Trial · NCT05216224
ATI-450 vs Placebo in Participants With Moderate to Severe Hidradenitis Suppurativa (HS)
NCT05216224, Phase 2, Completed, Aclaris Therapeutics, Inc.; results first posted 2026-01-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. ATI-450 vs Placebo in Participants With Moderate to Severe Hidradenitis Suppurativa (HS). Trials, record NCT05216224. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05216224
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ATI-450 vs Placebo in Participants With Moderate to Severe Hidradenitis Suppurativa (HS)
- NCT number
- NCT05216224
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 95 participants, actual
- Lead sponsor
- Aclaris Therapeutics, Inc.
- Conditions
- Hidradenitis Suppurativa
- Interventions
- ATI-450, Placebo oral tablet
- First posted
- 2022-01-31
- Last updated
- 2026-01-07
- Results first posted
- 2026-01-07
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 12 | Baseline, Week 12 | AN count was the sum of number of abscess and inflammatory nodules across anatomical regions. The least square (LS) mean change from baseline in the count at Week 12 was estimated from the Mixed Model Repeated Measures (MMRM) model. |
| Secondary | Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 12 | Week 12 | HiSCR50 Achiever was defined as a participant having a ≥50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase in the number of abscesses, and no increase in the number of draining fistula counts from baseline. A participant was considered an achiever only if all 3 criteria mentioned above were fulfilled. Model-based estimates and 90% confidence intervals (CIs) were produced. Firth's penalized likelihood logistic regression model with fixed effects for treatment and baseline count of inflammatory abscesses and nodules was used. |
| Secondary | Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS-4) at Week 12 | Baseline, Week 12 | The IHS-4 is a validated tool used to access the HS severity and is calculated based on the clinical signs of HS: inflammatory nodules, abscesses and draining tunnels (fistulas and sinuses). The IHS-4 score = (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + (number of draining tunnels \[fistulas/sinuses\] multiplied by 4). Mild HS is a score of 3 or less, moderate HS is a score of 4-10, and severe HS is a score of 11 or higher. A decrease in score means less severity. |
| Secondary | Percentage of Participants Achieving NRS30 | Week 12 | NRS30 Achiever was defined as participants achieving at least a 30% reduction from baseline in Patient's Global Assessment of Skin Pain (PGA-SP) and at least 1 unit reduction from baseline in PGA-SP at Week 12 among participants with baseline PGA-SP ≥3. Model-based estimates and 90% CIs were produced. Firth's penalized likelihood logistic regression model with fixed effects for treatment and baseline PGA-SP was used. |
| Secondary | Change From Baseline in Hidradenitis Suppurativa-Physician Global Assessment (HSPGA) at Week 12 | Baseline, Week 12 | In the HS-PGA scale, the Investigators rated the counts of nodules (inflammatory and non-inflammatory) abscesses and fistulas (both draining and nondraining) and assigned a participant to 1 of 6 categories ranging from clear (0) to very severe (5). A decrease in score means a better outcome. |
| Secondary | Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 12 | Baseline, Week 12 | The DLQI is a 10-item validated questionnaire used to assess the impact of HS disease symptoms and treatment on quality of life (QoL). It consists of questions including a single "yes/no" question and questions with possible responses of "not at all," "a little," "a lot," or "very much." These questions evaluate the 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 question was scored using a 4-point scale ranging from 0 to 3 based on a participant's response: not at all/not relevant (0), a little (1), a lot (2) and very much (3). The total score of the DLQI ranged from 0 to 30 and was calculated by adding up the scores from each question. The higher the score, the greater the impact on a participant's QoL. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Baseline through Day 115 | TEAEs are defined as AEs with an onset date on or after the date of first administration of study drug and before the date of last administration of study drug + 30 days. A summary of non-serious AEs and serious AEs, regardless of causality is located in Reported AEs section. |
| Secondary | ATI-450 and Metabolite (CDD-2164) Concentrations | 2 hours postdose on Days 1, 8, and 85 |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 12 | Baseline, Week 12 | FAS population: All participants who were randomized and administered at least 1 dose of study drug. | AN count | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 12 | Week 12 | FAS population: All participants who were randomized and administered at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS-4) at Week 12 | Baseline, Week 12 | FAS population: All participants who were randomized and administered at least 1 dose of study drug. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving NRS30 | Week 12 | Only participants in the FAS population with a baseline NRS-PGA -SP ≥3 were evaluated for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Hidradenitis Suppurativa-Physician Global Assessment (HSPGA) at Week 12 | Baseline, Week 12 | FAS population: All participants who were randomized and administered at least 1 dose of study drug. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 12 | Baseline, Week 12 | FAS population: All participants who were randomized and administered at least 1 dose of study drug. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Baseline through Day 115 | Safety population: All participants randomly assigned to study drug and who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | ATI-450 and Metabolite (CDD-2164) Concentrations | 2 hours postdose on Days 1, 8, and 85 | Pharmacokinetic (PK) population: All participants who were randomized, took at least 1 dose of study drug, and had at least 1 evaluable PK assay. Here, 'Number analyzed' = participants evaluable for specified category. | Nanograms per milliliter (ng/ml) | MEAN |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 12 | ATI-450 | -2.93 | 90% Confidence Interval -3.99 to -1.87 | AN count | |
| Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 12 | Placebo | -5.94 | 90% Confidence Interval -7.01 to -4.87 | AN count | |
| Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 12 | ATI-450 | 31.5 | 90% Confidence Interval 21.6 to 43.4 | percentage of participants | |
| Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 12 | Placebo | 51.4 | 90% Confidence Interval 39.5 to 63.2 | percentage of participants | |
| Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS-4) at Week 12 | ATI-450 | -4.01 | 90% Confidence Interval -6.31 to -1.71 | units on a scale | |
| Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS-4) at Week 12 | Placebo | -11.86 | 90% Confidence Interval -14.18 to -9.53 | units on a scale | |
| Percentage of Participants Achieving NRS30 | ATI-450 | 43.7 | 90% Confidence Interval 30.9 to 57.3 | percentage of participants | |
| Percentage of Participants Achieving NRS30 | Placebo | 57.5 | 90% Confidence Interval 44.0 to 69.9 | percentage of participants | |
| Change From Baseline in Hidradenitis Suppurativa-Physician Global Assessment (HSPGA) at Week 12 | ATI-450 | -0.31 | 90% Confidence Interval -0.48 to -0.14 | units on a scale | |
| Change From Baseline in Hidradenitis Suppurativa-Physician Global Assessment (HSPGA) at Week 12 | Placebo | -0.73 | 90% Confidence Interval -0.90 to -0.55 | units on a scale |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ATI-450 | 48 | |
| Overall Study | STARTED | Placebo | 47 | |
| Overall Study | Received at Least 1 Dose of Study Drug | ATI-450 | 48 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Placebo | 47 | |
| Overall Study | COMPLETED | ATI-450 | 25 | |
| Overall Study | COMPLETED | Placebo | 32 | |
| Overall Study | NOT COMPLETED | ATI-450 | 23 | |
| Overall Study | NOT COMPLETED | Placebo | 15 |
Source ClinicalTrials.gov
Adverse events22
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | ATI-450 | 6 | 48 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 4 | 47 | |
| other | Nausea | Gastrointestinal disorders | ATI-450 | 2 | 48 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 3 | 47 | |
| other | Mouth ulceration | Gastrointestinal disorders | ATI-450 | 3 | 48 | |
| other | Mouth ulceration | Gastrointestinal disorders | Placebo | 0 | 47 | |
| other | Fatigue | General disorders | ATI-450 | 3 | 48 | |
| other | Fatigue | General disorders | Placebo | 0 | 47 | |
| other | Nasopharyngitis | Infections and infestations | ATI-450 | 1 | 48 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 5 | 47 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ATI-450 | 0 | 48 |
| Total, all-cause mortality | Placebo | 0 | 47 |
| Total, other adverse events | ATI-450 | 23 | 48 |
| Total, other adverse events | Placebo | 13 | 47 |
| Total, serious adverse events | ATI-450 | 0 | 48 |
| Total, serious adverse events | Placebo | 1 | 47 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| ATI-450 vs Placebo: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Trial comparisons |
| ATI-450 vs Placebo: deaths from any cause | Trial comparisons |
| ATI-450 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05216224
GET https://conductscience.org/api/trials/v1/NCT05216224/results?page=2