABBV-066, BI 655066
subcutaneous (SC) injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants randomized to receive placebo for 16 weeks in Period A followed by either risankizumab 150 mg or risankizumab 300 mg for 36 weeks in Period B. Receives: Biological: Placebo; Biological: Risankizumab |
| Risankizumab 150 mg | Experimental | Participants randomized to receive risankizumab 150 mg for 16 weeks in Period A followed by risankizumab 150 mg for 36 weeks in Period B. Receives: Biological: Risankizumab |
| Risankizumab 300 mg | Experimental | Participants randomized to receive risankizumab 300 mg for 16 weeks in Period A followed by risankizumab 300 mg for 36 weeks in Period B. Receives: Biological: Risankizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving At Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI 75) at Week 16
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
Measured: Baseline and Week 16
Secondary outcomes (31)
Percentage of Participants Who Achieved a vIGA-AD Score of "0" or "1" With a Reduction From Baseline of ≥ 2 Points at Week 16
Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) was used to assess the severity of AD based on lesion appearance on the following scale:
- 0 - Clear: No signs of AD;
- 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification;
- 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting;
- 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, possible oozing or crusting;
- 4 - Severe: Marked erythema, induration/papulation and/or lichenification; possible oozing or crusting.
Measured: Baseline and Week 16
Percentage of Participants Who Achieved a Reduction of ≥ 4 Points in Worst Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16
Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
Measured: Baseline and Week 16
Percent Change From Baseline in EASI Score at Week 16
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement.
Measured: Baseline and Week 16
Percent Change From Baseline in EASI Score at Week 28 and Week 52
EASI is used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected and the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling), scratching, and lichenification (lined skin, prurigo nodules).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement.
LS means were calculated from an analysis of covariance (ANCOVA) model with Baseline, treatment and vIGA-AD categories in the model.
Measured: Baseline and Weeks 28 and 52
Percentage of Participants Who Achieved an EASI 75 Response at Week 28 and Week 52
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
Measured: Baseline and Weeks 28 and 52
Percentage of Participants Who Achieved an EASI 50 Response at Week 16
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
EASI 50 response is defined as at least a 50% reduction (improvement) from Baseline in EASI score.
Measured: Baseline and Week 16
Percentage of Participants Who Achieved an EASI 50 Response at Week 28 and Week 52
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
An EASI 50 response is defined as at least a 50% reduction (improvement) from Baseline in EASI score.
Measured: Baseline and Weeks 28 and 52
Percentage of Participants Who Achieved an EASI 90 Response at Week 16
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
An EASI 90 response is defined as at least a 90% reduction (improvement) from Baseline in EASI score.
Measured: Baseline, Week 16
Percentage of Participants Who Achieved an EASI 90 Response at Week 28 and Week 52
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
An EASI 90 response is defined as at least a 90% reduction (improvement) from Baseline in EASI score.
Measured: Baseline and Weeks 28 and 52
Percentage of Participants Who Achieved a vIGA-AD Score of "0" or "1" With a Reduction From Baseline of ≥ 2 Points at Week 28 and Week 52
Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) was used to assess the severity of AD based on lesion appearance on the following scale:
- 0 - Clear: No signs of AD;
- 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification;
- 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting;
- 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, possible oozing or crusting;
- 4 - Severe: Marked erythema, induration/papulation and/or lichenification; possible oozing or crusting.
Measured: Baseline and Weeks 28 and 52
Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Atopic Dermatitis at Week 16
Body surface area (BSA) affected by atopic dermatitis was assessed by the physician and is expressed as a percentage of the total BSA. For purposes of the estimation, the total surface of the participant's palm plus five digits was assumed to be approximately equivalent to 1% BSA. A negative change from Baseline indicates improvement.
Measured: Baseline and Week 16
Change From Baseline in Percentage of BSA Affected by Atopic Dermatitis at Weeks 28 and 52
Body surface area (BSA) affected by atopic dermatitis was assessed by the physician and is expressed as a percentage of the total BSA. For purposes of the estimation, the total surface of the participant's palm plus five digits was assumed to be approximately equivalent to 1% BSA. A negative change from Baseline indicates improvement.
LS means and standard errors were calculated from ANCOVA with Baseline, treatment and stratum (Baseline vIGA-AD categories) in the model.
Measured: Baseline and Weeks 28 and 52
Percentage of Participants Who Achieved a 50% Improvement in SCORing Atopic Dermatitis (SCORAD) Score (SCORAD 50) at Week 16
SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst).
Measured: Baseline, Week 16
Percentage of Participants Who Achieved a SCORAD 50 Response at Week 28 and Week 52
SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst).
Measured: Baseline and Weeks 28 and 52
Percentage of Participants Who Achieved a SCORAD 75 Response at Week 16
SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst).
A SCORAD 75 response is defined as at least a 75% reduction (improvement) from Baseline in SCORAD score.
Measured: Baseline and Week 16
Percentage of Participants Who Achieved a SCORAD 75 Response at Week 28 and Week 52
SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst).
A SCORAD 75 response is defined as at least a 75% reduction (improvement) from Baseline in SCORAD score.
Measured: Baseline and Weeks 28 and 52
Percentage of Participants Who Achieved a SCORAD 90 Response at Week 16
SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst).
A SCORAD 90 response is defined as at least a 90% reduction (improvement) from Baseline in SCORAD score.
Measured: Baseline and Week 16
Percentage of Participants Who Achieved a SCORAD 90 Response at Week 28 and Week 52
SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst).
A SCORAD 90 response is defined as at least a 90% reduction (improvement) from Baseline in SCORAD score.
Measured: Baseline and Weeks 28 and 52
Percentage of Participants Who Achieved a Dermatology Life Quality Index (DLQI) Score of "0" or "1" at Week 16
The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).
Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A score of 0 or 1 means that the disease has no effect at all.
Measured: Week 16
Percentage of Participants Who Achieved a DLQI Score of "0" or "1" at Week 28 and Week 52
The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).
Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A score of 0 or 1 means that the disease has no effect at all.
Measured: Weeks 28 and 52
Percentage of Participants Who Achieved a Children's Dermatology Life Quality Index (CDLQI) Score of "0" or "1" at Week 16
The CDLQI is a 10-item, validated questionnaire used to assess the impact of AD disease symptoms and treatment on QoL. The CDLQI has been validated for use in individuals 4-16 years old. It consists of 10 questions assessing impact of skin diseases on different aspects of a patient's QoL over the prior week. The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item is scored on a 4-point scale (0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much). Item scores (0 to 3) are added to provide a total score range of 0 to 30; higher scores indicate greater impairment of QoL. A score of 0 or 1 means that the disease has no effect at all.
In this study, the CDLQI was administered to participants who were < 16 years old at Baseline.
Measured: Week 16
Percentage of Participants Who Achieved a CDLQI Score of "0" or "1" at Week 28 and Week 52
The CDLQI is a 10-item, validated questionnaire used to assess the impact of AD disease symptoms and treatment on QoL. The CDLQI has been validated for use in individuals 4-16 years old. It consists of 10 questions assessing impact of skin diseases on different aspects of a patient's QoL over the prior week. The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item is scored on a 4-point scale (0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much). Item scores (0 to 3) are added to provide a total score range of 0 to 30; higher scores indicate greater impairment of QoL. A score of 0 or 1 means that the disease has no effect at all.
In this study, the CDLQI was administered to participants who were < 16 years old at Baseline.
Measured: Weeks 28 and 52
Percentage of Participants Who Achieved a Reduction in DLQI of ≥ 4 Points From Baseline at Week 16 Among Those With a DLQI ≥ 4 at Baseline
The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).
Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL.
A change in DLQI score of at least 4 points is considered the minimum clinically important difference (MCID).
Measured: Baseline and Week 16
Percentage of Participants Who Achieved a Reduction in DLQI of ≥ 4 Points From Baseline at Week 28 and Week 52 Among Those With a DLQI ≥ 4 at Baseline
The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).
Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL.
A change in DLQI score of at least 4 points is considered the minimum clinically important difference (MCID).
Measured: Baseline and Weeks 28 and 52
Change From Baseline in DLQI Score at Week 16
The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).
Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A negative change from Baseline indicates improvement.
Measured: Baseline and Week 16
Change From Baseline in DLQI Score at Week 28 and Week 52
The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).
Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A negative change from Baseline indicates improvement.
LS means and standard errors were calculated from an ANCOVA model with Baseline, treatment and stratum (Baseline vIGA-AD categories) in the model.
Measured: Baseline and Weeks 28 and 52
Change From Baseline in CDLQI Score at Week 16
The CDLQI is a 10-item, validated questionnaire used to assess the impact of AD disease symptoms and treatment on QoL. The CDLQI has been validated for use in individuals 4-16 years old. It consists of 10 questions assessing impact of skin diseases on different aspects of a patient's QoL over the prior week. The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item is scored on a 4-point scale (0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much). Item scores (0 to 3) are added to provide a total score range of 0 to 30; higher scores indicate greater impairment of QoL. A negative change from Baseline indicates improvement.
In this study, the CDLQI was administered to participants who were < 16 years old at the Baseline visit.
Measured: Baseline and Week 16
Change From Baseline in CDLQI Score at Week 28 and Week 52
The CDLQI is a 10-item, validated questionnaire used to assess the impact of AD disease symptoms and treatment on QoL. The CDLQI has been validated for use in individuals 4-16 years old. It consists of 10 questions assessing impact of skin diseases on different aspects of a patient's QoL over the prior week. The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item is scored on a 4-point scale (0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much). Item scores (0 to 3) are added to provide a total score range of 0 to 30; higher scores indicate greater impairment of QoL. A negative change from Baseline indicates improvement.
In this study, the CDLQI was administered to participants who were < 16 years old at the Baseline visit.
LS means were calculated from ANCOVA with Baseline and treatment in the model.
Measured: Baseline and Weeks 28 and 52
Change From Baseline in Worst Pruritus Numerical Rating Scale at Week 16
Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Change from Baseline was calculated from a rolling weekly average. A negative change from Baseline indicates improvement.
Measured: Baseline and Week 16
Change From Baseline in Worst Pruritus NRS Score at Week 28 and Week 52
Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Change from Baseline was calculated from a rolling weekly average. A negative change from Baseline indicates improvement.
LS means and standard errors were calculated from an ANCOVA with Baseline, treatment and stratum (Baseline vIGA-AD categories) in the model.
Measured: Baseline and Weeks 28 and 52
Percentage of Participants Who Achieved a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS Score at Week 28 and Week 52
Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
Measured: Baseline and Weeks 28 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start27 Dec 2018
- Primary completion28 Oct 2020
- Study completion26 Apr 2021
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 (1)Papers the sponsor has linked to this study.
- Other trials for DermatitisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706040
- Sponsor's protocol ID
- M16-813
- Other IDs
- 2021-002203-34
- Status last verified
- Oct 2021
- First submitted
- 11 Oct 2018
- Last updated
- 18 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Publications
Tyring SK, Rich P, Tada Y, Beeck S, Messina I, Liu J, Huang X, Shumack S. Risankizumab in Patients with Moderate-to-Severe Atopic Dermatitis: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study. Dermatol Ther (Heidelb). 2023 Feb;13(2):595-608. doi: 10.1007/s13555-022-00876-x. Epub 2023 Jan 2.
PubMed 36588137
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Risankizumab in Adult and Adolescent Subjects With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03706040
- Acronym / sponsor ID
- M16-813
- Conditions
- Dermatitis
- Keywords
- Atopic dermatitis, Atopic dermatitis (atopic eczema)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 27 Dec 2018 (actual)
- Primary completion
- 28 Oct 2020 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 15 Oct 2018 (actual)
- Results
- Posted 18 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and efficacy of risankizumab for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents.
Detailed description
This study includes a screening period of up to 35 days, a 16-week double-blind treatment period (Period A), and a 36-week double-blind treatment period (Period B).
Participants who meet eligibility criteria will be randomized at Baseline in a 2:2:1 ratio to one of 3 treatment groups: (1) risankizumab 150 mg, (2) risankizumab 300 mg, or (3) matching placebo. Randomization will be stratified by Baseline disease severity (Validated Investigator Global Assessment scale for Atopic Dermatitis [vIGA-AD] score of moderate [3] versus severe [4]) and geographic region (Japan versus rest of world).
At Week 16, participants in the placebo group will be re-randomized in a 1:1 ratio to receive either risankizumab 150 mg or 300 mg for the remainder of the study. Participants originally randomized to the risankizumab 150 mg or 300 mg arms will stay on their previously-assigned treatment through the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: Placebo, Biological: RisankizumabParticipants randomized to receive placebo for 16 weeks in Period A followed by either risankizumab 150 mg or risankizumab 300 mg for 36 weeks in Period B. |
| Risankizumab 150 mg | Experimental | Biological: RisankizumabParticipants randomized to receive risankizumab 150 mg for 16 weeks in Period A followed by risankizumab 150 mg for 36 weeks in Period B. |
| Risankizumab 300 mg | Experimental | Biological: RisankizumabParticipants randomized to receive risankizumab 300 mg for 16 weeks in Period A followed by risankizumab 300 mg for 36 weeks in Period B. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- adults who are ≥ 18 years old and, where locally permissible and approved, adolescent subjects who are at least 12 years old
- a diagnosis of atopic dermatitis (AD) with onset of symptoms at least 2 years prior to Baseline and subject meets Hanifin and Rajka criteria
- moderate to severe AD at the Baseline Visit
- history of inadequate response to previous topical corticosteroid and/or topical calcineurin inhibitor treatments or a medical inability to receive these treatments
Key exclusion criteria (2 listed)
- prior exposure to any biologic immunomodulatory agent or Janus kinase (JAK) inhibitor
- concurrent treatment with systemic therapy for AD (biologic or non-biologic) or topical and/or phototherapy treatments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebosubcutaneous (SC) injection | Biological | Placebo |
| RisankizumabAlso: ABBV-066, BI 655066subcutaneous (SC) injection | Biological | Placebo, Risankizumab 150 mg, Risankizumab 300 mg |
Primary outcome
Percentage of Participants Achieving At Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI 75) at Week 16
Time frame: Baseline and Week 16
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
31 secondary outcomes
Percentage of Participants Who Achieved a vIGA-AD Score of "0" or "1" With a Reduction From Baseline of ≥ 2 Points at Week 16
Time frame: Baseline and Week 16
Percentage of Participants Who Achieved a Reduction of ≥ 4 Points in Worst Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16
Time frame: Baseline and Week 16
Percent Change From Baseline in EASI Score at Week 16
Time frame: Baseline and Week 16
Percent Change From Baseline in EASI Score at Week 28 and Week 52
Time frame: Baseline and Weeks 28 and 52
Percentage of Participants Who Achieved an EASI 75 Response at Week 28 and Week 52
Time frame: Baseline and Weeks 28 and 52
Percentage of Participants Who Achieved an EASI 50 Response at Week 16
Time frame: Baseline and Week 16
Percentage of Participants Who Achieved an EASI 50 Response at Week 28 and Week 52
Time frame: Baseline and Weeks 28 and 52
Percentage of Participants Who Achieved an EASI 90 Response at Week 16
Time frame: Baseline, Week 16
Percentage of Participants Who Achieved an EASI 90 Response at Week 28 and Week 52
Time frame: Baseline and Weeks 28 and 52
Percentage of Participants Who Achieved a vIGA-AD Score of "0" or "1" With a Reduction From Baseline of ≥ 2 Points at Week 28 and Week 52
Time frame: Baseline and Weeks 28 and 52
Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Atopic Dermatitis at Week 16
Time frame: Baseline and Week 16
Change From Baseline in Percentage of BSA Affected by Atopic Dermatitis at Weeks 28 and 52
Time frame: Baseline and Weeks 28 and 52
Percentage of Participants Who Achieved a 50% Improvement in SCORing Atopic Dermatitis (SCORAD) Score (SCORAD 50) at Week 16
Time frame: Baseline, Week 16
Percentage of Participants Who Achieved a SCORAD 50 Response at Week 28 and Week 52
Time frame: Baseline and Weeks 28 and 52
Percentage of Participants Who Achieved a SCORAD 75 Response at Week 16
Time frame: Baseline and Week 16
Percentage of Participants Who Achieved a SCORAD 75 Response at Week 28 and Week 52
Time frame: Baseline and Weeks 28 and 52
Percentage of Participants Who Achieved a SCORAD 90 Response at Week 16
Time frame: Baseline and Week 16
Percentage of Participants Who Achieved a SCORAD 90 Response at Week 28 and Week 52
Time frame: Baseline and Weeks 28 and 52
Percentage of Participants Who Achieved a Dermatology Life Quality Index (DLQI) Score of "0" or "1" at Week 16
Time frame: Week 16
Percentage of Participants Who Achieved a DLQI Score of "0" or "1" at Week 28 and Week 52
Time frame: Weeks 28 and 52
Percentage of Participants Who Achieved a Children's Dermatology Life Quality Index (CDLQI) Score of "0" or "1" at Week 16
Time frame: Week 16
Percentage of Participants Who Achieved a CDLQI Score of "0" or "1" at Week 28 and Week 52
Time frame: Weeks 28 and 52
Percentage of Participants Who Achieved a Reduction in DLQI of ≥ 4 Points From Baseline at Week 16 Among Those With a DLQI ≥ 4 at Baseline
Time frame: Baseline and Week 16
Percentage of Participants Who Achieved a Reduction in DLQI of ≥ 4 Points From Baseline at Week 28 and Week 52 Among Those With a DLQI ≥ 4 at Baseline
Time frame: Baseline and Weeks 28 and 52
Change From Baseline in DLQI Score at Week 16
Time frame: Baseline and Week 16
Change From Baseline in DLQI Score at Week 28 and Week 52
Time frame: Baseline and Weeks 28 and 52
Change From Baseline in CDLQI Score at Week 16
Time frame: Baseline and Week 16
Change From Baseline in CDLQI Score at Week 28 and Week 52
Time frame: Baseline and Weeks 28 and 52
Change From Baseline in Worst Pruritus Numerical Rating Scale at Week 16
Time frame: Baseline and Week 16
Change From Baseline in Worst Pruritus NRS Score at Week 28 and Week 52
Time frame: Baseline and Weeks 28 and 52
Percentage of Participants Who Achieved a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS Score at Week 28 and Week 52
Time frame: Baseline and Weeks 28 and 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36588137Tyring SK, Rich P, Tada Y, Beeck S, Messina I, Liu J, Huang X, Shumack S. Risankizumab in Patients with Moderate-to-Severe Atopic Dermatitis: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study. Dermatol Ther (Heidelb). 2023 Feb;13(2):595-608. doi: 10.1007/s13555-022-00876-x. Epub 2023 Jan 2.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
65 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Risankizumab in people with Dermatitis, run by AbbVie at 65 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in United States, Japan, Canada, Australia, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving At Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI 75) at Week 16 (time frame: Baseline and Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03706040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2021.