Trial · NCT03818035
A Study to Evaluate Further Therapeutic Strategies With Guselkumab in Participants With Moderate-to-Severe Plaque-Type Psoriasis
NCT03818035, Phase 3, Completed, Janssen-Cilag International NV; results first posted 2023-05-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate Further Therapeutic Strategies With Guselkumab in Participants With Moderate-to-Severe Plaque-Type Psoriasis. Trials, record NCT03818035. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03818035
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Further Therapeutic Strategies With Guselkumab in Participants With Moderate-to-Severe Plaque-Type Psoriasis
- NCT number
- NCT03818035
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 880 participants, actual
- Lead sponsor
- Janssen-Cilag International NV
- Conditions
- Psoriasis
- Interventions
- Guselkumab, Placebo Injection
- First posted
- 2019-01-28
- Last updated
- 2026-01-23
- Other registries' IDs
- eudract:2018-001238-16
- Results first posted
- 2023-05-10
- Limitations and caveats
- There was an interruption of enrollment due to Corona Pandemic.
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Group 2a and Group 2b: Percentage of Participants Who Achieved an Absolute Psoriasis Area and Severity Index (PASI) Score Less Than (<) 3 at Week 68 | Week 68 | Percentage of participants who achieved an absolute PASI \<3 at Week 68 were reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the body surface area involved, which translates to a numeric score that ranged from 0 (indicated no involvement) to 6 (90 percent \[%\]-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. |
| Secondary | Groups 1 and 2c: Time to Improvement From Baseline (Week 0) in PASI Score | Group 1: Week 0 up to Week 28; Group 2c: Week 28 up to Week 68 | Time to improvement from baseline in PASI 75/90/100 response for participants with short disease duration (SDD) and longer disease duration (LDD) was reported. PASI was used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translates to numeric score that ranged from 0 (no involvement) to 6 (90-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced numeric score ranging from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease. PASI responders were participants with \>=75%, \>=90%, 100% improvement in PASI respectively. For Part 2, data is reported only for those groups in which participants had PASI improvement post Week 28. |
| Secondary | Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants With Short (<=2 Years) and Longer (>2 Years) Disease Duration Who Achieved an Absolute PASI Score of 0, <=1 and <3 at Weeks 20, 28, 68, 116, 164 and 220 | Group 1: Weeks 20 and 28; Groups 2a, 2b, 2c: Week 68; Groups 3a and 3b: Weeks 116, 164 and 220 | Percentage of participants with short (\<=2 years) and longer (\>2 years) disease duration who achieved an absolute PASI Score of 0, \<=1 and less than (\<) 3 was reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease. |
| Secondary | Group 3a and Group 3b: Percentage of Participants With Short (<=2 Years) and Longer (>2 Years) Disease Duration Who Retain Disease Control (Absolute PASI Score < 3) | From Week 68 up to Week 220 | Percentage of participants who retain disease control (that is, absolute PASI score \<3 from Week 68 through Week 220 for participants with short (\<= 2 years) and longer (\>2 years) disease duration was reported. Control of disease was defined as participants with a PASI score \<3. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease |
| Secondary | Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants Who Achieved a PASI 75/90/100 Response at Weeks 20, 28, 68, 116, 164, and 220 | Group 1: Weeks 20, 28; Groups 2a, 2b, 2c: Week 68; Groups 3a, 3b: Weeks 116, 164 and 220 | Percentage of participants who achieved PASI 75/90/100 response were reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease. PASI 75 responders were defined as participants with \>= 75% improvement in PASI from baseline. PASI 90 responders were defined as participants with \>= 90% improvement in PASI from baseline. PASI 100 responders were defined as participants with 100% improvement in PASI from baseline. |
| Secondary | Group 3a and Group 3b: Time to Loss of Disease Control (Absolute PASI Score >5) After Treatment Withdrawal | From Week 68 up to Week 220 | Time to loss of disease control (absolute PASI score \>5) after treatment withdrawal beyond Week 68 up to Week 220 were reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease. |
| Secondary | Group 1: Percentage of Participants With an Absolute PASI Score = 0 at Weeks 12, 16, 20 and 28 | Weeks 12, 16, 20 and 28 | Percentage of participants with an absolute PASI score = 0 at Weeks 12, 16, 20 and 28 were reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease. |
| Secondary | Groups 1, 2a, 2b, 2c, 3a, 3b and 3c: Change From Baseline (Week 0) in Dermatology Life Quality Index (DLQI) Score | Group 1: Baseline (Week 0), Week 28; Group 2a, 2b, 2c: Baseline (Week 0), Week 68; Group 3a and Group 3b:Baseline (Week 0), Week 116, 164 and 220; Group 3c: Baseline (Re-Treatment [R] Week 0), Week R24 | Change from baseline (Week 0) in DLQI score were reported. DLQI was a 10-item instrument questionnaire designed to assess the impact of the disease on a participant's quality of life. Each question was evaluated on a 4-point scale ranged from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. |
| Secondary | Groups 1, 2a, 2b, 2c, 3a, 3b and 3c: Percentage of Participants Who Achieved a DLQI Score 0/1 and <5 | Group 1: Week 28; Groups 2a, 2b, 2c: Week 68; Groups 3a and 3b: Week 116, 164 and 220; Group 3c: Week R24 | Percentage of participants who achieved a DLQI score 0/1 and \<5 was reported. DLQI was a 10-item instrument questionnaire designed to assess the impact of the disease on a participant's quality of life. Each question was evaluated on a 4-point scale ranged from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. |
| Secondary | Groups 1, 2a, 2b, 2c, 3a, and 3b: Percent Change From Baseline (Week 0) in Psoriasis- Affected Body Surface Area (BSA) | Group 1: Baseline (Week 0), Week 12, 28; Group 2a, 2b, 2c: Baseline (Week 0), Week 52 and 68, Group 3a, 3b: Baseline (Week 0), Week 80, 104, 116, 140, 164, 188, 212 and 220 | Percent change from baseline in the psoriasis affected BSA (%) was reported. The percentage of the psoriasis-affected BSA percentage is a system used for assessing the severity of psoriasis. The plaque coverage is estimated using the rule of palm (1 palm of the hand = 1% BSA) |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Group 2a and Group 2b: Percentage of Participants Who Achieved an Absolute Psoriasis Area and Severity Index (PASI) Score Less Than (<) 3 at Week 68 | Week 68 | For part 2, ITT analysis set included all randomized participants at week 28 or treated with at least one dose of study agent within study part 2 (study group 2c). | Percentage of participants | NUMBER |
| SECONDARY | Groups 1 and 2c: Time to Improvement From Baseline (Week 0) in PASI Score | Group 1: Week 0 up to Week 28; Group 2c: Week 28 up to Week 68 | ITT analysis set for part 1 included all participants treated with at least one dose of study agent. For part 2, ITT analysis set included all randomized participants at week 28 or treated with at least one dose of study agent within study part 2 (study group 2c). | Days | MEDIAN |
| SECONDARY | Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants With Short (<=2 Years) and Longer (>2 Years) Disease Duration Who Achieved an Absolute PASI Score of 0, <=1 and <3 at Weeks 20, 28, 68, 116, 164 and 220 | Group 1: Weeks 20 and 28; Groups 2a, 2b, 2c: Week 68; Groups 3a and 3b: Weeks 116, 164 and 220 | ITT analysis set for part 1 included all participants treated with at least one dose of study agent. For part 2, ITT analysis set was used. Part 3, ITT set=all participants entering Part 3. N (overall number of participants analyzed)= number of participants evaluable for this outcome measure and 'n' (number analyzed)=number of participants analyzed at specified timepoints. n=0 signifies that timepoint was not applicable for that arm. | Percentage of participants | NUMBER |
| SECONDARY | Group 3a and Group 3b: Percentage of Participants With Short (<=2 Years) and Longer (>2 Years) Disease Duration Who Retain Disease Control (Absolute PASI Score < 3) | From Week 68 up to Week 220 | For part 3, ITT analysis set included all participants entering study part 3 (either group 3a or 3b). | Percentage of participants | NUMBER |
| SECONDARY | Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants Who Achieved a PASI 75/90/100 Response at Weeks 20, 28, 68, 116, 164, and 220 | Group 1: Weeks 20, 28; Groups 2a, 2b, 2c: Week 68; Groups 3a, 3b: Weeks 116, 164 and 220 | For part 1 and 2, ITT analysis set was used. For part 3, ITT analysis set included all participants entering study part 3. n=0 signifies that specific timepoint was not applicable for that arm. Here 'n' (number analyzed) signifies number of participants analyzed at specified timepoints | Percentage of participants | NUMBER |
| SECONDARY | Group 3a and Group 3b: Time to Loss of Disease Control (Absolute PASI Score >5) After Treatment Withdrawal | From Week 68 up to Week 220 | For part 3, ITT analysis set included all participants entering study part 3 (either group 3a or 3b). | Days | MEDIAN |
| SECONDARY | Group 1: Percentage of Participants With an Absolute PASI Score = 0 at Weeks 12, 16, 20 and 28 | Weeks 12, 16, 20 and 28 | ITT analysis set for part 1 included all participants treated with at least one dose of study agent. | Percentage of participants | NUMBER |
| SECONDARY | Groups 1, 2a, 2b, 2c, 3a, 3b and 3c: Change From Baseline (Week 0) in Dermatology Life Quality Index (DLQI) Score | Group 1: Baseline (Week 0), Week 28; Group 2a, 2b, 2c: Baseline (Week 0), Week 68; Group 3a and Group 3b:Baseline (Week 0), Week 116, 164 and 220; Group 3c: Baseline (Re-Treatment [R] Week 0), Week R24 | For part 1 and 2 ITT analysis set was used. For part 3, ITT analysis set included all participants entering study part 3. Here 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. n=0, signifies that specified timepoint was not applicable for that arm. | Score on scale | MEAN |
| SECONDARY | Groups 1, 2a, 2b, 2c, 3a, 3b and 3c: Percentage of Participants Who Achieved a DLQI Score 0/1 and <5 | Group 1: Week 28; Groups 2a, 2b, 2c: Week 68; Groups 3a and 3b: Week 116, 164 and 220; Group 3c: Week R24 | For part 1, 2 and 3 ITT analysis set was used. Here 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. n=0 signifies that timepoint was not applicable for that arm. | Percentage of participants | NUMBER |
| SECONDARY | Groups 1, 2a, 2b, 2c, 3a, and 3b: Percent Change From Baseline (Week 0) in Psoriasis- Affected Body Surface Area (BSA) | Group 1: Baseline (Week 0), Week 12, 28; Group 2a, 2b, 2c: Baseline (Week 0), Week 52 and 68, Group 3a, 3b: Baseline (Week 0), Week 80, 104, 116, 140, 164, 188, 212 and 220 | For part 1, 2 and 3 ITT analysis set was used. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. n=0, signifies that specified timepoint was not applicable for that arm.. | Percent Change | MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group254
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Group 2a and Group 2b: Percentage of Participants Who Achieved an Absolute Psoriasis Area and Severity Index (PASI) Score Less Than (<) 3 at Week 68 | Part 2 Group 2a: Guselkumab 100 mg Q8W | 92.6 | 90% Confidence Interval 88.0 to 95.8 | Percentage of participants | |
| Group 2a and Group 2b: Percentage of Participants Who Achieved an Absolute Psoriasis Area and Severity Index (PASI) Score Less Than (<) 3 at Week 68 | Part 2 Group 2b: Guselkumab 100 mg Q16W | 91.9 | 90% Confidence Interval 87.3 to 95.3 | Percentage of participants | |
| Groups 1 and 2c: Time to Improvement From Baseline (Week 0) in PASI Score | Part 1 Group 1: Participants With Disease Duration <= 2 Years | PASI 75 | 84.0 | Inter-Quartile Range 81.0 to 89.0 | Days |
| Groups 1 and 2c: Time to Improvement From Baseline (Week 0) in PASI Score | Part 1 Group 1: Participants With Disease Duration > 2 Years | PASI 75 | 84.0 | Inter-Quartile Range 81.0 to 90.0 | Days |
| Groups 1 and 2c: Time to Improvement From Baseline (Week 0) in PASI Score | Part 2 Group 2c: Participants With Disease Duration <= 2 Years | PASI 75 | 84.0 | Inter-Quartile Range 83.0 to 112.0 | Days |
| Groups 1 and 2c: Time to Improvement From Baseline (Week 0) in PASI Score | Part 2 Group 2c: Participants With Duration > 2 Years | PASI 75 | 84.0 | Inter-Quartile Range 83.0 to 105.0 | Days |
| Groups 1 and 2c: Time to Improvement From Baseline (Week 0) in PASI Score | Part 1 Group 1: Participants With Disease Duration <= 2 Years | PASI 90 | 89.0 | Inter-Quartile Range 84.0 to 134.0 | Days |
| Groups 1 and 2c: Time to Improvement From Baseline (Week 0) in PASI Score | Part 1 Group 1: Participants With Disease Duration > 2 Years | PASI 90 | 106.0 | Inter-Quartile Range 84.0 to 140.0 | Days |
| Groups 1 and 2c: Time to Improvement From Baseline (Week 0) in PASI Score | Part 2 Group 2c: Participants With Disease Duration <= 2 Years | PASI 90 | 112.0 | Inter-Quartile Range 84.0 to 153.0 | Days |
| Groups 1 and 2c: Time to Improvement From Baseline (Week 0) in PASI Score | Part 2 Group 2c: Participants With Duration > 2 Years | PASI 90 | 114.0 | Inter-Quartile Range 84.0 to 196.0 | Days |
1 to 10 of 254Source ClinicalTrials.gov
See all 254 results by groupParticipant flow104
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1: Open-label (Week 0 to Week 8) | STARTED | Part 1 Group 1: Guselkumab 100mg | 880 | |
| Part 1: Open-label (Week 0 to Week 8) | STARTED | Part 2 Group 2a: Guselkumab 100 mg Q8W | 0 | |
| Part 1: Open-label (Week 0 to Week 8) | STARTED | Part 2 Group 2b: Guselkumab 100 mg Q16W | 0 | |
| Part 1: Open-label (Week 0 to Week 8) | STARTED | Part 2 Group 2c: Guselkumab 100 mg Q8W | 0 | |
| Part 1: Open-label (Week 0 to Week 8) | STARTED | Part 2 Group 2d: Re-Treatment Guselkumab 100mg | 0 | |
| Part 1: Open-label (Week 0 to Week 8) | STARTED | Part 3 Group 3a: Withdrawal (Q8W) | 0 | |
| Part 1: Open-label (Week 0 to Week 8) | STARTED | Part 3 Group 3b: Withdrawal (Q16W) | 0 | |
| Part 1: Open-label (Week 0 to Week 8) | STARTED | Part 3 Group 3c: Re-Treatment Guselkumab 100mg | 0 | |
| Part 1: Open-label (Week 0 to Week 8) | COMPLETED | Part 1 Group 1: Guselkumab 100mg | 822 | |
| Part 1: Open-label (Week 0 to Week 8) | COMPLETED | Part 2 Group 2a: Guselkumab 100 mg Q8W | 0 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 participant flowAdverse events5,968
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 | Iron Deficiency Anaemia | Blood and lymphatic system disorders | Part 1 Group 1: Guselkumab 100mg | 0 | 880 | |
| other | Iron Deficiency Anaemia | Blood and lymphatic system disorders | Group 2a: Guselkumab 100 mg Q8W | 0 | 148 | |
| other | Iron Deficiency Anaemia | Blood and lymphatic system disorders | Group 2b: Guselkumab 100 mg Q16W | 0 | 149 | |
| other | Iron Deficiency Anaemia | Blood and lymphatic system disorders | Group 2c: Guselkumab 100 mg Q8W | 1 | 525 | |
| other | Iron Deficiency Anaemia | Blood and lymphatic system disorders | Part 2 Group 2d: Re-Treatment Guselkumab 100mg | 0 | 9 | |
| other | Iron Deficiency Anaemia | Blood and lymphatic system disorders | Group 3a Guselkumab 100 mg Q8W | 0 | 136 | |
| other | Iron Deficiency Anaemia | Blood and lymphatic system disorders | Group 3b Guselkumab 100 mg Q16W | 0 | 137 | |
| other | Iron Deficiency Anaemia | Blood and lymphatic system disorders | Group 3c Guselkumab 100 mg | 0 | 227 | |
| other | Leukopenia | Blood and lymphatic system disorders | Part 1 Group 1: Guselkumab 100mg | 0 | 880 | |
| other | Leukopenia | Blood and lymphatic system disorders | Group 2a: Guselkumab 100 mg Q8W | 0 | 148 |
1 to 10 of 5,968Source ClinicalTrials.gov
See all 5,968 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1 Group 1: Guselkumab 100mg | 1 | 880 |
| Total, all-cause mortality | Group 2a: Guselkumab 100 mg Q8W | 0 | 148 |
| Total, all-cause mortality | Group 2b: Guselkumab 100 mg Q16W | 0 | 150 |
| Total, all-cause mortality | Group 2c: Guselkumab 100 mg Q8W | 1 | 525 |
| Total, all-cause mortality | Part 2 Group 2d: Re-Treatment Guselkumab 100mg | 0 | 9 |
| Total, all-cause mortality | Group 3a Guselkumab 100 mg Q8W | 0 | 136 |
| Total, all-cause mortality | Group 3b Guselkumab 100 mg Q16W | 0 | 137 |
| Total, all-cause mortality | Group 3c Guselkumab 100 mg | 0 | 227 |
| Total, other adverse events | Part 1 Group 1: Guselkumab 100mg | 631 | 880 |
| Total, other adverse events | Group 2a: Guselkumab 100 mg Q8W | 101 | 148 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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